Effects of Intravenous Local Anesthetic on Bowel Function After Colectomy
1 other identifier
interventional
45
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2005
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 11, 2008
CompletedFirst Posted
Study publicly available on registry
January 24, 2008
CompletedJanuary 24, 2008
January 1, 2008
1.2 years
January 11, 2008
January 23, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time from end of surgery to first sign of bowel function (stool or flatus)
follow-up after surgery
Secondary Outcomes (3)
Postoperative pain and opiate consumption
post-surgery follow-up
postoperative nausea and antiemetic use
post-surgery follow-up
duration of hospital stay
post-surgery follow-up
Study Arms (2)
2
EXPERIMENTALlidocaine intravenously
1
ACTIVE COMPARATORepidural local anesthetic
Interventions
bupivacaine 0.125% with hydromorphone 6 mcg/ml epidurally at 10 ml/h
Eligibility Criteria
You may qualify if:
- Informed consent
- Scheduled for colon tumor resection.
- American Society of Anesthesiologists (ASA) physical classification classes I, II, and III.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22908, United States
Related Publications (1)
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. doi: 10.1097/AAP.0b013e3181e8d5da.
PMID: 20588151DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcel E Durieux, MD PhD
University of Virginia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 11, 2008
First Posted
January 24, 2008
Study Start
April 1, 2005
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
January 24, 2008
Record last verified: 2008-01