Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular
Study Details
Study Description
Brief Summary
Total hip arthroplasty is a one of the most commonly performed surgical procedures with increasing numbers anticipated over the next several decades. The purpose of this study was to find a better way to make patients comfortable after their hip surgery. Three different ways of providing pain relief were compared, a peripheral nerve block in the lower back outside of the spinal space (using bupivacaine, a numbing medicine), or injections around the hip joint with one of two different medicines, either Ropivacaine or Liposomal Bupivacaine (Exparel®).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
Total hip arthroplasty is associated with moderate to severe postoperative pain and an ideal clinical pathway for pain management has yet to be established. Multimodal pain management incorporating the use of regional anesthesia for THA has led to decreased hospital length of stay, improved patient comfort, and enhanced patient satisfaction that is efficacious and cost-effective. This investigation compared multimodal total joint arthroplasty pathways with continuous lumbar plexus blockade versus two different periarticular injection mixtures to potentially determine an ideal perioperative analgesia pathway for THA.
Patients undergoing elective, unilateral primary total hip arthroplasty within a clinical pathway utilizing preemptive low-dose opioid and non-opioid medications for multimodal analgesia were randomized to one of three different intervention groups after informed consent was obtained: posterior lumbar plexus block (PNB), periarticular infiltration (PAI) with ropivacaine, ketorolac, and epinephrine, and PAI with liposomal bupivacaine, ketorolac, and epinephrine. The investigators hypothesized differences in the analgesia outcomes between the three intervention groups would provide for an evidenced-based clinical pathway to emerge as a result of this study.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: PNB Bupivacaine Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival. |
Drug: PNB Bupivacaine
Infusion
Other Names:
Drug: Epinephrine
Injection, weight-based dosage of 100 mcg - 300 mcg
|
Active Comparator: PAI Ropivacaine Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg. |
Drug: PAI Ropivacaine
Injection
Other Names:
Drug: Epinephrine
Injection, weight-based dosage of 100 mcg - 300 mcg
Drug: Ketorolac
Injection, 30 mg
Other Names:
|
Active Comparator: PAI liposomal bupivacaine Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. |
Drug: PAI liposomal bupivacaine
Injection
Other Names:
Drug: Epinephrine
Injection, weight-based dosage of 100 mcg - 300 mcg
Drug: Ketorolac
Injection, 30 mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum Postoperative Pain Score [Post-Operative Day 1 (0600-1200)]
Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.
Secondary Outcome Measures
- Total Opioid Consumption During Hospitalization [Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2]
Measured in daily oral morphine equivalents (OME)
Other Outcome Measures
- Hospital Length of Stay [Post-operative Day 1 through discharge (approximately 3 days)]
Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions.
- Change in Unipedal Stance Time [Baseline, 3 months]
Length of time in seconds a patient could stand on involved leg
- Post-Operative Pain Score [3 month follow-up]
Pain intensity (NRS) assessment at 3 month follow-up. Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.
- Change in Short Form-36 (SF-36) Quality of Life Physical Component [Baseline, 3 months]
Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).
- Change in Short Form-36 (SF-36) Quality of Life Mental Component [Baseline, 3 months]
Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).
- Number of Participants Reporting Complications Since Surgery [Post-operative Day 1 Through 3 - Month Follow-up]
Complications were collected by telephone interview after surgery.
- Number of Participants Reporting a NRS Pain Score Greater Than 3 [3 month follow up]
Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
-
Patients presenting for unilateral primary total hip arthroplasty
-
Patients 18 years of age and older
Exclusion Criteria:
-
Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
-
History of long term use of daily opioids (>1 months) with Oral Morphine Equivalent (OME) >5mg/day
-
Body mass index (BMI) > 40 kg/m2
-
Allergies to medications used in this study such as: fentanyl,hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, tramadol, ondansetron, droperidol, dexamethasone, celecoxib and OxyContin
-
Major systemic medical problems such as:
-
severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2
-
cardiovascular disorders defined as Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV
-
severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver
-
Impaired cognitive function or inability to understand the study protocol
-
Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy in the operative extremity, coagulopathy [platelets < 100,000, International Normalized Ratio (INR) >1.5], refusal, etc.).
