Effects of Intravenous Local Anesthetic on Bowel Function After Colectomy

This study has been completed.
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00600158
First received: January 11, 2008
Last updated: January 23, 2008
Last verified: January 2008
  Purpose

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

  Show Detailed Description

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600158

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

No publications provided by University of Virginia

Additional 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:
colectomy

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anesthetics, Local
Bupivacaine
Lidocaine
Anesthetics
Hydromorphone
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014