Trial Evaluating Postop Pain and Muscle Strength Among Regional Anesthesia Techniques for Ambulatory ACL Reconstruction
Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02584452
Collaborator
(none)
59
1
2
29.2
2
Study Details
Study Description
Brief Summary
Despite the apparent multifaceted benefit in differentiating blockade sites and duration of nerve blockade, the efficacy of continuous adductor canal blockade utilized specifically in ACL reconstruction has not been extensively studied. This study will test the hypothesis that the use of the adductor canal continuous nerve catheter will result in lower subjective pain scores on postoperative day 2 and improved quadriceps strength on postoperative day 1.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Study participants will be randomized to 2 groups: (1) continuous adductor canal nerve catheter or (2) long-acting single bolus adductor canal nerve block.
Following random selection via random envelope selection patients will receive the following procedures. Both groups will receive ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time.
Intraoperative care will consist of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert, Group 1 patients 1 will receive ultrasound guided adductor canal continuous nerve catheter using normal saline as bolus for placement, followed by initiation of 1/8% bupivacaine infusion through catheter at 8cc/h. Group 2 will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine + 2mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve14. After adequate instruction including catheter education (if applicable) patients are to be discharged home.
Study Design
Study Type:
Interventional
Actual Enrollment
:
59 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial Evaluating Postoperative Analgesia and Muscle Strength Between Single Versus Continuous Adductor Canal Block for Ambulatory ACL Reconstruction.
Actual Study Start Date
:
Nov 3, 2015
Actual Primary Completion Date
:
Mar 1, 2018
Actual Study Completion Date
:
Apr 10, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Continuous Adductor Canal Nerve Catheter Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. |
Drug: Mepivacaine
20cc of 2% mepivacaine <20 minutes prior to in room time.
Other Names:
Procedure: adductor canal continuous nerve catheter
Placement of ultrasound guided adductor canal continuous nerve catheter
Drug: Normal Saline as bolus followed by bupivacaine
normal saline as bolus for placement, followed by initiation of 1/8% bupivacaine infusion through adductor canal catheter at 8cc/h
Other Names:
Drug: Propofol
Anesthesia induction will include a propofol bolus.
Other Names:
Drug: Fentanyl
Intraoperative opioid should be limited to no more than 150mcg of fentanyl.
Other Names:
|
| Active Comparator: Long Acting Single Bolus Adductor Canal Nerve Block Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. |
Drug: Mepivacaine
20cc of 2% mepivacaine <20 minutes prior to in room time.
Other Names:
Procedure: adductor canal nerve block
ultrasound guided adductor canal nerve block
Drug: ropivacaine and dexamethasone
10cc of 0.5% ropivacaine + 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve
Other Names:
Drug: Propofol
Anesthesia induction will include a propofol bolus.
Other Names:
Drug: Fentanyl
Intraoperative opioid should be limited to no more than 150mcg of fentanyl.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Subjective Postoperative Pain Scores After Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postop Saphenous Nerve Block at 48 Hours After Discharge From PACU. [Post Operative Day 2]
Subjective subjective postoperative pain scores at POD 2 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block at 48 hours after discharge from PACU using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).
- Quadriceps Strength of on POD 1 of Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block at 48 Hours After Discharge From PACU [Post Operative Day 1]
Quadriceps strength on POD 1 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block using Straight Leg Raise Tests, 0-5/5 scale, and knee extension, 0-5/5 scale. On both scales (straight leg raise test and knee extension) 0 indicates the minimum value (low muscle contraction/no movement) and 5 indicates the maximum (normal muscle contraction /pt holds position against pressure).
Secondary Outcome Measures
- Subjective Pain Scores on POD 1 of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block [Post Operative Day 1]
Subjective pain scores on POD 1 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).
- Total Postop Opioid Consumption of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block. [Post Operative Day 2 and 3]
Total postop opioid consumption measured by total pain pills on POD 2 and 3 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block.
