Lidocaine and Ketamine in Abdominal Surgery

Ketamine

Brief Summary

This study is being done to determine if combined infusions of lidocaine and ketamine is better than a lidocaine or ketamine infusion alone, or to placebo in improving recovery after abdominal hysterectomy. Participants will be randomized into one of four groups. Evaluations will be done through walking tests, pain and fatigue questionnaires and blood tests.

Intervention / Treatment

  • Lidocaine (DRUG)
    Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.
  • Placebo (DRUG)
    Placebo boluses and infusions will be substituted
  • Ketamine (DRUG)
    Ketamine (0.25 mg/kg) will be given followed by an infusion of ketamine (0.25 mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
  • Ketamine + Lidocaine (DRUG)
    both Ketamine and Lidocaine will be given

Condition or Disease

  • Abdominal Hysterectomy (& Wertheim)

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years to 75 Years
    Enrollment: 64 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

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

    Clinical Trial Dates

    Start date: Jul 01, 2008
    Primary Completion: Oct 01, 2010 ACTUAL
    Completion Date: Jul 01, 2012 ACTUAL
    Study First Posted: Jul 23, 2008 ESTIMATED
    Results First Posted: Jul 26, 2017 ACTUAL
    Last Updated: Apr 17, 2017

    Sponsors / Collaborators

    Lead Sponsor: The Cleveland Clinic
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Mayfield Heights, Ohio, USA

    Subjects undergoing abdominal hysterectomy surgery are randomized into one of four groups: Intravenous Lidocaine, Intravenous Ketamine, Intravenous Lidocaine and Ketamine or Placebo. Subjects will perform a six-minute walk test prior to surgery and on the second day postoperatively. After surgery and on days 1 and 2 after surgery, subjects will rate their pain. On day 1 postoperatively, subjects will rate their fatigue. On postoperative days 1 and 2 incisional pain will be analysed using von Frey filaments. Two hours after surgery, 10 ml of venous blood will be sampled for cytokine analysis. Telephone follow up will take place 6 and 12 months postoperatively to access pain and quality of life.

    Participant Groups

    • Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery

    • A lidocaine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.

    • Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery

    • both ketamine and Lidocaine are administered intravenously throughout surgery and during the 24 hours after surgery.

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 75
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Age greater than 18 years old and less than 75 years years old
    * Horizontal abdominal incision

    Exclusion Criteria:

    * Emergency or urgent procedure
    * Preexisting chronic pain (at any site) requiring treatment
    * Contraindication to any study medication (ketamine or lidocaine)
    * History of significant Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
    * Significant hepatic (ALT or AST \> 2 times normal) or renal (serum creatinine \> 2 mg/dl) impairment
    * Seizure disorder requiring medication within past 2 years
    * Planned spinal or epidural anesthesia or analgesia

    Primary Outcomes

    • The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery.

    Secondary Outcomes

    • Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain.

    • Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 intraoperative through postoperative day 2
    • Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day 2 hours after surgery, on postoperative day 1

    • Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue.

    More Details

    NCT Number: NCT00721110
    Other IDs: 08-454
    Study URL: https://clinicaltrials.gov/study/NCT00721110
    Last updated: Sep 29, 2023