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

Sponsor:	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:	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:

MedlinePlus related topics: Bowel Movement

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
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

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):

Swenson BR, Gottschalk A, Wells LT, Rowlingson JC, Thompson PW, Barclay M, Sawyer RG, Friel CM, Foley E, Durieux ME. Intravenous lidocaine is as effective as epidural bupivacaine in reducing ileus duration, hospital stay, and pain after open colon resection: a randomized clinical trial. Reg Anesth Pain Med. 2010 Jul-Aug;35(4):370-6.

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
Analgesics
Narcotics
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012