Clinical Proposal for the Comparison of Intraperitoneal Anesthetic to Injected Local Anesthetic
Information source: Pinnacle Health System
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative; Pain Measurement; Postoperative Care
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
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
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: Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study
Primary outcome: Measure of reduction in post-operative pain and narcotics usage.
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.
1. Male and female patients between 18 and 65 years of age.
2. Patients undergoing elective bariatric surgery.
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.
Locations and Contacts
Pinnacle Health; Community General Osteopathic Hospital, Harrisburg, Pennsylvania 17109, United States
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Starting date: June 2007
Ending date: April 2008
Last updated: May 21, 2008