- Quadriceps Strength on POD Week 6- Pts Receiving (1) Long-acting Single Bolus Adductor Canal Nerve Block Comparied to (2) Continuous Adductor Canal Nerve Catheter. [Post Operative Week 6]
Quadriceps strength on POD week 6- pts receiving (1) long-acting single bolus adductor canal nerve block comparied to (2) continuous adductor canal nerve catheter using Straight Leg Raise Tests, 0-5/5 scale, and knee extension, 0-5/5 scale. On both scales (straight leg raise test and knee extension) 0 indicates the minimum value (low muscle contraction/no movement) and 5 indicates the maximum (normal muscle contraction /pt holds position against pressure).
- Physical Therapy Participation With a Subjective Assessment of Participant Ability to Participate in PT (Full, Partial, None) [Post Operative Day 1]
- Subjective Postoperative Pain Score at Post Operative Week 6 of Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block [Post Operative Week 6]
Subjective postoperative pain score at post operative week 6 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score with and without activity (on an 11 point scale when 0 is no pain and 10 is worst pain).
- Evaluation of Ambulation at Post Operative Week 6 Assessing Independently vs Assistance, With or Without Pain [Post Operative Week 6]
- Postoperative Nausea and Vomiting [POD 1 following discharge from PACU]
Postoperative nausea and vomiting score on POD 1 following discharge from PACU
- Subjective Assessment of Experience With Analgesia [Post Operative Week 6]
Subjective assessment of experience with analgesia at post operative week 6 using rating of below expectations; met expectations; exceeded expectations
- Subjective Pain Scores on POD 3 of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block [Post Operative Day 3]
Subjective pain scores on POD 3 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).
- Total Postop Opioid Consumption of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block. [Post Operative Day1]
Total postop opioid consumption measured by total pain pills on POD 1 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block.
Eligibility Criteria
Criteria
Ages Eligible for Study:
14 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age 14 and older
-
Patients who are scheduled to undergo an ACL reconstruction with patella or allograft
-
Patient does not have a contraindication to receiving regional anesthesia
Exclusion Criteria:
-
Allergy to local anesthetics, dexamethasone, or adhesive tape
-
Patients undergoing hamstring graft for ACL
-
Preexisting infection at site of needle insertion
-
Immunocompromised patients
-
Preexisting sensory or motor deficit in operative extremity
-
Patient on chronic opioid treatment.
-
Patient having a revision of previous ACL reconstruction.
-
Pregnancy and lactating women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37212 |
Sponsors and Collaborators
- Vanderbilt University Medical Center
Investigators
- Principal Investigator: Christopher Sobey, MD, Vanderbilt University Medical Center
Study Documents (Full-Text)
More Information
Publications
- Andersen HL, Andersen SL, Tranum-Jensen J. The spread of injectate during saphenous nerve block at the adductor canal: a cadaver study. Acta Anaesthesiol Scand. 2015 Feb;59(2):238-45. doi: 10.1111/aas.12451. Epub 2014 Dec 14.
- Chisholm MF, Bang H, Maalouf DB, Marcello D, Lotano MA, Marx RG, Liguori GA, Zayas VM, Gordon MA, Jacobs J, YaDeau JT. Postoperative Analgesia with Saphenous Block Appears Equivalent to Femoral Nerve Block in ACL Reconstruction. HSS J. 2014 Oct;10(3):245-51. doi: 10.1007/s11420-014-9392-x. Epub 2014 Jun 7.
- Espelund M, Fomsgaard JS, Haraszuk J, Dahl JB, Mathiesen O. The efficacy of adductor canal blockade after minor arthroscopic knee surgery--a randomised controlled trial. Acta Anaesthesiol Scand. 2014 Mar;58(3):273-80. doi: 10.1111/aas.12224. Epub 2013 Nov 8.
- Espelund M, Fomsgaard JS, Haraszuk J, Mathiesen O, Dahl JB. Analgesic efficacy of ultrasound-guided adductor canal blockade after arthroscopic anterior cruciate ligament reconstruction: a randomised controlled trial. Eur J Anaesthesiol. 2013 Jul;30(7):422-8. doi: 10.1097/EJA.0b013e328360bdb9.
- Espelund M, Grevstad U, Jaeger P, Hölmich P, Kjeldsen L, Mathiesen O, Dahl JB. Adductor canal blockade for moderate to severe pain after arthroscopic knee surgery: a randomized controlled trial. Acta Anaesthesiol Scand. 2014 Nov;58(10):1220-7. doi: 10.1111/aas.12407.
- Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.
- Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
- Jæger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.
- Jenstrup MT, Jæger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
- Johnson RL, Kopp SL, Hebl JR, Erwin PJ, Mantilla CB. Falls and major orthopaedic surgery with peripheral nerve blockade: a systematic review and meta-analysis. Br J Anaesth. 2013 Apr;110(4):518-28. doi: 10.1093/bja/aet013. Epub 2013 Feb 24. Review.
- Lewek M, Rudolph K, Axe M, Snyder-Mackler L. The effect of insufficient quadriceps strength on gait after anterior cruciate ligament reconstruction. Clin Biomech (Bristol, Avon). 2002 Jan;17(1):56-63.
- Lund J, Jenstrup MT, Jaeger P, Sørensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.
- Mizner RL, Petterson SC, Snyder-Mackler L. Quadriceps strength and the time course of functional recovery after total knee arthroplasty. J Orthop Sports Phys Ther. 2005 Jul;35(7):424-36.
- Mudumbai SC, Kim TE, Howard SK, Workman JJ, Giori N, Woolson S, Ganaway T, King R, Mariano ER. Continuous adductor canal blocks are superior to continuous femoral nerve blocks in promoting early ambulation after TKA. Clin Orthop Relat Res. 2014 May;472(5):1377-83. doi: 10.1007/s11999-013-3197-y.
- Mulroy MF, Larkin KL, Batra MS, Hodgson PS, Owens BD. Femoral nerve block with 0.25% or 0.5% bupivacaine improves postoperative analgesia following outpatient arthroscopic anterior cruciate ligament repair. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):24-9.
Responsible Party:
Christopher Sobey,
Assistant Professor of Anesthesiology & Pain Medicine,
Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT02584452
Other Study ID Numbers:
- 151095
First Posted:
Oct 22, 2015
Last Update Posted:
Dec 11, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Two participants consented but withdrew from the study prior to randomization. |
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long Acting Single Bolus Adductor Canal Nerve Block |
|---|---|---|
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Patients then undergo general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction with propofol bolus and placement of laryngeal mask airway. Intraoperative opioid limited to no > 150mcg of fentanyl. Completion of procedure, dressing and LMA revoved with patients transferred to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Patients then undergo general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no > 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc. |
| Period Title: Overall Study | ||
| STARTED | 34 | 23 |
| COMPLETED | 32 | 21 |
| NOT COMPLETED | 2 | 2 |
Baseline Characteristics
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long Acting Single Bolus Adductor Canal Nerve Block | Total |
|---|---|---|---|
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal | Ultrasound guided femoral nerve block with 20cc 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv | Total of all reporting groups |
| Overall Participants | 32 | 21 | 53 |
| Age (Count of Participants) | |||
| <=18 years |
12
37.5%
|
9
42.9%
|
21
39.6%
|
| Between 18 and 65 years |
20
62.5%
|
12
57.1%
|
32
60.4%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
14
43.8%
|
5
23.8%
|
19
35.8%
|
| Male |
18
56.3%
|
16
76.2%
|
34
64.2%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Region of Enrollment (participants) [Number] | |||
| United States |
32
100%
|
21
100%
|
53
100%
|
Outcome Measures
| Title | Subjective Postoperative Pain Scores After Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postop Saphenous Nerve Block at 48 Hours After Discharge From PACU. |
|---|---|
