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Sponsored by: |
University of Virginia |
Information provided by: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT00600158 |
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 |
MedlinePlus related topics: | Anesthesia |
Drug Information available for: | Hydromorphone Hydromorphone hydrochloride Lidocaine Bupivacaine Bupivacaine hydrochloride |
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 |
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
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Drug: lidocaine
lidocaine 2 mg/min intravenously (or 3 mg/kg in patients > 70 kg)
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1: Active Comparator
epidural local anesthetic
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Drug: bupivacaine with hydromorphone
bupivacaine 0.125% with hydromorphone 6 mcg/ml epidurally at 10 ml/h
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Show Detailed Description |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Virginia | |||||
University of Virginia | |||||
Charlottesville, Virginia, United States, 22908 |
University of Virginia |
Principal Investigator: | Marcel E Durieux, MD PhD | University of Virginia |
Responsible Party: | University of Virginia ( Marcel E. Durieux, MD PhD, Professor of Anesthesiology ) |
Study ID Numbers: | MED001 |
First Received: | January 11, 2008 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00600158 |
Health Authority: | United States: Institutional Review Board |
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