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NCT Number: NCT03196505

The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery

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.

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Key information

Conditions

Bariatric Surgery Candidate Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fresno Heart and Surgical Hospital

Fresno, California, 93720, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exparel 266 MG Per 20 ML Injection

Drug

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).

Other names: EXPAREL

Bupivacaine

Drug

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).

Other names: Marcaine

Primary outcomes

  1. Morphine Equivalents

    Time frame: within 1 week post-operatively

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

Secondary outcomes

  1. Cumulative Pain Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: Exparel

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 22, 2017
Registry last updated
Nov 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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