Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery

Ketamine

Brief Summary

The objective of this trial is to determine whether an opioid-free general anesthetic (OFA) technique utilizing ketamine, dexmedetomidine, and lidocaine infusions can help reduce postoperative pain in opiate-dependent chronic pain patients (CPPs) undergoing spine surgery when compared with traditional opioid-containing techniques. It is expected that this OFA regimen will have a measurable reduction on postoperative opioid consumption and pain scores in CPPs.

Intervention / Treatment

  • Opioid-free general anesthetic (DRUG)
    An opioid-free general anesthetic technique utilizing dexmedetomidine, ketamine, and lidocaine infusions
  • Traditional general anesthetic (DRUG)
    Traditional general anesthetic technique utilizing sufentanil, fentanyl or remifentanil

Condition or Disease

  • Chronic Pain
  • Anesthesia

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 30 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    SINGLE:
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 02, 2016 ACTUAL
    Primary Completion: Sep 01, 2020 ESTIMATED
    Completion Date: Sep 01, 2020 ESTIMATED
    Study First Posted: Apr 27, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Mar 24, 2020

    Sponsors / Collaborators

    Lead Sponsor: Ben Lim
    Responsible Party: Ben Lim

    Location

    Saskatoon, Saskatchewan, Canada

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

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

    Inclusion Criteria:

    * Chronic pain \> 6 months, opiate-using patients scheduled for thoracic or lumbar spinal surgery

    Exclusion Criteria:

    * Pregnant or breastfeeding women, significant hepatic, renal or cardiac disease, allergy to any of the study drugs, inability to consent, respond to pain assessments or use the patient controlled analgesia device

    Primary Outcomes
    • Quantified opioid-consumption 48 hours following surgery
    Secondary Outcomes
    • Visual analogue scale (VAS) pain scores 48 hours following surgery
    • Time of stay in post-anesthetic care unit (PACU) up to 5 hours following surgery
    • Incidence of adverse events 48 hours following surgery

    More Details

    NCT Number: NCT02752477
    Other IDs: BIO15-253
    Study URL: https://clinicaltrials.gov/study/NCT02752477
    Last updated: Sep 29, 2023