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Intravenous Lidocaine and Acute Rehabilitation

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ClinicalTrials.gov Identifier: NCT00330941
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : June 29, 2016
Sponsor:
Collaborator:
University of Liege
Information provided by:
The Cleveland Clinic

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Opioid Consumption, Postoperative Postoperative Fatigue Drug: lidocaine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Intravenous Lidocaine Infusion Improves Outcome After Laparoscopic Colectomy
Study Start Date : January 2003
Study Completion Date : December 2004

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Sevoflurane consumption
  2. Pain scores
  3. abdominal comfort
  4. fatigue scores

Secondary Outcome Measures :
  1. bowel function
  2. hospital stay
  3. endocrine and metabolic responses

Eligibility Criteria
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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330941


Locations
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Belgium
CHU de Liège, University of Liège
Liege, Belgium, B-4000
Sponsors and Collaborators
The Cleveland Clinic
University of Liege
Investigators
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Study Director: Jean Joris, MD, PhD Department of Anesthesia and Intensive Care Medicine, CHU de Liège, University of Liège, Belgium
More Information
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ClinicalTrials.gov Identifier: NCT00330941    
Other Study ID Numbers: Joris, Lidocaine Outcomes
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Pain, Postoperative
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action