Intravenous Lidocaine and Acute Rehabilitation
Primary Purpose
Pain, Postoperative, Opioid Consumption, Postoperative, Postoperative Fatigue
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
lidocaine
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative
Eligibility 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
Sites / Locations
- CHU de Liège, University of Liège
Outcomes
Primary Outcome Measures
Sevoflurane consumption
Pain scores
abdominal comfort
fatigue scores
Secondary Outcome Measures
bowel function
hospital stay
endocrine and metabolic responses
Full Information
NCT ID
NCT00330941
First Posted
May 25, 2006
Last Updated
April 12, 2023
Sponsor
The Cleveland Clinic
Collaborators
University of Liege
1. Study Identification
Unique Protocol Identification Number
NCT00330941
Brief Title
Intravenous Lidocaine and Acute Rehabilitation
Official Title
Intravenous Lidocaine Infusion Improves Outcome After Laparoscopic Colectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The Cleveland Clinic
Collaborators
University of Liege
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Opioid Consumption, Postoperative, Postoperative Fatigue
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
45 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
lidocaine
Primary Outcome Measure Information:
Title
Sevoflurane consumption
Title
Pain scores
Title
abdominal comfort
Title
fatigue scores
Secondary Outcome Measure Information:
Title
bowel function
Title
hospital stay
Title
endocrine and metabolic responses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Joris, MD, PhD
Organizational Affiliation
Department of Anesthesia and Intensive Care Medicine, CHU de Liège, University of Liège, Belgium
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Liège, University of Liège
City
Liege
ZIP/Postal Code
B-4000
Country
Belgium
12. IPD Sharing Statement
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Intravenous Lidocaine and Acute Rehabilitation
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