-
Previous contralateral hip replacement managed with regional or periarticular injection
-
Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
-
Pregnancy or breastfeeding (women of child-bearing potential will require a negative pregnancy test)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Rebecca Johnson, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 14-004183
- UL1TR000135
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine |
---|---|---|---|
Arm/Group Description | Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival. Posterior lumbar plexus block (PNB) Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg | Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg. Periarticular infiltration (PAI) Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg |
Period Title: Overall Study | |||
STARTED | 55 | 55 | 55 |
COMPLETED | 51 | 54 | 54 |
NOT COMPLETED | 4 | 1 | 1 |
Baseline Characteristics
Arm/Group Title | PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine | Total |
---|---|---|---|---|
Arm/Group Description | Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg | Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | Total of all reporting groups |
Overall Participants | 51 | 54 | 54 | 159 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
62.1
(11.5)
|
59.4
(15.3)
|
61.7
(11.7)
|
61.0
(12.9)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
25
49%
|
27
50%
|
28
51.9%
|
80
50.3%
|
Male |
26
51%
|
27
50%
|
26
48.1%
|
79
49.7%
|
Race and Ethnicity Not Collected (Count of Participants) | ||||
Count of Participants [Participants] |
0
0%
|
|||
Region of Enrollment (participants) [Number] | ||||
United States |
51
100%
|
54
100%
|
54
100%
|
159
100%
|
Duration of surgery (minutes) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [minutes] |
91.4
(24.0)
|
88.1
(23.2)
|
88.4
(28.3)
|
89.2
(25.2)
|
Type of anesthetic (Count of Participants) | ||||
General |
13
25.5%
|
10
18.5%
|
13
24.1%
|
36
22.6%
|
Spinal |
38
74.5%
|
44
81.5%
|
41
75.9%
|
123
77.4%
|
American Society of Anesthesiologists (ASA) Status (Count of Participants) | ||||
I or II |
44
86.3%
|
41
75.9%
|
45
83.3%
|
130
81.8%
|
III |
7
13.7%
|
13
24.1%
|
9
16.7%
|
29
18.2%
|
BMI (kg/m2) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [kg/m2] |
30.0
(6.0)
|
30.1
(6.0)
|
30.2
(5.4)
|
30.1
(5.8)
|
Outcome Measures
Title | Maximum Postoperative Pain Score |
---|---|
Description | Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain. |
Time Frame | Post-Operative Day 1 (0600-1200) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine |
---|---|---|---|
Arm/Group Description | Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg | Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg |
Measure Participants | 51 | 54 | 54 |
Median (Inter-Quartile Range) [units on a scale] |
3.0
|
4.0
|
3.0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.033 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.662 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.103 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Title | Total Opioid Consumption During Hospitalization |
---|---|
Description | Measured in daily oral morphine equivalents (OME) |
Time Frame | Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2 |
Outcome Measure Data
Analysis Population Description |
---|
For Post Operative Day (POD) 2, data were missing for 26 subjects (7 in the PNB group, 9 in the PAI-R group, and 10 in the PAI-L group). |
Arm/Group Title | PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine |
---|---|---|---|
Arm/Group Description | Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg | Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg |
Measure Participants | 51 | 54 | 54 |
Preoperative |
15
|
15
|
15
|
Intraoperative |
10
|
10
|
10
|
Postanesthesia Care Unit (PACU) |
0
|
0
|
0
|
Post Operative Day (POD) 0 post PACU |
7.5
|
15
|
11.3
|
POD 1 |
22.5
|
33.8
|
15
|
POD 2 |
15
|
15
|
11.3
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine |
---|---|---|
Comments | Preoperative | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.948 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | Preoperative | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.880 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | Preoperative | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.802 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine |
---|---|---|
Comments | Intraoperative | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.179 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | Intraoperative | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.837 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | Intraoperative | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.142 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine |
---|---|---|
Comments | PACU | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.010 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | PACU | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.516 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | PACU | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.052 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine |
---|---|---|
Comments | POD 0 post PACU | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.840 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | POD 0 post PACU | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.744 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | POD 0 post PACU | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.501 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine |
---|---|---|
