Trial Outcomes & Findings for Intraoperative Liposomal Bupivacaine vs. Bupivacaine for Total Hip Replacement Pain Management (NCT NCT03001453)
NCT ID: NCT03001453
Last Updated: 2018-07-26
Results Overview
All opioid doses were administered to the patient at 12-hour intervals post-surgery. Doses were recorded till either of the following criteria was met, the patient was discharged or the 72-hour post-surgery timeframe ended. The doses were then collected and converted to OMEs, in milligrams.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
72 hours postoperation, divided into six 12-hour periods
Results posted on
2018-07-26
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine
Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine
Liposomal Bupivacaine: 266mg liposomal bupivacaine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
Saline: Normal saline
|
Bupivacaine With Epinephrine
Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
57
|
|
Overall Study
COMPLETED
|
50
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine
n=50 Participants
Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine
Liposomal Bupivacaine: 266mg liposomal bupivacaine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
Saline: Normal saline
|
Bupivacaine With Epinephrine
n=57 Participants
Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.9 years
n=50 Participants
|
62.4 years
n=57 Participants
|
62.1 years
n=107 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=50 Participants
|
26 Participants
n=57 Participants
|
55 Participants
n=107 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=50 Participants
|
31 Participants
n=57 Participants
|
52 Participants
n=107 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index
|
29.2 kg/m^2
n=50 Participants
|
31 kg/m^2
n=57 Participants
|
30.1 kg/m^2
n=107 Participants
|
|
Laterality
Left
|
19 hips
n=50 Participants
|
30 hips
n=57 Participants
|
49 hips
n=107 Participants
|
|
Laterality
Right
|
31 hips
n=50 Participants
|
27 hips
n=57 Participants
|
58 hips
n=107 Participants
|
|
Robotic assistance
|
42 Participants
n=50 Participants
|
44 Participants
n=57 Participants
|
86 Participants
n=107 Participants
|
|
Preoperative opioid prescription
Codeine
|
1 Participants
n=50 Participants
|
0 Participants
n=57 Participants
|
1 Participants
n=107 Participants
|
|
Preoperative opioid prescription
Hydrocodone
|
5 Participants
n=50 Participants
|
7 Participants
n=57 Participants
|
12 Participants
n=107 Participants
|
|
Preoperative opioid prescription
Hydromorphine
|
0 Participants
n=50 Participants
|
1 Participants
n=57 Participants
|
1 Participants
n=107 Participants
|
|
Preoperative opioid prescription
Oxycodone
|
1 Participants
n=50 Participants
|
2 Participants
n=57 Participants
|
3 Participants
n=107 Participants
|
|
American Society of Anesthesiologists Grade
1
|
8 Participants
n=50 Participants
|
4 Participants
n=57 Participants
|
12 Participants
n=107 Participants
|
|
American Society of Anesthesiologists Grade
2
|
26 Participants
n=50 Participants
|
31 Participants
n=57 Participants
|
57 Participants
n=107 Participants
|
|
American Society of Anesthesiologists Grade
3
|
16 Participants
n=50 Participants
|
21 Participants
n=57 Participants
|
37 Participants
n=107 Participants
|
|
American Society of Anesthesiologists Grade
4
|
0 Participants
n=50 Participants
|
1 Participants
n=57 Participants
|
1 Participants
n=107 Participants
|
|
Exercise regularly
|
14 Participants
n=50 Participants
|
16 Participants
n=57 Participants
|
30 Participants
n=107 Participants
|
PRIMARY outcome
Timeframe: 72 hours postoperation, divided into six 12-hour periodsAll opioid doses were administered to the patient at 12-hour intervals post-surgery. Doses were recorded till either of the following criteria was met, the patient was discharged or the 72-hour post-surgery timeframe ended. The doses were then collected and converted to OMEs, in milligrams.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=50 Participants
Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine
Liposomal Bupivacaine: 266mg liposomal bupivacaine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
Saline: Normal saline
|
Bupivacaine With Epinephrine
n=57 Participants
Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
|
|---|---|---|
|
