- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00330941
Intravenous Lidocaine and Acute Rehabilitation
Intravenous Lidocaine Infusion Improves Outcome After Laparoscopic Colectomy
Background: Intravenous infusion of lidocaine may decrease postoperative pain and speed return of bowel function. The investigators therefore tested the hypothesis that including perioperative lidocaine infusion improves recovery from laparoscopic colectomy and shortens the duration of hospitalization.
Methods: Forty patients scheduled for laparoscopic colectomy were randomly allocated to receive intravenous lidocaine (bolus injection of 1.5 mg.kg-1 lidocaine at induction of anesthesia, then a continuous infusion of 2 mg.kg-1.h-1 intraoperatively and 1.33 mg.kg-1.h-1 for 24 h postoperatively) or an equal volume of saline. All patients received similar intensive postoperative rehabilitation. Postoperative pain scores, opioid consumption, and fatigue scores were measured. Times to first flatus, defecation, and hospital discharge were recorded. Postoperative endocrine (cortisol and catecholamines) and metabolic (leucocytes, C-reactive protein, and glucose) responses were measured for 48 h. Data (median [25%-75% interquartile range] Saline vs Lidocaine groups) were analyzed using Mann-Whitney tests. P<0.05 was considered statistically significant.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Liege, Belgium, B-4000
- CHU de Liège, University of Liège
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ASA I-III
- non-malignant disease
Exclusion Criteria:
- greater than 70 years
- history of gastro-duodenal peptic ulcer or renal failure (contraindications to the use of nonsteroidal anti-inflammatory drug)
- hepatic insufficiency
- psychiatric disorder
- steroid treatment
- chronic treatment with opioid
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Sevoflurane consumption
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Pain scores
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abdominal comfort
|
fatigue scores
|
Secondary Outcome Measures
Outcome Measure |
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bowel function
|
hospital stay
|
endocrine and metabolic responses
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Jean Joris, MD, PhD, Department of Anesthesia and Intensive Care Medicine, CHU de Liège, University of Liège, Belgium
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- Joris, Lidocaine Outcomes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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