Effects of Intravenous Local Anesthetic on Bowel Function After Colectomy - Full Text View

Sponsored by:	University of Virginia
Information provided by:	University of Virginia
ClinicalTrials.gov Identifier:	NCT00600158

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Intravenous Local Anesthetic on Bowel Function After Colectomy

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Surgery

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Hydromorphone hydrochloride Lidocaine Hydromorphone

U.S. FDA Resources

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
2: Experimental lidocaine intravenously	Drug: lidocaine lidocaine 2 mg/min intravenously (or 3 mg/kg in patients > 70 kg)
1: Active Comparator 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

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

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

Keywords provided by University of Virginia:

colectomy

Study placed in the following topic categories:

Hydromorphone
Lidocaine
Anesthetics
Central Nervous System Depressants
Narcotics
Cardiovascular Agents
Anesthetics, Local

Ileus
Bupivacaine
Peripheral Nervous System Agents
Analgesics
Anti-Arrhythmia Agents
Analgesics, Opioid

Additional relevant MeSH terms:

Hydromorphone
Physiological Effects of Drugs
Lidocaine
Anesthetics
Central Nervous System Depressants
Narcotics
Cardiovascular Agents
Anesthetics, Local
Pharmacologic Actions

Sensory System Agents
Therapeutic Uses
Bupivacaine
Anti-Arrhythmia Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 06, 2009