Trial Outcomes & Findings for Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular (NCT NCT02242201)
NCT ID: NCT02242201
Last Updated: 2018-04-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
165 participants
Primary outcome timeframe
Post-Operative Day 1 (0600-1200)
Results posted on
2018-04-19
Participant Flow
Participant milestones
| Measure |
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.
Posterior lumbar plexus block (PNB) Bupivacaine: Infusion
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg
|
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.
Periarticular infiltration (PAI) Ropivacaine: Injection
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg
Ketorolac: Injection, 30 mg
|
PAI Liposomal Bupivacaine
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
55
|
|
Overall Study
COMPLETED
|
51
|
54
|
54
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
Posterior lumbar plexus block (PNB) Bupivacaine: Infusion
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg
|
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.
Periarticular infiltration (PAI) Ropivacaine: Injection
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg
Ketorolac: Injection, 30 mg
|
PAI Liposomal Bupivacaine
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
|
|---|---|---|---|
|
Overall Study
preoperative identified neuropathy
|
2
|
0
|
0
|
|
Overall Study
planned post-op anticoagulation
|
1
|
0
|
0
|
|
Overall Study
changed surgical procedure
|
1
|
0
|
0
|
|
Overall Study
postponed surgery
|
0
|
0
|
1
|
|
Overall Study
preoperative opioid consumption
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PNB Bupivacaine
n=51 Participants
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
|
PAI Ropivacaine
n=54 Participants
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
|
PAI Liposomal Bupivacaine
n=54 Participants
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
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 11.5 • n=51 Participants
|
59.4 years
STANDARD_DEVIATION 15.3 • n=54 Participants
|
61.7 years
STANDARD_DEVIATION 11.7 • n=54 Participants
|
61.0 years
STANDARD_DEVIATION 12.9 • n=159 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=51 Participants
|
27 Participants
n=54 Participants
|
28 Participants
n=54 Participants
|
80 Participants
n=159 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=51 Participants
|
27 Participants
n=54 Participants
|
26 Participants
n=54 Participants
|
79 Participants
n=159 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
51 participants
n=51 Participants
|
54 participants
n=54 Participants
|
54 participants
n=54 Participants
|
159 participants
n=159 Participants
|
|
Duration of surgery
|
91.4 minutes
STANDARD_DEVIATION 24.0 • n=51 Participants
|
88.1 minutes
STANDARD_DEVIATION 23.2 • n=54 Participants
|
88.4 minutes
STANDARD_DEVIATION 28.3 • n=54 Participants
|
89.2 minutes
STANDARD_DEVIATION 25.2 • n=159 Participants
|
|
Type of anesthetic
General
|
13 Participants
n=51 Participants
|
10 Participants
n=54 Participants
|
13 Participants
n=54 Participants
|
36 Participants
n=159 Participants
|
|
Type of anesthetic
Spinal
|
38 Participants
n=51 Participants
|
44 Participants
n=54 Participants
|
41 Participants
n=54 Participants
|
123 Participants
n=159 Participants
|
|
American Society of Anesthesiologists (ASA) Status
I or II
|
44 Participants
n=51 Participants
|
41 Participants
n=54 Participants
|
45 Participants
n=54 Participants
|
130 Participants
n=159 Participants
|
|
American Society of Anesthesiologists (ASA) Status
III
|
7 Participants
n=51 Participants
|
13 Participants
n=54 Participants
|
9 Participants
n=54 Participants
|
29 Participants
n=159 Participants
|
|
BMI
|
30.0 kg/m2
STANDARD_DEVIATION 6.0 • n=51 Participants
|
30.1 kg/m2
STANDARD_DEVIATION 6.0 • n=54 Participants
|
30.2 kg/m2
STANDARD_DEVIATION 5.4 • n=54 Participants
|
30.1 kg/m2
STANDARD_DEVIATION 5.8 • n=159 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PAI Ropivacaine
n=54 Participants
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
|
PAI Liposomal Bupivacaine
n=54 Participants
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
|
PNB Bupivacaine
n=51 Participants
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
|
|---|---|---|---|
|
Maximum Postoperative Pain Score
|
4.0 units on a scale
Interval 2.0 to 5.0
|
3.0 units on a scale
Interval 2.0 to 5.0
|
3.0 units on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2Population: 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).
Measured in daily oral morphine equivalents (OME)
Outcome measures
| Measure |
PAI Ropivacaine
n=54 Participants
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
|
PAI Liposomal Bupivacaine
n=54 Participants
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
|
PNB Bupivacaine
n=51 Participants
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
|
|---|---|---|---|
|
Total Opioid Consumption During Hospitalization
Preoperative
|
15 Oral morphine equivalent in milligrams
Interval 0.0 to 30.0
|
15 Oral morphine equivalent in milligrams
Interval 15.0 to 30.0
|
15 Oral morphine equivalent in milligrams
Interval 0.0 to 30.0
|
|
Total Opioid Consumption During Hospitalization
Postanesthesia Care Unit (PACU)
|
0 Oral morphine equivalent in milligrams
Interval 0.0 to 0.0
|
0 Oral morphine equivalent in milligrams
Interval 0.0 to 10.0
|
0 Oral morphine equivalent in milligrams
Interval 0.0 to 10.0
|
|
Total Opioid Consumption During Hospitalization
Intraoperative
|
10 Oral morphine equivalent in milligrams
Interval 5.0 to 15.0
|
10 Oral morphine equivalent in milligrams
Interval 5.0 to 20.0
|
10 Oral morphine equivalent in milligrams
Interval 5.0 to 20.0
|
|
Total Opioid Consumption During Hospitalization
Post Operative Day (POD) 0 post PACU
|
15 Oral morphine equivalent in milligrams
Interval 0.0 to 30.0
|
11.3 Oral morphine equivalent in milligrams
Interval 0.0 to 22.5
|
7.5 Oral morphine equivalent in milligrams
Interval 0.0 to 30.0
|
|
Total Opioid Consumption During Hospitalization
POD 1
|
33.8 Oral morphine equivalent in milligrams
Interval 7.5 to 60.0
|
15 Oral morphine equivalent in milligrams
Interval 7.5 to 45.0
|
22.5 Oral morphine equivalent in milligrams
Interval 7.5 to 60.0
|
|
Total Opioid Consumption During Hospitalization
POD 2
|
15 Oral morphine equivalent in milligrams
Interval 0.0 to 45.0
|
11.3 Oral morphine equivalent in milligrams
Interval 0.0 to 18.8
|
15 Oral morphine equivalent in milligrams
Interval 0.0 to 30.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-operative Day 1 through discharge (approximately 3 days)Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions.
