Effects of Intravenous Local Anesthetic on Bowel Function After Colectomy

This study has been completed.
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
First received: January 11, 2008
Last updated: January 23, 2008
Last verified: January 2008
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.

Condition Intervention Phase
Postoperative Ileus
Drug: bupivacaine with hydromorphone
Drug: lidocaine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Intravenous Local Anesthetic on Bowel Function After Colectomy

Resource links provided by NLM:

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • time from end of surgery to first sign of bowel function (stool or flatus) [ Time Frame: follow-up after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative pain and opiate consumption [ Time Frame: post-surgery follow-up ] [ Designated as safety issue: No ]
  • postoperative nausea and antiemetic use [ Time Frame: post-surgery follow-up ] [ Designated as safety issue: Yes ]
  • duration of hospital stay [ Time Frame: post-surgery follow-up ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: April 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
lidocaine intravenously
Drug: lidocaine
lidocaine 2 mg/min intravenously (or 3 mg/kg in patients > 70 kg)
Active Comparator: 1
epidural local anesthetic
Drug: bupivacaine with hydromorphone
bupivacaine 0.125% with hydromorphone 6 mcg/ml epidurally at 10 ml/h

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Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed consent
  • Scheduled for colon tumor resection.
  • American Society of Anesthesiologists (ASA) physical classification classes I, II, and III.

Exclusion Criteria:

  • Age <18 or >75 years
  • Allergy to local anesthetics
  • Severe cardiovascular disease (myocardial infarction within 6 months, profoundly decreased left ventricular function (ejection fraction <40%), or high-grade arrhythmias) or liver disease (known AST or ALT or bilirubin >2.5 times the upper limit of normal)
  • Systemic corticosteroid use
  • Chronic use of opiates
  • Unwillingness or contraindication to epidural analgesia.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00600158

United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Principal Investigator: Marcel E Durieux, MD PhD University of Virginia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marcel E. Durieux, MD PhD, Professor of Anesthesiology, University of Virginia
ClinicalTrials.gov Identifier: NCT00600158     History of Changes
Other Study ID Numbers: MED001 
Study First Received: January 11, 2008
Last Updated: January 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:

Additional relevant MeSH terms:
Anesthetics, Local
Analgesics, Opioid
Anti-Arrhythmia Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on May 26, 2016