Dose-response of Ketamine in Patient Controlled Analgesia in Orthopaedic Surgery Patients

Ketamine

Brief Summary

To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation

Intervention / Treatment

  • Oxycodone (DRUG)
    Current clinical practice, used as a control in this study
  • S-Ketamine 0.25 (DRUG)
    dosage
  • S-Ketamine 0.5 (DRUG)
    dosage
  • S-Ketamine 0.75 (DRUG)
    dosage

Condition or Disease

  • Pain, Postoperative

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 20 Years to 75 Years
    Enrollment: 100 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

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

    Clinical Trial Dates

    Start date: Feb 01, 2017 ACTUAL
    Primary Completion: Nov 03, 2019 ACTUAL
    Completion Date: Dec 05, 2019 ACTUAL
    Study First Posted: Dec 15, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Dec 10, 2019

    Sponsors / Collaborators

    Lead Sponsor: Turku University Hospital
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Turku, Southwest Finland, Finland

    Participant Groups

    • Oxycodone 1 mg / ml alone

    • Oxycodone 1 mg / ml + S-ketamine 0.25 mg / ml (ratio 1:0.25)

    • Oxycodone 1 mg / ml + S-ketamine 0.5 mg / ml (ratio 1:0.5)

    • Oxycodone 1 mg / ml + S-ketamine 0.75 mg / ml (ratio 1:0.75)

    Eligibility Criteria

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

    Inclusion Criteria:

    * 20 - 75 years of age
    * Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
    * Written informed consent from the participating patient

    Exclusion Criteria:

    * A previous history of intolerance to the study drug or related compounds and additives
    * Concomitant drug therapy with opioids or strong CYP3A4 or CYP2B6 inductor(s) or inhibitor(s) 2 weeks prior to study.
    * Patients younger than 20 years and older than 75 years.
    * BMI \> 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
    * Existing significant liver or kidney disease
    * History of ischemic heart disease or conduction disturbance
    * History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
    * Donation of blood for 4 weeks prior and during the study.

    Primary Outcomes

    • Change from baseline opioid consumption (mg) postoperatively at 24 and 72 hours

    Secondary Outcomes

    • Change from baseline NRS value postoperatively at 24 and 72 hours

    More Details

    NCT Number: NCT02994173
    Acronym: DoseRespKeta
    Other IDs: T281/2016
    Study URL: https://clinicaltrials.gov/study/NCT02994173
    Last updated: Sep 29, 2023