The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery
Condition: Bariatric Surgery Candidate; Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Exparel 266 MG Per 20 ML Injection; Bupivacaine
Intervention description: 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).; 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).
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 231.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Anesthetics, Local; Liposomal Bupivacaine; Bupivacaine; Postoperative Complications; Roux-en-Y Gastric Bypass; Sleeve Gastrectomy; Laparoscopic Bariatric Surgery

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.