| Description | Subjective subjective postoperative pain scores at POD 2 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block at 48 hours after discharge from PACU using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain). |
| Time Frame | Post Operative Day 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was unavailable for 1 participant in the Long Acting Single Bolus Adductor Canal Nerve Block group. |
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long- Acting Single Bolus Adductor Canal Nerve Block |
|---|---|---|
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv |
| Measure Participants | 32 | 20 |
| 0 (Pain on Subjective Numeric Pain Scale) |
1
3.1%
|
1
4.8%
|
| 1 (Pain on Subjective Numeric Pain Scale) |
2
6.3%
|
0
0%
|
| 2 (Pain on Subjective Numeric Pain Scale) |
6
18.8%
|
3
14.3%
|
| 3 (Pain on Subjective Numeric Pain Scale) |
7
21.9%
|
4
19%
|
| 4 (Pain on Subjective Numeric Pain Scale) |
5
15.6%
|
4
19%
|
| 5 (Pain on Subjective Numeric Pain Scale) |
5
15.6%
|
1
4.8%
|
| 6 (Pain on Subjective Numeric Pain Scale) |
3
9.4%
|
2
9.5%
|
| 7 (Pain on Subjective Numeric Pain Scale) |
2
6.3%
|
2
9.5%
|
| 8 (Pain on Subjective Numeric Pain Scale) |
0
0%
|
3
14.3%
|
| 9 (Pain on Subjective Numeric Pain Scale) |
1
3.1%
|
0
0%
|
| Title | Quadriceps Strength of on POD 1 of Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block at 48 Hours After Discharge From PACU |
|---|---|
| Description | Quadriceps strength on POD 1 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block using Straight Leg Raise Tests, 0-5/5 scale, and knee extension, 0-5/5 scale. On both scales (straight leg raise test and knee extension) 0 indicates the minimum value (low muscle contraction/no movement) and 5 indicates the maximum (normal muscle contraction /pt holds position against pressure). |
| Time Frame | Post Operative Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was unavailable for 1 participant in both groups. |
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long-Acting Single Bolus Adductor Canal Nerve Block |
|---|---|---|
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv |
| Measure Participants | 31 | 20 |
| 0 |
1
3.1%
|
2
9.5%
|
| 1 |
3
9.4%
|
7
33.3%
|
| 2 |
9
28.1%
|
4
19%
|
| 3 |
8
25%
|
2
9.5%
|
| 4 |
8
25%
|
4
19%
|
| 5 |
2
6.3%
|
1
4.8%
|
| 0 |
2
6.3%
|
2
9.5%
|
| 1 |
2
6.3%
|
3
14.3%
|
| 2 |
11
34.4%
|
9
42.9%
|
| 3 |
9
28.1%
|
3
14.3%
|
| 4 |
6
18.8%
|
2
9.5%
|
| 5 |
1
3.1%
|
1
4.8%
|
| Title | Subjective Pain Scores on POD 1 of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block |
|---|---|
| Description | Subjective pain scores on POD 1 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain). |
| Time Frame | Post Operative Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long-Acting Single Bolus Adductor Canal Nerve Block |
|---|---|---|
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv |
| Measure Participants | 32 | 21 |
| 0 (Pain on Subjective Numeric Pain Scale) |
1
3.1%
|
0
0%
|
| 1 (Pain on Subjective Numeric Pain Scale) |
2
6.3%
|
1
4.8%
|
| 2 (Pain on Subjective Numeric Pain Scale) |
3
9.4%
|
1
4.8%
|
| 3 (Pain on Subjective Numeric Pain Scale) |
11
34.4%
|
5
23.8%
|
| 4 (Pain on Subjective Numeric Pain Scale) |
3
9.4%
|
2
9.5%
|
| 5 (Pain on Subjective Numeric Pain Scale) |
5
15.6%
|
2
9.5%
|
| 6 (Pain on Subjective Numeric Pain Scale) |
4
12.5%
|
4
19%
|
| 7 (Pain on Subjective Numeric Pain Scale) |
2
6.3%
|
1
4.8%
|
| 7.5 (Pain on Subjective Numeric Pain Scale) |
0
0%
|
1
4.8%
|
| 8 (Pain on Subjective Numeric Pain Scale) |
1
3.1%
|
4
19%
|
| Title | Total Postop Opioid Consumption of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block. |
|---|---|
| Description | Total postop opioid consumption measured by total pain pills on POD 2 and 3 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block. |