Comments | POD 1 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.358 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | POD 1 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.536 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | POD 1 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.110 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine |
---|---|---|
Comments | POD 2 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.313 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | POD 2 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.893 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | POD 2 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.232 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Title | Hospital Length of Stay |
---|---|
Description | Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions. |
Time Frame | Post-operative Day 1 through discharge (approximately 3 days) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine |
---|---|---|---|
Arm/Group Description | Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg | Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg |
Measure Participants | 51 | 54 | 54 |
Median (Inter-Quartile Range) [days] |
2
|
2
|
2
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.772 |
Comments | ||
Method | Kruskal-Wallis | |
Comments |
Title | Change in Unipedal Stance Time |
---|---|
Description | Length of time in seconds a patient could stand on involved leg |
Time Frame | Baseline, 3 months |
Outcome Measure Data
Analysis Population Description |
---|
Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively. |
Arm/Group Title | PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine |
---|---|---|---|
Arm/Group Description | Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg | Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg |
Measure Participants | 50 | 54 | 51 |
Baseline |
24.5
|
30
|
30
|
3 months |
30
|
30
|
30
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | Baseline | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.251 |
Comments | ||
Method | Regression, Cox | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | 3 month follow-up | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.300 |
Comments | ||
Method | Regression, Cox | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine |
---|---|---|
Comments | Baseline vs 3 months | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.113 |
Comments | ||
Method | Regression, Cox | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | PAI Ropivacaine |
---|---|---|
Comments | Baseline vs 3 months | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.147 |
Comments | ||
Method | Regression, Cox | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | PAI Liposomal Bupivacaine |
---|---|---|
Comments | Baseline vs 3 months | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.216 |
Comments | ||
Method | Regression, Cox | |
Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | Baseline vs 3 months | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.968 |
Comments | ||
Method | Regression, Cox | |
Comments |
Title | Post-Operative Pain Score |
---|---|
Description | Pain intensity (NRS) assessment at 3 month follow-up. Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain. |
Time Frame | 3 month follow-up |
Outcome Measure Data
Analysis Population Description |
---|
Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively. |
Arm/Group Title | PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine |
---|---|---|---|
Arm/Group Description | Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg | Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg |
Measure Participants | 50 | 54 | 51 |
Pain at rest |
0
|
0
|
0
|
Pain with movement |
0
|
1
|
1
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | Pain at rest | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.776 |
Comments | ||
Method | Kruskal-Wallis | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | Pain with movement | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.447 |
Comments | ||
Method | Kruskal-Wallis | |
Comments |
Title | Change in Short Form-36 (SF-36) Quality of Life Physical Component |
---|---|
Description | Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable). |
Time Frame | Baseline, 3 months |
Outcome Measure Data
Analysis Population Description |
---|
Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively. |
Arm/Group Title | PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine |
---|---|---|---|
Arm/Group Description | Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg | Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg |
Measure Participants | 50 | 52 | 51 |
Mean (Standard Deviation) [units on a scale] |
12.5
(10.3)
|
12.6
(9.1)
|
12.3
(8.8)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.986 |
Comments | ||
Method | ANOVA | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine |
---|---|---|
Comments | Baseline vs 3 months | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | t-test, 1 sided | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | PAI Ropivacaine |
---|---|---|
Comments | Baseline vs 3 months | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | t-test, 1 sided | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | PAI Liposomal Bupivacaine |
---|---|---|
Comments | Baseline vs 3 months | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | t-test, 1 sided | |
Comments |
Title | Change in Short Form-36 (SF-36) Quality of Life Mental Component |
---|---|
Description | Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable). |
Time Frame | Baseline, 3 months |
