Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine

Ketamine

Brief 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.

Intervention / Treatment

  • Lidocaine, (DRUG)
    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 (DRUG)
    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 (DRUG)
    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 (DRUG)
    The control group (C) received an equal volume of saline 0.9 % during 48 h.

Condition or Disease

  • Postoperative Pain

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 20 Years to 75 Years
    Enrollment: 52 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Dec 01, 2005
    Primary Completion: Jul 01, 2007 ACTUAL
    Completion Date: Jul 01, 2007 ACTUAL
    Study First Posted: Sep 23, 2011 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 21, 2011

    Sponsors / Collaborators

    Lead Sponsor: University of Lausanne Hospitals
    Responsible Party: N/A

    Location

    Vaud, Switzerland
    Lausanne, Vaud, Switzerland

    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.

    Participant Groups

    • Intravenous lidocaine administered preoperatively (anesthesia induction) and postoperatively during 48 hours

    • Intravenous ketamine administered preoperatively (anesthesia induction) and postoperatively during 48 hours

    • Intravenous association of ketamine and lidocaine administered preoperatively (at anesthesia induction) and postoperatively during 48 hours.

    • Control group

    Eligibility Criteria

    Sex: All
    Minimum Age: 20
    Maximum Age: 75
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Cumulative morphine consumption over 48 hours postoperatively

    Secondary Outcomes

    • Pain scores at rest and movement

    • Mechanical hyperalgesia using pressure algometry

    • Occurrence of side effects: sedation, nausea, vomiting, itching, nightmares

    More Details

    NCT Number: NCT01439399
    Other IDs: KL-48h
    Study URL: https://clinicaltrials.gov/study/NCT01439399
    Last updated: Sep 29, 2023