Intravenous Lidocaine and Acute Rehabilitation

NCT ID: NCT00330941

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2004-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

lidocaine

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Liege

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Principal Investigators

Jean Joris, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

CHU de Liège, University of Liège

Liège, , Belgium

Countries

Belgium

Other Identifiers

Joris, Lidocaine Outcomes

Identifier Type: -

Identifier Source: org_study_id