| Time Frame | Post Operative Day 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was unavailable for 1 participant in the Long Acting Single Bolus Adductor Canal Nerve Block group on post operative days 2 and 3. |
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long-Acting Single Bolus Adductor Canal Nerve Block |
|---|---|---|
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv |
| Measure Participants | 32 | 20 |
| 0 pills |
3
9.4%
|
0
0%
|
| 1 pill |
0
0%
|
1
4.8%
|
| 2 pills |
2
6.3%
|
1
4.8%
|
| 3 pills |
1
3.1%
|
2
9.5%
|
| 4 pills |
6
18.8%
|
3
14.3%
|
| 4.5 pills |
0
0%
|
0
0%
|
| 5 pills |
9
28.1%
|
1
4.8%
|
| 6 pills |
2
6.3%
|
5
23.8%
|
| 7 pills |
2
6.3%
|
0
0%
|
| 8 pills |
6
18.8%
|
1
4.8%
|
| 9 pills |
0
0%
|
1
4.8%
|
| 10 pills |
1
3.1%
|
1
4.8%
|
| 11 pills |
0
0%
|
2
9.5%
|
| 12 pills |
0
0%
|
2
9.5%
|
| 13 pills |
0
0%
|
0
0%
|
| 0 pills |
3
9.4%
|
1
4.8%
|
| 1 pill |
1
3.1%
|
0
0%
|
| 2 pills |
3
9.4%
|
2
9.5%
|
| 3 pills |
3
9.4%
|
1
4.8%
|
| 4 pills |
6
18.8%
|
2
9.5%
|
| 4.5 pills |
0
0%
|
1
4.8%
|
| 5 pills |
4
12.5%
|
4
19%
|
| 6 pills |
7
21.9%
|
2
9.5%
|
| 7 pills |
2
6.3%
|
0
0%
|
| 8 pills |
1
3.1%
|
2
9.5%
|
| 9 pills |
1
3.1%
|
0
0%
|
| 10 pills |
1
3.1%
|
1
4.8%
|
| 11 pills |
0
0%
|
1
4.8%
|
| 12 pills |
0
0%
|
2
9.5%
|
| 13 pills |
0
0%
|
1
4.8%
|
| Title | Quadriceps Strength on POD Week 6- Pts Receiving (1) Long-acting Single Bolus Adductor Canal Nerve Block Comparied to (2) Continuous Adductor Canal Nerve Catheter. |
|---|---|
| Description | Quadriceps strength on POD week 6- pts receiving (1) long-acting single bolus adductor canal nerve block comparied to (2) continuous adductor canal nerve catheter using Straight Leg Raise Tests, 0-5/5 scale, and knee extension, 0-5/5 scale. On both scales (straight leg raise test and knee extension) 0 indicates the minimum value (low muscle contraction/no movement) and 5 indicates the maximum (normal muscle contraction /pt holds position against pressure). |
| Time Frame | Post Operative Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was unavailable for 1 participant in each group. |
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long-Acting Single Bolus Adductor Canal Nerve Block |
|---|---|---|
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv |
| Measure Participants | 31 | 20 |
| 3 |
1
3.1%
|
1
4.8%
|
| 4 |
15
46.9%
|
9
42.9%
|
| 5 |
15
46.9%
|
10
47.6%
|
| 3 |
3
9.4%
|
3
14.3%
|
| 4 |
21
65.6%
|
12
57.1%
|
| 5 |
7
21.9%
|
5
23.8%
|
| Title | Physical Therapy Participation With a Subjective Assessment of Participant Ability to Participate in PT (Full, Partial, None) |
|---|---|
| Description | |
| Time Frame | Post Operative Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was unavailable for 1 participant in both groups. |
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long-Acting Single Bolus Adductor Canal Nerve Block |
|---|---|---|
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv |
| Measure Participants | 31 | 20 |
| Full participation |
27
84.4%
|
15
71.4%
|
| Partial participation |
4
12.5%
|
4
19%
|
| No participation |
0
0%
|
1
4.8%
|
| Title | Subjective Postoperative Pain Score at Post Operative Week 6 of Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block |
|---|---|
| Description | Subjective postoperative pain score at post operative week 6 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score with and without activity (on an 11 point scale when 0 is no pain and 10 is worst pain). |
| Time Frame | Post Operative Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was unavailable for 1 participant in each group. |
