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

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

Conditions
Pain, PostoperativeMorbid 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.

Trial Locations (1)

17109

Pinnacle Health; Community General Osteopathic Hospital, Harrisburg

All Listed Sponsors
lead

Pinnacle Health System

OTHER

NCT00508976 - Clinical Proposal for the Comparison of Intraperitoneal Anesthetic to Injected Local Anesthetic | Biotech Hunter | Biotech Hunter