Trial Outcomes & Findings for The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery (NCT NCT03196505)

NCT ID: NCT03196505

Last Updated: 2020-11-25

Results Overview

in hospital total oral and IV morphine equivalents required after laparoscopic bariatric surgery.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 231 participants
• Primary outcome timeframe: within 1 week post-operatively
• Results posted on: 2020-11-25

Participant Flow

Participant milestones

Measure	Liposomal Bupivacaine Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Exparel 266 MG Per 20 ML Injection: Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).	Control 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Bupivacaine: 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
Overall Study STARTED	115	116
Overall Study COMPLETED	89	90
Overall Study NOT COMPLETED	26	26

Reasons for withdrawal

Measure	Liposomal Bupivacaine Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Exparel 266 MG Per 20 ML Injection: Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).	Control 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Bupivacaine: 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
Overall Study Physician Decision	26	26

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Liposomal Bupivacaine n=89 Participants Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Exparel 266 MG Per 20 ML Injection: Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).	Control n=90 Participants 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Bupivacaine: 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).	Total n=179 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=89 Participants	0 Participants n=90 Participants	0 Participants n=179 Participants
Age, Categorical Between 18 and 65 years	89 Participants n=89 Participants	90 Participants n=90 Participants	179 Participants n=179 Participants
Age, Categorical >=65 years	0 Participants n=89 Participants	0 Participants n=90 Participants	0 Participants n=179 Participants
Age, Continuous	39.2 years STANDARD_DEVIATION 9.8 • n=89 Participants	39.2 years STANDARD_DEVIATION 10.1 • n=90 Participants	39.2 years STANDARD_DEVIATION 9.9 • n=179 Participants
Sex: Female, Male Female	68 Participants n=89 Participants	74 Participants n=90 Participants	142 Participants n=179 Participants
Sex: Female, Male Male	21 Participants n=89 Participants	16 Participants n=90 Participants	37 Participants n=179 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body Mass Index (BMI)	45.4 Kg/m^2 STANDARD_DEVIATION 5.9 • n=89 Participants	44.5 Kg/m^2 STANDARD_DEVIATION 5.5 • n=90 Participants	45 Kg/m^2 STANDARD_DEVIATION 5.7 • n=179 Participants
Diabetes	13 Participants n=89 Participants	13 Participants n=90 Participants	26 Participants n=179 Participants
Hypertension	35 Participants n=89 Participants	29 Participants n=90 Participants	64 Participants n=179 Participants

PRIMARY outcome

Timeframe: within 1 week post-operatively

in hospital total oral and IV morphine equivalents required after laparoscopic bariatric surgery.

Outcome measures

Measure	Liposomal Bupivacaine n=89 Participants Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Exparel 266 MG Per 20 ML Injection: Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).	Control n=90 Participants 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Bupivacaine: 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
Morphine Equivalents	8.3 MEU Standard Deviation 4.0	7.5 MEU Standard Deviation 3.6

SECONDARY outcome

Timeframe: within 48 hours post operatively

Average pain scores by blinded nurse obtained. Analogue pain rating scale ranged from 0 to 10 with 0 being no pain and 10 being the worst possible pain. Assessment of pain and nausea were performed every 4 hours after operation until discharge.

Outcome measures

Measure	Liposomal Bupivacaine n=89 Participants Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Exparel 266 MG Per 20 ML Injection: Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).	Control n=90 Participants 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Bupivacaine: 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
Cumulative Pain Score	3.5 score on a scale Standard Deviation 1.7	3.6 score on a scale Standard Deviation 1.9

Adverse Events

Liposomal Bupivacaine

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Liposomal Bupivacaine n=89 participants at risk Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Exparel 266 MG Per 20 ML Injection: Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).	Control n=90 participants at risk 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites). Bupivacaine: 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
Gastrointestinal disorders Readmission to hospital	3.4% 3/89 • Number of events 3 • 30 days	3.3% 3/90 • Number of events 3 • 30 days
Blood and lymphatic system disorders Reoperations	2.2% 2/89 • Number of events 2 • 30 days	0.00% 0/90 • 30 days

Other adverse events

Adverse event data not reported

Additional Information

Dr. Pearl Ma

University of California-San Francisco Fresno

Phone: 5592614500

Email: pma@fresno.ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place