Preemptive Low-dose Epidural Ketamine for Preventing Chronic Post-thoracotomy Pain

Ketamine

Brief Summary

Chronic post-thoracotomy pain is the most common long-term complication that occurs after a thoracotomy with a reported incidence of up to 80%. While thoracic epidural analgesia has become the mainstay for managing acute post-thoracotomy pain, its effect on the chronic post-thoracotomy pain seems questionable. The objective of this prospective, double-blinded, randomized, controlled trial was to assess the effect of preemptive low-dose epidural ketamine in addition to preemptive thoracic epidural analgesia on the incidence of chronic post-thoracotomy pain.

Intervention / Treatment

  • Ketamine (DRUG)
    N/A
  • ketamine free (DRUG)
    N/A

Condition or Disease

  • Chronic Post-thoracotomy Pain

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 19 Years to 81 Years
    Enrollment: 209 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Apr 01, 2004
    Primary Completion: Jun 01, 2005 ACTUAL
    Completion Date: Jun 01, 2005 ACTUAL
    Study First Posted: Nov 20, 2009 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 19, 2009

    Sponsors / Collaborators

    Lead Sponsor: Seoul National University Hospital
    Responsible Party: N/A
    No responsible party listed

    Location

    South Korea
    Seoul, South Korea

    Participant Groups

    • epidural ketamine added to the patient controlled epidural analgesia regimen

    • epidural ketamine NOT added to the patient controlled epidural analgesia regimen

    Eligibility Criteria

    Sex: All
    Minimum Age: 19
    Maximum Age: 81
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Patients undergoing surgery with a thoracotomy incision

    Exclusion Criteria:

    * history of previous thoracic surgery, chronic pain, psychiatric disease, cardiac or vascular disease, neurologic deficits, or contraindications to epidural catheterization such as coagulopathy, or localized or systemic infection

    Primary Outcomes
    • Incidence of pain 3 months after surgery 3 months after surgery

    More Details

    NCT Number: NCT01017393
    Other IDs: JHBahk_epidural ketamine PTPS
    Study URL: https://clinicaltrials.gov/study/NCT01017393
    Last updated: Sep 29, 2023