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long-Acting Single Bolus Adductor Canal Nerve Block |
|---|---|---|
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv |
| Measure Participants | 31 | 20 |
| 0 (Pain on Subjective Numeric Pain Scale) |
8
25%
|
9
42.9%
|
| 1 (Pain on Subjective Numeric Pain Scale) |
5
15.6%
|
1
4.8%
|
| 2 (Pain on Subjective Numeric Pain Scale) |
10
31.3%
|
1
4.8%
|
| 3 (Pain on Subjective Numeric Pain Scale) |
3
9.4%
|
3
14.3%
|
| 4 (Pain on Subjective Numeric Pain Scale) |
3
9.4%
|
3
14.3%
|
| 5 (Pain on Subjective Numeric Pain Scale) |
2
6.3%
|
3
14.3%
|
| 0 (Pain on Subjective Numeric Pain Scale) |
22
68.8%
|
14
66.7%
|
| 1 (Pain on Subjective Numeric Pain Scale) |
4
12.5%
|
4
19%
|
| 2 (Pain on Subjective Numeric Pain Scale) |
2
6.3%
|
1
4.8%
|
| 3 (Pain on Subjective Numeric Pain Scale) |
2
6.3%
|
1
4.8%
|
| 4 (Pain on Subjective Numeric Pain Scale) |
1
3.1%
|
0
0%
|
| 5 (Pain on Subjective Numeric Pain Scale) |
0
0%
|
0
0%
|
| Title | Evaluation of Ambulation at Post Operative Week 6 Assessing Independently vs Assistance, With or Without Pain |
|---|---|
| Description | |
| Time Frame | Post Operative Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was unavailable for 1 participant in each group. |
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long-Acting Single Bolus Adductor Canal Nerve Block |
|---|---|---|
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv |
| Measure Participants | 31 | 20 |
| Unassisted with pain |
6
18.8%
|
6
28.6%
|
| Unassisted without pain |
18
56.3%
|
9
42.9%
|
| Assisted with pain |
3
9.4%
|
2
9.5%
|
| Assisted without pain |
4
12.5%
|
3
14.3%
|
| Title | Postoperative Nausea and Vomiting |
|---|---|
| Description | Postoperative nausea and vomiting score on POD 1 following discharge from PACU |
| Time Frame | POD 1 following discharge from PACU |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long-Acting Single Bolus Adductor Canal Nerve Block |
|---|---|---|
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv |
| Measure Participants | 32 | 21 |
| No post operative nausea and vomiting |
28
87.5%
|
17
81%
|
| Yes post operative nausea and vomiting |
4
12.5%
|
4
19%
|
| Title | Subjective Assessment of Experience With Analgesia |
|---|---|
| Description | Subjective assessment of experience with analgesia at post operative week 6 using rating of below expectations; met expectations; exceeded expectations |
| Time Frame | Post Operative Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was unavailable for 1 participant in each group. |
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long-Acting Single Bolus Adductor Canal Nerve Block |
|---|---|---|
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv |
| Measure Participants | 31 | 20 |
| Below expectations |
0
0%
|
2
9.5%
|
| Met expectations |
13
40.6%
|
7
33.3%
|
| Exceeded expectations |
18
56.3%
|
11
52.4%
|
| Title | Subjective Pain Scores on POD 3 of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block |
|---|---|
| Description | Subjective pain scores on POD 3 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain). |
| Time Frame | Post Operative Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was unavailable for 1 participant in the Long Acting Single Bolus Adductor Canal Nerve Block group on post operative day 3. |
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long-Acting Single Bolus Adductor Canal Nerve Block |
|---|---|---|
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv |
| Measure Participants | 32 | 20 |
| 0 (Pain on Subjective Numeric Pain Scale) |
2
6.3%
|
2
9.5%
|
| 1 (Pain on Subjective Numeric Pain Scale) |
3
9.4%
|
1
4.8%
|
| 2 (Pain on Subjective Numeric Pain Scale) |
8
25%
|
2
9.5%
|
| 3 (Pain on Subjective Numeric Pain Scale) |
