CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Injected bupivacaine post-operatively +3 moredrug
Likely dose
Injected bupivacaine post-operatively 30 mlfrom record
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Search/NCT00508976
NCT00508976Phase 2Completed

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

Pinnacle Health System·interventional·Posted Jul 30, 2007·Updated May 10, 2012

In Brief

A Phase 2 clinical trial evaluating Injected bupivacaine post-operatively, Streamed bupivacaine versus streamed normal saline, and 2 other interventions for Pain, Postoperative and Morbid Obesity. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 30, 2007
Enrollment StartJun 1, 2007
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.9 years ago

Interventions

Injected bupivacaine post-operativelydrug

Patients will receive 30 ml of 0.9% normal saline divided equally and injected prior to port site incision, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation, and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.

Streamed bupivacaine versus streamed normal salinedrug

Patients will receive 30ml of 0.9% normal saline divided equally and injected prior to port site incisions, then 10ml of 0.5% bupivacaine streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.

Aerosolized bupivacaine versus aerosolized salinedrug

Patients will receive 30 ml of 0.9% normal saline divided equally and injected prior to port site incision, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.5% bupivacaine aerosolized into coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.

Injected lidocaine pre-incision vs saline pre-incisiondrug

Patients will receive 30ml of 1% lidocaine divided equally and injected prior to port site incisions, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.