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

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.

Conditions

• Pain, Postoperative
• Morbid Obesity

Interventions

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.

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.

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.

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.

Sponsors & Collaborators

• Pinnacle Health System

  lead OTHER

Principal Investigators

• Troy A Moritz, DO · Pinnacle Health; Community General Osteopathic Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-06-30

Primary Completion

2008-04-30

Completion

2008-04-30

Countries

• United States

Study Locations