4
12.5%
|
5
23.8%
|
| 4 (Pain on Subjective Numeric Pain Scale) |
6
18.8%
|
1
4.8%
|
| 5 (Pain on Subjective Numeric Pain Scale) |
5
15.6%
|
3
14.3%
|
| 6 (Pain on Subjective Numeric Pain Scale) |
2
6.3%
|
3
14.3%
|
| 7 (Pain on Subjective Numeric Pain Scale) |
2
6.3%
|
1
4.8%
|
| 8 (Pain on Subjective Numeric Pain Scale) |
0
0%
|
2
9.5%
|
| Title | Total Postop Opioid Consumption of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block. |
|---|---|
| Description | Total postop opioid consumption measured by total pain pills on POD 1 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block. |
| Time Frame | Post Operative Day1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long-Acting Single Bolus Adductor Canal Nerve Block |
|---|---|---|
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv |
| Measure Participants | 32 | 21 |
| 0 pills |
1
3.1%
|
0
0%
|
| 1 pill |
1
3.1%
|
0
0%
|
| 2 pills |
1
3.1%
|
0
0%
|
| 3 pills |
3
9.4%
|
2
9.5%
|
| 4 pills |
3
9.4%
|
2
9.5%
|
| 4.5 pills |
0
0%
|
1
4.8%
|
| 5 pills |
2
6.3%
|
4
19%
|
| 6 pills |
8
25%
|
6
28.6%
|
| 7 pills |
2
6.3%
|
0
0%
|
| 8 pills |
7
21.9%
|
3
14.3%
|
| 10 pills |
2
6.3%
|
1
4.8%
|
| 12 pills |
2
6.3%
|
2
9.5%
|
Adverse Events
| Time Frame | Time of consent to 6 weeks after surgery (6 weeks) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Complaints and symptoms not existing prior to consent | |||
| Arm/Group Title | Continuous Adductor Canal Nerve Catheter | Long Acting Single Bolus Adductor Canal Nerve Block | ||
| Arm/Group Description | Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal continuous nerve catheter: Placement of ultrasound guided adductor canal continuous nerve catheter Normal Saline as bolus followed by bupivacaine: normal | Ultrasound guided femoral nerve block with 20cc 2% mepivacaine <20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve. Mepivacaine: 20cc of 2% mepivacaine <20 minutes prior to in room time. adductor canal nerve block: ultrasound guided adductor canal nerve block ropivacaine and dexamethasone: 10cc of 0.5% ropiv | ||
All Cause Mortality |
||||
| Continuous Adductor Canal Nerve Catheter | Long Acting Single Bolus Adductor Canal Nerve Block | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/34 (0%) | 0/23 (0%) | ||
Serious Adverse Events |
||||
| Continuous Adductor Canal Nerve Catheter | Long Acting Single Bolus Adductor Canal Nerve Block | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/34 (0%) | 0/23 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Continuous Adductor Canal Nerve Catheter | Long Acting Single Bolus Adductor Canal Nerve Block | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/34 (8.8%) | 4/23 (17.4%) | ||
| Gastrointestinal disorders | ||||
| Inflamed esophagus | 0/34 (0%) | 0 | 1/23 (4.3%) | 1 |
| Heartburn | 0/34 (0%) | 0 | 1/23 (4.3%) | 1 |
| Nausea | 0/34 (0%) | 0 | 2/23 (8.7%) | 2 |
| General disorders | ||||
| Dizziness | 1/34 (2.9%) | 1 | 1/23 (4.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Knee effusion | 0/34 (0%) | 0 | 2/23 (8.7%) | 2 |
| Surgical and medical procedures | ||||
| Leaking from insertion site | 2/34 (5.9%) | 2 | 0/23 (0%) | 0 |
| Vascular disorders | ||||
| Deep Vein Thrombosis | 0/34 (0%) | 0 | 1/23 (4.3%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Christopher Sobey, MD |
|---|---|
| Organization | Vanderbilt University Medical Center |
| Phone | 615-322-4311 |
| christopher.m.sobey@vumc.org |
Responsible Party:
Christopher Sobey,
Assistant Professor of Anesthesiology & Pain Medicine,
Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT02584452
Other Study ID Numbers:
- 151095
First Posted:
Oct 22, 2015
Last Update Posted:
Dec 11, 2019
Last Verified:
Nov 1, 2019