Clinical Proposal for the Comparison of Intraperitoneal Anesthetic to Injected Local Anesthetic

Condition(s) targeted: Pain, Postoperative; Morbid Obesity

Intervention: Injected bupivacaine post-operatively (Drug); Streamed bupivacaine versus streamed normal saline (Drug); Aerosolized bupivacaine versus aerosolized saline (Drug); Injected lidocaine pre-incision vs saline pre-incision (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pinnacle Health System

Official(s) and/or principal investigator(s):
Troy A Moritz, DO, Principal Investigator, Affiliation: Pinnacle Health; Community General Osteopathic Hospital

The purpose of this study is to determine if pre-incisional lidocaine injection, instilled liquid bupivacaine, intra-abdominal aerosolized bupivacaine, or post-operative bupivacaine injection is superior in post-operative pain control in laparoscopic bariatric surgical patients.

Official title: Evaluation of Aerosolized Bupivacaine Versus Pre-incision Lidocaine Versus Instilled Liquid Bupivacaine Versus Post-operative Bupivacaine Injection for Optimization of Post-operative Pain Control in Laparoscopic Bariatric Surgical Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Measure of reduction in post-operative pain and narcotics usage.

Detailed description: The research objective is to compare our standard post-operative port site injection of 0. 5% bupivacaine against pre-incisional port site injection of 1% lidocaine against the instillation of streamed bupivacaine 0. 5% against the instillation of aerosolized 0. 5% bupivacaine as it relates to post-operative analgesia usage and pain scale scores. The null hypothesis will be that there is no difference between the four arms of the study in regards to pain score and analgesia usage.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Male and female patients between 18 and 65 years of age. 2. Patients undergoing elective bariatric surgery. Exclusion Criteria: 1. Patients allergic to bupivacaine or any other local anesthetics (amides & esters). 2. Patients who have used opiates or opiods within 15 days prior to surgery. 3. Patients converted to open gastric bypass.

Pinnacle Health; Community General Osteopathic Hospital, Harrisburg, Pennsylvania 17109, United States

Related publications:

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Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. Epub 2006 Dec 16.

Barczyński M, Konturek A, Herman RM. Superiority of preemptive analgesia with intraperitoneal instillation of bupivacaine before rather than after the creation of pneumoperitoneum for laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled study. Surg Endosc. 2006 Jul;20(7):1088-93. Epub 2006 May 13.

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Starting date: June 2007
Last updated: May 9, 2012