Patient Morphine Equivalent Consumption
0-12
|
35.1 mg
Standard Deviation 24.4
|
50.5 mg
Standard Deviation 34.5
|
|
Patient Morphine Equivalent Consumption
12-24
|
28.0 mg
Standard Deviation 17.4
|
29.6 mg
Standard Deviation 20.9
|
|
Patient Morphine Equivalent Consumption
24-36
|
16.8 mg
Standard Deviation 14.9
|
21.0 mg
Standard Deviation 20.2
|
|
Patient Morphine Equivalent Consumption
36-48
|
20.6 mg
Standard Deviation 17.0
|
27.4 mg
Standard Deviation 21.2
|
|
Patient Morphine Equivalent Consumption
48-60
|
23.7 mg
Standard Deviation 19.5
|
15.4 mg
Standard Deviation 19.0
|
|
Patient Morphine Equivalent Consumption
60-72
|
20.9 mg
Standard Deviation 19.6
|
20.7 mg
Standard Deviation 13.4
|
|
Patient Morphine Equivalent Consumption
Total
|
100.3 mg
Standard Deviation 74.3
|
121.2 mg
Standard Deviation 87.9
|
PRIMARY outcome
Timeframe: 72 hours post-operation, divided into six 12-hour periodsPatient-reported VAS pain intensity score (0 = no pain, 10 = worst pain possible) will be collected. Mean VAS scores for the 72-hour period were calculated using the cohort's reported average pain scores at each 12-hour interval.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=50 Participants
Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine
Liposomal Bupivacaine: 266mg liposomal bupivacaine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
Saline: Normal saline
|
Bupivacaine With Epinephrine
n=57 Participants
Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
|
|---|---|---|
|
Change in Patient-reported Visual Analog Scale (VAS) Pain Intensity Score
|
3.8 units on a scale
Standard Deviation 1.6
|
3.7 units on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: from time of surgery until patient first ambulates more than 20 feet or 72 hours post-surgery or patient discharge, whichever comes firstThe length of time (in hours) until the patient first ambulates more than 20 feet from the time of surgery will be recorded.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=50 Participants
Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine
Liposomal Bupivacaine: 266mg liposomal bupivacaine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
Saline: Normal saline
|
Bupivacaine With Epinephrine
n=57 Participants
Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
|
|---|---|---|
|
Time to Ambulation More Than 20 Feet (in Hours)
|
10.9 hours
Standard Deviation 8.8
|
14.0 hours
Standard Deviation 11.9
|
PRIMARY outcome
Timeframe: From time of surgery until patient is discharged, an average of 1.5 days.Outcome measures
| Measure |
Liposomal Bupivacaine
n=50 Participants
Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine
Liposomal Bupivacaine: 266mg liposomal bupivacaine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
Saline: Normal saline
|
Bupivacaine With Epinephrine
n=57 Participants
Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
|
|---|---|---|
|
Length of Stay (LOS, in Days)
|
46.0 Hours
Standard Deviation 26.2
|
44.4 Hours
Standard Deviation 27.1
|
PRIMARY outcome
Timeframe: 72 hours postoperationOutcome measures
| Measure |
Liposomal Bupivacaine
n=50 Participants
Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine
Liposomal Bupivacaine: 266mg liposomal bupivacaine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
Saline: Normal saline
|
Bupivacaine With Epinephrine
n=57 Participants
Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
|
|---|---|---|
|
Number of Patients That Experienced a Fall
|
0 participants
|
0 participants
|
Adverse Events
Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Bupivacaine With Epinephrine
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Liposomal Bupivacaine
n=50 participants at risk
Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine
Liposomal Bupivacaine: 266mg liposomal bupivacaine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
Saline: Normal saline
|
Bupivacaine With Epinephrine
n=57 participants at risk
Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine
0.25% Bupivacaine with epinephrine: 0.25% bupivacaine with epinephrine
|
|---|---|---|
|
General disorders
Constipation
|
8.0%
4/50
|
1.8%
1/57
|
|
General disorders
Nausea
|
16.0%
8/50
|
10.5%
6/57
|
|
General disorders
Vomiting
|
4.0%
2/50
|
7.0%
4/57
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place