Bupivacaine Liposomal Injection (Exparel) for Postsurgical Analgesia in Patient Undergoing Laparoscopic Bariatric Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Exparel; Bupivacain; Saline
Intervention description: 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.; 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.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain
      management, efforts are continuing to find effective methods to relieve pain after abdominal
      surgery. Although opioid is an effective analgesic it has opioid related adverse events
      (ORAEs). Bupivacaine should reduce postoperative pain but it has relatively shorter duration
      of action. Liposome bupivacaine (Exparel) has been approved as a single dose infiltration for
      longer postoperative period analgesic. It provides up to 72 hours analgesia postoperatively;
      results in lesser opioids usage and reduce the ORAEs. Transversus abdominis plane (TAP) block
      is a relatively new regional anesthetic technique. TAP blocks have been performed to reduce
      opioid use and control pain in several laparoscopic surgical procedures, including colorectal
      resections, cholecystectomy and bariatric surgery. The aim of this study is to study the
      opiate usage, pain and nausea post laparoscopic gastric bypass or sleeve gastrectomy using
      Exparel versus Bupivacaine as TAP block and port sites infiltration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fulfills NIH criteria for bariatric surgery

          -  Planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic
             sleeve gastrectomy (LSG) as primary bariatric procedure

        Exclusion Criteria:

          -  BMI <35 and > 60 kg/m2

          -  Inability to walk (bed-bound or wheelchair dependence)

          -  Previous major abdominal surgery (possible adhesions and longer operation) defined as:

               -  open abdominal surgeries except simple appendectomy and common OB/GYN procedures
                  in the pelvis (hysterectomy, C-section, and oophorectomy, tubal ligation)

               -  laparoscopic bowel or solid organ resection except laparoscopic cholecystectomy

               -  ventral hernia repair with mesh

          -  Preoperative chronic opiate use for chronic pain defined as opiate usage at least 60
             mg/day of morphine equivalent for ≥ 3 months (as defined by International Association
             for the Study of Pain22) in the one year period prior to the bariatric surgery

          -  The American Society of Anesthesiologists (ASA) score > 3

          -  History of hypersensitivity or adverse reaction to bupivacaine or narcotics

          -  Inability to speak English

          -  Concurrent surgical procedure including:

               -  ventral hernia repair

               -  Cholecystectomy

               -  hiatal hernia repair with posterior cruroplasty

               -  extensive lysis of adhesions

               -  other procedures that mandate addition of "trocar(s)" or "feeding tube"

          -  Addition of trocar(s) or conversion of surgery to hand-assisted or open