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Search / Trial NCT02969187

Bupivacaine Liposomal Injection (Exparel) for Postsurgical Analgesia in Patient Undergoing Laparoscopic Bariatric Surgery

Launched by THE CLEVELAND CLINIC · Nov 17, 2016

Trial Information

Current as of May 14, 2025

Completed

Keywords

ClinConnect Summary

Introduction

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. Some studies have already suggested that infusion with local anesthetics at the wound site can decrease postoperative pain levels. Further, other studies have shown equal amounts of opiate analgesic requirements (administered on patient demand) with placebo and local anesthetic administration. However, varying anesthetic administration techniques used in the different studies may explain w...

Gender

ALL

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

About The Cleveland Clinic

The Cleveland Clinic is a renowned nonprofit academic medical center based in Cleveland, Ohio, recognized for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, the Cleveland Clinic leverages its multidisciplinary expertise and state-of-the-art facilities to conduct groundbreaking studies aimed at improving patient outcomes across a wide range of medical conditions. With a strong emphasis on patient-centered care, the institution fosters collaboration among researchers, clinicians, and patients to explore new treatments and therapies, contributing significantly to the global body of medical knowledge.

Locations

Cleveland, Ohio, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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