Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery

Ketamine

Brief Summary

This study has been designed as a controlled clinical trial to evaluate the efficacy of brief lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when added to conventional opioid therapy following major spine surgery, as well as to evaluate the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine intraoperative neurophysiology during spine surgery in adults and determine whether this infusion protocol is compatible with intraoperative neurophysiology on spine surgery patients. If one or more of the approaches is confirmed as efficacious and safe, it could have a significant impact on the routine management of postoperative pain in this context.

Intervention / Treatment

  • Lidocaine (DRUG)
    N/A
  • Ketamine (DRUG)
    N/A
  • Saline (OTHER)
    N/A

Condition or Disease

  • Postoperative Pain

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 46 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Apr 01, 2011
    Primary Completion: Jan 01, 2013 ACTUAL
    Completion Date: Jan 01, 2013 ACTUAL
    Study First Posted: Nov 13, 2013 ESTIMATED
    Results First Posted: May 15, 2017 ACTUAL
    Last Updated: Apr 28, 2017

    Sponsors / Collaborators

    Lead Sponsor: Beth Israel Medical Center
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    New York, New York, USA

    Participant Groups

    • Ketamine infused at 0.25 mg/kg/hour.

    • Lidocaine infused at 0.5 mg/kg/hour.

    • Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour

    • Placebo (saline) given to compare usual treatment against active agents in post operative pain management.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    Male and Female \>/= 18 years of age Patients undergoing first-time fusion surgery or surgery to revise a prior fusion Able to read, write and speak in English, and able to give informed consent for the study

    Exclusion Criteria:

    Any disease associated with major organ dysfunction renal dysfunction hepatic dysfunction cardiac dysfunction

    Primary Outcomes

    • The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).

    More Details

    NCT Number: NCT01983020
    Other IDs: IRB 073-10
    Study URL: https://clinicaltrials.gov/study/NCT01983020
    Last updated: Sep 29, 2023