Adductor Canal Block Versus Periarticular Bupivicaine Injection in Total Knee Arthroplasty
Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT02777749
Collaborator
(none)
155
1
3
15.4
10
Study Details
Study Description
Brief Summary
The objective of the study is to compare the efficacy of adductor canal blocks versus periarticular bupivacaine injections for pain management in total knee arthroplasty. This randomized clinical trial will compare outcomes between adductor canal blocks, periarticular bupivacaine injections, and periarticular liposomal bupivacaine injections. Results from this study will help determine the most appropriate perioperative pain management strategy for patients undergoing a total knee arthroplasty.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
Over 600,000 total knee arthroplasties (TKAs) are performed each year in the United States, with expectations for greater than 4 million/year by the year 2030. Since the onset of TKAs in the 1960's, there have been developments that have improved both functionality and patient satisfaction. In the last decade, a focus has been made on multimodal pain management protocols, more rapid functional recovery, reduced length of hospital stay, and minimizing side effects of treatment while maintaining function and durability. The widespread use of regional anesthesia has led to improvements in pain control, more rapid functional recovery, and reduced length of stay. In recent years many surgeons have transitioned from femoral nerve blocks (proximal femoral nerve) to adductor canal blocks (distal femoral nerve) to maintain a sensory block for pain control, while minimizing any motor blockade that is typically seen in proximal femoral nerve blocks, which would hamper rehabilitation, and increase risk of falls. In addition to regional blocks, which are typically performed in the preoperative setting, some surgeons favor an intraoperative periarticular anesthetic injection (PAI), typically with bupivacaine or the long acting form liposomal bupivacaine, either in conjunction with an adductor canal block, or independently. In theory, PAI has the advantage of a comparable sensory nerve block as an adductor canal block, without the disadvantages and risks, which include prolonged quadriceps weakness, fall risk, and neurologic dysfunction.
The purpose of this randomized control trial is to compare the efficacy of adductor canal blocks versus periarticular bupivacaine injections for pain management in total knee arthroplasty.
Study Design
Study Type:
Interventional
Actual Enrollment
:
155 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Adductor Canal Block Versus Periarticular Bupivicaine Injection in Total Knee Arthroplasty
Actual Study Start Date
:
Jul 19, 2016
Actual Primary Completion Date
:
Sep 19, 2017
Actual Study Completion Date
:
Nov 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Adductor Canal Block 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. Adductor Canal Block (ACB) |
Drug: Bupivacaine
15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection
Other Names:
|
| Active Comparator: Periarticular SB 50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. |
Drug: Bupivacaine
15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection
Other Names:
|
| Active Comparator: ACB + SB 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. |
Drug: Bupivacaine
15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in VAS Pain Scores [Day 0 through Day 3]
Post-operatively, visual analog scale (VAS) pain scores will be recorded two times/day from Post-Operative Day (POD) 0 through POD3. VAS Scores range from 0 to 10, with 0 being "No Pain" and 10 being the "Worst Pain"
Secondary Outcome Measures
- Change in Activity Level [Day 0 and Day 1]
Daily steps taken will be recorded. The more steps taken daily the better. Minimum is 0 steps, maximum is unlimited.
- Opioid Consumption [Day 0 through Day 3]
Total amount of opioid consumption post-operatively will be recorded. The less opioids consumed (mg) postoperatively the better. A morphine equivalence metric will be used for equianalgesic comparison. Minimum is 0 mg, maximum is unlimited.
- Range of Knee Flexion [Postoperative day 21]
Range of knee flexion for active motion will be recorded at 3 week follow-up for all groups. The greater range of motion the better, with a good outcome considered at least 115 degrees of motion.
- Length of Hospital Stay [Up to Day 5]
Total length of hospital stay from time of surgery through time of discharge will be recorded. The shorter the length of stay (days) the better. Range 0 days to 5 days.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients undergoing an unilateral primary total knee arthroplasty under the care of the two senior arthroplasty surgeons.
Exclusion Criteria:
- Allergy to bupivicaine or liposomal bupivicaine.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Columbia University Medical Center | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Columbia University
Investigators
- Principal Investigator: Jeffrey Geller, MD, Columbia University
Study Documents (Full-Text)
More Information
Publications
- Berend ME, Berend KR, Lombardi AV Jr. Advances in pain management: game changers in knee arthroplasty. Bone Joint J. 2014 Nov;96-B(11 Supple A):7-9. doi: 10.1302/0301-620X.96B11.34514. Review.