Outcome Measure Data
Analysis Population Description |
---|
Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively. |
Arm/Group Title | PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine |
---|---|---|---|
Arm/Group Description | Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg | Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg |
Measure Participants | 50 | 52 | 51 |
Mean (Standard Deviation) [units on a scale] |
2.2
(9.5)
|
2.6
(9.4)
|
3.0
(9.4)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.898 |
Comments | ||
Method | ANOVA | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine |
---|---|---|
Comments | Baseline vs 3 months | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.112 |
Comments | ||
Method | t-test, 1 sided | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | PAI Ropivacaine |
---|---|---|
Comments | Baseline vs 3 months | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.046 |
Comments | ||
Method | t-test, 1 sided | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | PAI Liposomal Bupivacaine |
---|---|---|
Comments | Baseline vs 3 months | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.026 |
Comments | ||
Method | t-test, 1 sided | |
Comments |
Title | Number of Participants Reporting Complications Since Surgery |
---|---|
Description | Complications were collected by telephone interview after surgery. |
Time Frame | Post-operative Day 1 Through 3 - Month Follow-up |
Outcome Measure Data
Analysis Population Description |
---|
Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively. |
Arm/Group Title | PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine |
---|---|---|---|
Arm/Group Description | Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg | Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg |
Measure Participants | 50 | 54 | 51 |
Operative extremity neurologic changes |
1
2%
|
1
1.9%
|
2
3.7%
|
Wound infection |
0
0%
|
1
1.9%
|
1
1.9%
|
Fall requiring medical attention |
1
2%
|
2
3.7%
|
1
1.9%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | Operative extremity neurologic changes | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.843 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | Wound infection | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 1.00 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | Fall requiring medical attention | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 1.00 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Number of Participants Reporting a NRS Pain Score Greater Than 3 |
---|---|
Description | Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain. |
Time Frame | 3 month follow up |
Outcome Measure Data
Analysis Population Description |
---|
Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively. |
Arm/Group Title | PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine |
---|---|---|---|
Arm/Group Description | Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg | Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg |
Measure Participants | 50 | 54 | 51 |
Pain at rest |
0
0%
|
1
1.9%
|
1
1.9%
|
Pain with movement |
0
0%
|
4
7.4%
|
2
3.7%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | Pain at rest | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 1.00 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | PNB Bupivacaine, PAI Ropivacaine, PAI Liposomal Bupivacaine |
---|---|---|
Comments | Pain with movement | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.167 |
Comments | ||
Method | Fisher Exact | |
Comments |
Adverse Events
Time Frame | Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant. | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | The Anesthesia Clinical Research Unit (ACRU) not affiliated with the investigator team had continuous access to information regarding adverse outcomes and monitored quarterly reporting to the principal investigator. Participants were postoperatively monitored for adverse outcomes by the inpatient pain service (IPS) or surgical team. | |||||
Arm/Group Title | PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine | |||
Arm/Group Description | Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival. PNB Bupivacaine: Infusion Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg | Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg. PAI Ropivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. PAI liposomal bupivacaine: Injection Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg Ketorolac: Injection, 30 mg | |||
All Cause Mortality |
||||||
PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/51 (0%) | 0/54 (0%) | 0/54 (0%) | |||
Serious Adverse Events |
||||||
PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/51 (0%) | 0/54 (0%) | 0/54 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
PNB Bupivacaine | PAI Ropivacaine | PAI Liposomal Bupivacaine | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/51 (0%) | 3/54 (5.6%) | 1/54 (1.9%) | |||
General disorders | ||||||
Fall | 0/51 (0%) | 0 | 0/54 (0%) | 0 | 0/54 (0%) | 0 |
Infection | 0/51 (0%) | 0 | 0/54 (0%) | 0 | 0/54 (0%) | 0 |
ICU admission | 0/51 (0%) | 0 | 3/54 (5.6%) | 3 | 0/54 (0%) | 0 |
Rapid response team | 0/51 (0%) | 0 | 2/54 (3.7%) | 2 | 0/54 (0%) | 0 |
Nervous system disorders | ||||||
Nerve Injury | 0/51 (0%) | 0 | 0/54 (0%) | 0 | 0/54 (0%) | 0 |
Surgical and medical procedures | ||||||
Additional surgery | 0/51 (0%) | 0 | 0/54 (0%) | 0 | 1/54 (1.9%) | 1 |
Limitations/Caveats
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 | Dr. Rebecca L. Johnson |
---|---|
Organization | Mayo Clinic |
Phone | 507-266-2049 |
Johnson.Rebecca1@mayo.edu |
- 14-004183
- UL1TR000135