Clinical trial NCT03196505: The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery
Official title: The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bariatric Surgery Candidate
Pain, Postoperative
Keywords: Anesthetics, Local
Liposomal Bupivacaine
Bupivacaine
Postoperative Complications
Roux-en-Y Gastric Bypass
Sleeve Gastrectomy
Laparoscopic Bariatric Surgery
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is prospective, randomized trial in which the efficacy of liposomal bupivacaine (Exparel®) is compared to standard bupivacaine local surgical site injection in reducing total IV and oral morphine equivalents required after laparoscopic bariatric surgery. Liposomal bupivacaine is a 72-hour bupivacaine that is slowly released from tissue over the course of three days. Having a long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3.5-hour half-life. In some studies, the use of liposomal bupivacaine has been shown to decrease pain and narcotic use after surgery. This has not yet been studied in bariatric patients and the use of liposomal bupivacaine can potentially improve patient post-operative pain control, decrease narcotic use, decrease hospital length of stay and readmission rates and improve patient satisfaction after bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing elective laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass surgeries.
* Fulfills NIH criteria for bariatric surgery

Exclusion Criteria:

* Patients deemed not a candidate for laparoscopic bariatric surgery
* Patients with previous bariatric or gastric surgeries.
* BMI \<35 and \> 60 kg/m2
* Preoperative inability to ambulate and confined to wheelchair.
* American Society of Anesthesiologist (ASA) score \>3
* Concurrent ventral hernia repair or intraoperative extensive lysis of adhesions
* Not able to understand informed consent, or unwilling to sign consent.
* Not able to understand and read English
* Currently pregnant or lactating.
* Age \<18 or \>65
* Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
* Patients requiring opiate use within 30 days prior to time of surgery.
* Patients with reported use of narcotics greater than 2 weeks in preceding year before surgery.
* Patients with history of substance abuse, alcohol addiction
* Patients with diagnosis of chronic pain, history of fibromyalgia, chronic regional pain syndrome (dystrophic pain syndrome).
* Bupivacaine use within 96 hours before operation
* Prisoners
* Bariatric surgery operation \>3 hours.
* More than 5 laparoscopic incision sites used during surgery, conversion to open operation, placement of a feeding tube or drain.
* Patients with renal failure or hepatic failure.

Primary outcomes:
measure: Morphine Equivalents
timeFrame: within 1 week post-operatively
Secondary outcomes:
measure: Cumulative Pain Score
timeFrame: within 48 hours post operatively
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Fresno Heart and Surgical Hospital
state: California
Study officials:
affiliation: University of San Francisco - Fresno
name: Pearl Ma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma P, Lloyd A, McGrath M, Shuchleib Cung A, Akusoba I, Jackson A, Swartz D, Boone K, Higa K. Efficacy of liposomal bupivacaine versus bupivacaine in port site injections on postoperative pain within enhanced recovery after bariatric surgery program: a randomized clinical trial. Surg Obes Relat Dis. 2019 Sep;15(9):1554-1562. doi: 10.1016/j.soard.2019.06.004. Epub 2019 Jun 17.