Intravenous Lidocaine and Acute Rehabilitation

Pain, Postoperative Clinical Trial

Official title:

Intravenous Lidocaine Infusion Improves Outcome After Laparoscopic Colectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330941
• Other study ID #: Joris, Lidocaine Outcomes
• Status: Completed
• Phase: Phase 4
• Start date: January 2003
• Est. completion date: December 2004

Study information

• Verified date: April 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Consumption, Postoperative
• Pain, Postoperative
• Postoperative Fatigue

Intervention

Drug:
• lidocaine

Locations

Country	Name	City	State
Belgium	CHU de Liège, University of Liège	Liege

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sevoflurane consumption
Primary	Pain scores
Primary	abdominal comfort
Primary	fatigue scores
Secondary	bowel function
Secondary	hospital stay
Secondary	endocrine and metabolic responses