- Berry J. Audience response-practice norm/trends. 22nd Annual Meeting of the American Association of Hip and Knee Surgeons. American Association of Hip and Knee Surgeons. November 2012.
- Cram P, Lu X, Kates SL, Singh JA, Li Y, Wolf BR. Total knee arthroplasty volume, utilization, and outcomes among Medicare beneficiaries, 1991-2010. JAMA. 2012 Sep 26;308(12):1227-36.
- Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169.
- Paul JE, Arya A, Hurlburt L, Cheng J, Thabane L, Tidy A, Murthy Y. Femoral nerve block improves analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials. Anesthesiology. 2010 Nov;113(5):1144-62. doi: 10.1097/ALN.0b013e3181f4b18. Review.
- Schroer WC, Diesfeld PG, LeMarr AR, Morton DJ, Reedy ME. Does Extended-Release Liposomal Bupivacaine Better Control Pain Than Bupivacaine After Total Knee Arthroplasty (TKA)? A Prospective, Randomized Clinical Trial. J Arthroplasty. 2015 Sep;30(9 Suppl):64-7. doi: 10.1016/j.arth.2015.01.059. Epub 2015 Jun 3.
- Wang C, Cai XZ, Yan SG. Comparison of Periarticular Multimodal Drug Injection and Femoral Nerve Block for Postoperative Pain Management in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2015 Jul;30(7):1281-6. doi: 10.1016/j.arth.2015.02.005. Epub 2015 Feb 20. Review.
Responsible Party:
Jeffrey Geller,
Associate Professor of Orthopedic Surgery at the Columbia University Medical Center,
Columbia University
ClinicalTrials.gov Identifier:
NCT02777749
Other Study ID Numbers:
- AAAQ0850
First Posted:
May 19, 2016
Last Update Posted:
Mar 20, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Adductor Canal Block | Periarticular SB | ACB + SB |
|---|---|---|---|
| Arm/Group Description | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. Adductor Canal Block (ACB) Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection | 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection |
| Period Title: Overall Study | |||
| STARTED | 53 | 51 | 51 |
| COMPLETED | 53 | 51 | 51 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Adductor Canal Block | Periarticular SB | ACB + SB | Total |
|---|---|---|---|---|
| Arm/Group Description | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. Adductor Canal Block (ACB) Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection | 20 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 20 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection | Total of all reporting groups |
| Overall Participants | 53 | 51 | 51 | 155 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
14
26.4%
|
9
17.6%
|
13
25.5%
|
36
23.2%
|
| >=65 years |
39
73.6%
|
42
82.4%
|
38
74.5%
|
119
76.8%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
69
(10)
|
73
(10)
|
71
(10)
|
71
(10)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
38
71.7%
|
33
64.7%
|
37
72.5%
|
108
69.7%
|
| Male |
15
28.3%
|
18
35.3%
|
14
27.5%
|
47
30.3%
|
| Race and Ethnicity Not Collected (Count of Participants) | ||||
| Count of Participants [Participants] |
0
0%
|
|||
Outcome Measures
| Title | Change in VAS Pain Scores |
|---|---|
| Description | Post-operatively, visual analog scale (VAS) pain scores will be recorded two times/day from Post-Operative Day (POD) 0 through POD3. VAS Scores range from 0 to 10, with 0 being "No Pain" and 10 being the "Worst Pain" |
| Time Frame | Day 0 through Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Adductor Canal Block | Periarticular SB | ACB + SB |
|---|---|---|---|
| Arm/Group Description | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. Adductor Canal Block (ACB) Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection | 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection |
| Measure Participants | 53 | 51 | 51 |
| Day 0 |
3.0
(2.9)
|
3.0
(3.0)
|
2.7
(2.6)
|
| Day 1 |
3.9
(2.3)
|
3.8
(2.4)
|
3.0
(2.1)
|
| Day 2 |
4.1
(2.5)
|
3.8
(2.4)
|
3.3
(2.5)
|
| Day 3 |
4.2
(3.1)
|
3.0
(2.8)
|
2.0
(2.0)
|
| Title | Change in Activity Level |
|---|---|
| Description | Daily steps taken will be recorded. The more steps taken daily the better. Minimum is 0 steps, maximum is unlimited. |
| Time Frame | Day 0 and Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Adductor Canal Block | Periarticular SB | ACB + SB |
|---|---|---|---|
| Arm/Group Description | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. Adductor Canal Block (ACB) Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection | 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection |
| Measure Participants | 53 | 51 | 51 |
| Day 0 |
26
(33)
|
68
(63)
|
65
(50)
|
| Day 1 |
124
(117)
|
120
(117)
|
139
(118)
|
| Title | Opioid Consumption |
|---|---|
| Description | Total amount of opioid consumption post-operatively will be recorded. The less opioids consumed (mg) postoperatively the better. A morphine equivalence metric will be used for equianalgesic comparison. Minimum is 0 mg, maximum is unlimited. |
| Time Frame | Day 0 through Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Adductor Canal Block | Periarticular SB | ACB + SB |
|---|---|---|---|
| Arm/Group Description | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. Adductor Canal Block (ACB) Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection | 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection |
| Measure Participants | 53 | 51 | 51 |
| Combined (POD0 through POD3) |
131
(74)
|
100
(62)
|
98
(62)
|
| POD0 |
33
(15)
|
31
(18)
|
35
(21)
|
| POD1 |
48
(25)
|
42
(31)
|
40
(30)
|
| POD2 |
35
(29)
|
20
(22)
|
18
(21)
|
| POD3 |
13
(23)
|
5.5
(16)
|
4.3
(9)
|
| Title | Range of Knee Flexion |
|---|---|
| Description | Range of knee flexion for active motion will be recorded at 3 week follow-up for all groups. The greater range of motion the better, with a good outcome considered at least 115 degrees of motion. |
| Time Frame | Postoperative day 21 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Adductor Canal Block | Periarticular SB | ACB + SB |
|---|---|---|---|
| Arm/Group Description | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. Adductor Canal Block (ACB) Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection | 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection |
| Measure Participants | 53 | 51 | 51 |
| Mean (Standard Deviation) [degrees] |
99
(15)
|
104
(12)
|
101
(16)
|
| Title | Length of Hospital Stay |
|---|---|
| Description | Total length of hospital stay from time of surgery through time of discharge will be recorded. The shorter the length of stay (days) the better. Range 0 days to 5 days. |
| Time Frame | Up to Day 5 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Adductor Canal Block | Periarticular SB | ACB + SB |
|---|---|---|---|
| Arm/Group Description | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. Adductor Canal Block (ACB) Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection | 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or50 cc's short-acting bupivacaine (SB), intramuscular injection |
| Measure Participants | 53 | 51 | 51 |
| Mean (Standard Deviation) [days] |
2.9
(1.5)
|
2.5
(1.2)
|
2.5
(2.1)
|
Adverse Events
| Time Frame | postoperative day 0 through post-operative day 21. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | No serious adverse events, including mortality. This was a healthy cohort of patients undergoing elective surgery for total knee replacement. There were no expected adverse events. | |||||
| Arm/Group Title | Adductor Canal Block | Periarticular SB | ACB + SB | |||
| Arm/Group Description | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. Adductor Canal Block (ACB) Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection | 50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection | 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon. Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection | |||
All Cause Mortality |
||||||
| Adductor Canal Block | Periarticular SB | ACB + SB | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/53 (0%) | 0/51 (0%) | 0/51 (0%) | |||
Serious Adverse Events |
||||||
| Adductor Canal Block | Periarticular SB | ACB + SB | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/53 (0%) | 0/51 (0%) | 0/51 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Adductor Canal Block | Periarticular SB | ACB + SB | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/53 (0%) | 0/51 (0%) | 0/51 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT 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 | Dr. Matthew Grosso |
|---|---|
| Organization | Columbia University Medical Center |
| Phone | 2123058193 |
| mgrosso13@gmail.com |
Responsible Party:
Jeffrey Geller,
Associate Professor of Orthopedic Surgery at the Columbia University Medical Center,
Columbia University
ClinicalTrials.gov Identifier:
NCT02777749
Other Study ID Numbers:
- AAAQ0850
First Posted:
May 19, 2016
Last Update Posted:
Mar 20, 2019
Last Verified:
Mar 1, 2019