Home
Search
Study Topics
Glossary
|
|
|
|
|
|
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 |
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
|
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
|
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 |
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 |
Study First Received: | January 11, 2008 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00600158 |
Health Authority: | United States: Institutional Review Board |
colectomy |
Hydromorphone Ileus Lidocaine Bupivacaine |
Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Cardiovascular Agents Anesthetics, Local Pharmacologic Actions |
Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Anti-Arrhythmia Agents Central Nervous System Agents Analgesics, Opioid |