Intravenous Lidocaine and Acute Rehabilitation

NCT00330941 | Completed Phase 4

• 1 other identifier: Joris, Lidocaine Outcomes
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Opioid Consumption, Postoperative; Postoperative Fatigue

Outcome Measures

Primary Outcomes (4)

• Sevoflurane consumption

• Pain scores

• abdominal comfort

• fatigue scores

Secondary Outcomes (3)

• bowel function

• hospital stay

• endocrine and metabolic responses

Interventions

lidocaine DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-III
• non-malignant disease

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• University of Liege: collaborator

Study Sites (1)

CHU de Liège, University of Liège

Liège, B-4000, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jean Joris, MD, PhD

  Department of Anesthesia and Intensive Care Medicine, CHU de Liège, University of Liège, Belgium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 25, 2006
• First Posted: May 29, 2006
• Study Start: January 1, 2003
• Study Completion: December 1, 2004
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

BE (1)