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OpenTrials
Completed

NCT Number: NCT00330941

Intravenous Lidocaine and Acute Rehabilitation

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Liège, University of Liège

Liège, B-4000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

Primary outcomes

  1. Sevoflurane consumption

  2. Pain scores

  3. abdominal comfort

  4. fatigue scores

Secondary outcomes

  1. bowel function

  2. hospital stay

  3. endocrine and metabolic responses

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • University of Liege

Registry information

Official study title

Intravenous Lidocaine Infusion Improves Outcome After Laparoscopic Colectomy

Important dates

Study start
2003
Study completion
2004
First posted
May 29, 2006
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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