Outcome measures
| Measure |
PAI Ropivacaine
n=54 Participants
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
|
PAI Liposomal Bupivacaine
n=54 Participants
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
|
PNB Bupivacaine
n=51 Participants
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
|
|---|---|---|---|
|
Hospital Length of Stay
|
2 days
Interval 2.0 to 3.0
|
2 days
Interval 2.0 to 2.0
|
2 days
Interval 2.0 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 monthsPopulation: Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
Length of time in seconds a patient could stand on involved leg
Outcome measures
| Measure |
PAI Ropivacaine
n=54 Participants
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
|
PAI Liposomal Bupivacaine
n=51 Participants
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
|
PNB Bupivacaine
n=50 Participants
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
|
|---|---|---|---|
|
Change in Unipedal Stance Time
Baseline
|
30 seconds
Interval 9.0 to 30.0
|
30 seconds
Interval 7.0 to 30.0
|
24.5 seconds
Interval 6.0 to 30.0
|
|
Change in Unipedal Stance Time
3 months
|
30 seconds
Interval 18.0 to 30.0
|
30 seconds
Interval 15.0 to 30.0
|
30 seconds
Interval 12.0 to 30.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 month follow-upPopulation: Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
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.
Outcome measures
| Measure |
PAI Ropivacaine
n=54 Participants
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
|
PAI Liposomal Bupivacaine
n=51 Participants
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
|
PNB Bupivacaine
n=50 Participants
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
|
|---|---|---|---|
|
Post-Operative Pain Score
Pain at rest
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Post-Operative Pain Score
Pain with movement
|
1 units on a scale
Interval 0.0 to 2.0
|
1 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 monthsPopulation: Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
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).
Outcome measures
| Measure |
PAI Ropivacaine
n=52 Participants
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
|
PAI Liposomal Bupivacaine
n=51 Participants
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
|
PNB Bupivacaine
n=50 Participants
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
|
|---|---|---|---|
|
Change in Short Form-36 (SF-36) Quality of Life Physical Component
|
12.6 units on a scale
Standard Deviation 9.1
|
12.3 units on a scale
Standard Deviation 8.8
|
12.5 units on a scale
Standard Deviation 10.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 monthsPopulation: Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
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).
Outcome measures
| Measure |
PAI Ropivacaine
n=52 Participants
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
|
PAI Liposomal Bupivacaine
n=51 Participants
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
|
PNB Bupivacaine
n=50 Participants
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
|
|---|---|---|---|
|
Change in Short Form-36 (SF-36) Quality of Life Mental Component
|
2.6 units on a scale
Standard Deviation 9.4
|
3.0 units on a scale
Standard Deviation 9.4
|
2.2 units on a scale
Standard Deviation 9.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-operative Day 1 Through 3 - Month Follow-upPopulation: Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
Complications were collected by telephone interview after surgery.
Outcome measures
| Measure |
PAI Ropivacaine
n=54 Participants
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
|
PAI Liposomal Bupivacaine
n=51 Participants
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
|
PNB Bupivacaine
n=50 Participants
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
|
|---|---|---|---|
|
Number of Participants Reporting Complications Since Surgery
Operative extremity neurologic changes
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Complications Since Surgery
Wound infection
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Complications Since Surgery
Fall requiring medical attention
|
2 Participants
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 month follow upPopulation: Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.
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.
Outcome measures
| Measure |
PAI Ropivacaine
n=54 Participants
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
|
PAI Liposomal Bupivacaine
n=51 Participants
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
|
PNB Bupivacaine
n=50 Participants
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
|
|---|---|---|---|
|
Number of Participants Reporting a NRS Pain Score Greater Than 3
Pain at rest
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a NRS Pain Score Greater Than 3
Pain with movement
|
4 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
PNB Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PAI Ropivacaine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PAI Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PNB Bupivacaine
n=51 participants at risk
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
|
PAI Ropivacaine
n=54 participants at risk
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
|
PAI Liposomal Bupivacaine
n=54 participants at risk
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
|
|---|---|---|---|
|
General disorders
Fall
|
0.00%
0/51 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
0.00%
0/54 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
0.00%
0/54 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
|
Nervous system disorders
Nerve Injury
|
0.00%
0/51 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
0.00%
0/54 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
0.00%
0/54 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
|
General disorders
Infection
|
0.00%
0/51 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
0.00%
0/54 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
0.00%
0/54 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
|
General disorders
ICU admission
|
0.00%
0/51 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
5.6%
3/54 • Number of events 3 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
0.00%
0/54 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
|
General disorders
Rapid response team
|
0.00%
0/51 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
3.7%
2/54 • Number of events 2 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
0.00%
0/54 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
|
Surgical and medical procedures
Additional surgery
|
0.00%
0/51 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
0.00%
0/54 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
1.9%
1/54 • Number of events 1 • Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place