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

Phase 2

Completed

• Conditions: Pain, Postoperative; Morbid Obesity
• Interventions: Drug: Injected lidocaine pre-incision vs saline pre-incision; Drug: Aerosolized bupivacaine versus aerosolized saline; Drug: Injected bupivacaine post-operatively; Drug: Streamed bupivacaine versus streamed normal saline

• Registration Number: NCT00508976
• Lead Sponsor: Pinnacle Health System

Brief Summary

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.

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-26
• Study First Submitted QC: 2007-07-26
• Study First Posted: 2007-07-30
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-09
• Last Update Posted: 2012-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2	Injected lidocaine pre-incision vs saline pre-incision	-
4	Aerosolized bupivacaine versus aerosolized saline	-
1	Injected bupivacaine post-operatively	-
3	Streamed bupivacaine versus streamed normal saline	-

Primary Outcome Measures

Name	Time	Method
Measure of reduction in post-operative pain and narcotics usage.	First 3 days post-operatively.

Trial Locations

Locations (1)

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