Trial | NCT00508976  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    lidocaine levobupivacaine ...

  • Study Participants

    100
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.
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 Started
Jun 30
2007
Primary Completion
Apr 30
2008
Study Completion
Apr 30
2008
Last Update
May 10
2012
Estimate

Drug Injected bupivacaine post-operatively

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.

  • Other names: bupivacaine

Drug Streamed bupivacaine versus streamed normal saline

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.

  • Other names: bupivacaine, marcaine, normal saline

Drug Aerosolized bupivacaine versus aerosolized saline

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.

  • Other names: bupivacaine, marcaine, normal saline, aerosolized

Drug Injected lidocaine pre-incision vs saline pre-incision

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.

  • Other names: lidocaine, normal saline, pre-emptive

3 Experimental

2 Experimental

4 Experimental

1 Active Comparator

Criteria 

Inclusion Criteria:

Male and female patients between 18 and 65 years of age.
Patients undergoing elective bariatric surgery.

Exclusion Criteria:

Patients allergic to bupivacaine or any other local anesthetics (amides & esters).
Patients who have used opiates or opiods within 15 days prior to surgery.
Patients converted to open gastric bypass.
No Results Posted