Trial Outcomes & Findings for Bupivacaine Liposomal Injection (Exparel) for Postsurgical Analgesia in Patient Undergoing Laparoscopic Bariatric Surgery (NCT NCT02969187)

Results Overview

The total amount of opioids used will be recorded from the nurse chart.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

126 participants

Primary outcome timeframe

At 48 hours post operative

Results posted on

2020-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to study arm and control arm. 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Study arm receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline (total: 200ml) * Transverse Abdominis Plane (TAP) block: 140 ml * Port site infiltration:60ml	Control Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to study arm and control arm. 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Control arm receive 60ml of 0.5% Bupivacaine + 140 ml of Saline (total: 200ml) * Transverse Abdominis Plane (TAP) block: 140 ml * Port site infiltration:60ml
Overall Study STARTED	63	63
Overall Study COMPLETED	51	50
Overall Study NOT COMPLETED	12	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to study arm and control arm. 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Study arm receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline (total: 200ml) * Transverse Abdominis Plane (TAP) block: 140 ml * Port site infiltration:60ml	Control Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to study arm and control arm. 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Control arm receive 60ml of 0.5% Bupivacaine + 140 ml of Saline (total: 200ml) * Transverse Abdominis Plane (TAP) block: 140 ml * Port site infiltration:60ml
Overall Study Physician Decision	12	13

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=51 Participants Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline Exparel: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Exparel will be injected at port sites. Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites. Saline	Control n=50 Participants Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 60ml of 0.5% Bupivacaine + 140 ml of Saline. Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites. Saline	Total n=101 Participants Total of all reporting groups
Age, Continuous	41.1 years n=51 Participants	41.2 years n=50 Participants	41.1 years n=101 Participants
Sex: Female, Male Female	40 Participants n=51 Participants	38 Participants n=50 Participants	78 Participants n=101 Participants
Sex: Female, Male Male	11 Participants n=51 Participants	12 Participants n=50 Participants	23 Participants n=101 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	44 kg/m2 n=51 Participants	44 kg/m2 n=50 Participants	44 kg/m2 n=101 Participants

PRIMARY outcome

Timeframe: At 48 hours post operative

Population: A total of 126 patients were randomized in this study. Out of that, 25 patients were excluded due either inadequate data, not prescribed post-operative ketorolac or intraoperative additional procedures performed. A total of 101 patients were included;

The total amount of opioids used will be recorded from the nurse chart.

Outcome measures

Outcome measures
Measure	Experimental n=51 Participants Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline Exparel: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Exparel will be injected at port sites. Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites. Saline	Control n=50 Participants Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 60ml of 0.5% Bupivacaine + 140 ml of Saline. Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites. Saline
Total Amount of Opioids at 48 Hours	29.5 mg Standard Deviation 17.1	27.1 mg Standard Deviation 14.3

SECONDARY outcome

Timeframe: Pain assessed when the patient is admitted to the recovery room after surgery, every 8 hrs thereafter for up to 48 hours post operatively

Description: We used a time weight average (TWA) pain score in frequent measurements of pain score. Cumulative pain score through 48 hours after surgery is the summation of all the time weight average pain scores with a range from 0 to 440. The high score represents the worse outcomes. 0 means no pain during the whole time and 440 means severe pain during the whole time.

Outcome measures

Outcome measures
Measure	Experimental n=51 Participants Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline Exparel: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Exparel will be injected at port sites. Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites. Saline	Control n=50 Participants Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 60ml of 0.5% Bupivacaine + 140 ml of Saline. Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites. Saline
Cumulative Pain Score Through 48 Hours After Surgery	177.0 score on a scale Standard Deviation 62.9	167.8 score on a scale Standard Deviation 62.3

SECONDARY outcome

Timeframe: Nausea assessed when the patient is admitted to the recovery room after surgery, every 8 hrs thereafter for up to 72 hours post operatively

Description: We used a time weight average (TWA) method in adjusting the nausea score. Cumulative nausea score through 72 hours after surgery is the summation of all the time weight average nausea scores with a range from 68-272. The high score represents the worse outcomes. 68 means no nausea during the whole time and 272 means severe nausea during the whole time.

Outcome measures

Outcome measures
Measure	Experimental n=51 Participants Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline Exparel: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Exparel will be injected at port sites. Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites. Saline	Control n=50 Participants Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 60ml of 0.5% Bupivacaine + 140 ml of Saline. Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites. Saline
Cumulative Nausea Score	79 score on a scale Standard Deviation 12	98 score on a scale Standard Deviation 35

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental n=51 participants at risk Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline Exparel: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Exparel will be injected at port sites. Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites. Saline	Control n=50 participants at risk Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 60ml of 0.5% Bupivacaine + 140 ml of Saline. Bupivacain: 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites. Saline
Skin and subcutaneous tissue disorders Minor adverse event	3.9% 2/51 • Number of events 2 • Two patients in the study arm developed urticarial rashes over the abdominal wall at the site of injection. Their rashes were noticed on day 7 after the procedure during follow up visit in the clinic by the attending physician. Two patients in the study arm developed urticarial rash over the abdominal wall at the site on injection noticed at 1 week post procedure during follow up visit. The rash noticed at 1 week post procedure during follow up visit. The rash was itchy but limited only to the abdominal area at the injection site. No other adverse events noted. At subsequent follow up, the rash has resolved.	0.00% 0/50 • Two patients in the study arm developed urticarial rashes over the abdominal wall at the site of injection. Their rashes were noticed on day 7 after the procedure during follow up visit in the clinic by the attending physician. Two patients in the study arm developed urticarial rash over the abdominal wall at the site on injection noticed at 1 week post procedure during follow up visit. The rash noticed at 1 week post procedure during follow up visit. The rash was itchy but limited only to the abdominal area at the injection site. No other adverse events noted. At subsequent follow up, the rash has resolved.

Additional Information

Dr. Philip R. Schauer

Cleveland Clinic

Phone: 216-444-4794

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place