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Effects of Intravenous Local Anesthetic on Bowel Function After Colectomy

NCT00600158 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2008-01-24

No results posted yet for this study

Summary

Epidural local anesthetics are the gold standard for shortening duration of bowel dysfunction after bowel surgery. Previous studies suggest that their effect may be in part a result of actions of the local anesthetic outside the epidural space. If local anesthetics could be administered intravenously instead, this might be a safer, easier and less expensive approach. Therefore, this trial will compare the effect on bowel function recovery of intravenous local anesthetics with those administered epidurally.

Conditions

  • Postoperative Ileus

Interventions

DRUG

bupivacaine with hydromorphone

bupivacaine 0.125% with hydromorphone 6 mcg/ml epidurally at 10 ml/h

DRUG

lidocaine

lidocaine 2 mg/min intravenously (or 3 mg/kg in patients \> 70 kg)

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Marcel E Durieux, MD PhD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2006-07-31
Completion
2006-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00600158 on ClinicalTrials.gov