Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine

Postoperative Pain Clinical Trial

Official title:

Analgesic Efficacy of Intravenous Perfusion of Lidocaine, Ketamine or a Combination After Laparotomy in a Placebo-controlled, Randomized, Double-blind Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439399
• Other study ID #: KL-48h
• Secondary ID: 179/05
• Status: Completed
• Phase: N/A
• First received: September 20, 2011
• Last updated: September 21, 2011
• Start date: December 2005
• Est. completion date: July 2007

Study information

• Verified date: September 2011
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine and ketamine in the perioperative period of abdominal surgery.

Description:

Optimal postoperative pain management facilitates rehabilitation immediately after abdominal surgery. Multiple studies have demonstrated that successful postoperative analgesia also reduces perioperative complications and improves patient comfort, thereby providing many benefits for the patient. In acute postoperative pain management intravenous lidocaine and/or ketamine have been advocated because of their morphine-sparing effect.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• abdominal surgery by laparotomy

Exclusion Criteria:

• laparoscopy

• history of chronic pain

• opioid self-administration

• psychiatric disorders

• difficulties with communication

• renal or hepatic dysfunction

• ASA physical status > 3

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Lidocaine,
Lidocaine group received an IV bolus of 1.5 mg.kg-1 followed by a continuous infusion of 2 mg.kg-1.h-1 intraoperative and 1.33 mg.kg-1.h-1 for 48 h postoperative.
• Ketamine
Ketamine group received a bolus of 0.5 mg.kg-1, then 0.25 mg.kg-1.h-1 followed by 0.1 mg.kg-1.h-1 for the first 24 h, then 0.05 mg.kg-1.h-1 for the next 24 h.
• association ketamine-lidocaine
Ketamine-lidocaine group received a bolus of 1.5 mg.kg-1 of lidocaine and 0.5 mg.kg-1 of ketamine, a continuous infusion of 1.3 mg.kg-1.h-1 of lidocaine and 0.17 mg.kg-1.h-1 of ketamine was delivered followed by 0.9 mg.kg-1 of lidocaine with 0.08 mg.kg-1.h-1 of ketamine during 48 h, the dose of ketamine being reduced to 0.04 mg.kg-1.h-1 after the first 24 hours.
• Placebo
The control group (C) received an equal volume of saline 0.9 % during 48 h.

Locations

Country	Name	City	State
Switzerland	University Hospital Center and University	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative morphine consumption	Cumulative morphine consumption over 48 hours postoperatively	48 hours	Yes
Secondary	Pain scores	Pain scores at rest and movement	48 hours	Yes
Secondary	Mechanical hyperalgesia	Mechanical hyperalgesia using pressure algometry	48 hours	Yes
Secondary	Occurrence of side effects	Occurrence of side effects: sedation, nausea, vomiting, itching, nightmares	48 hours	Yes