Opioid vs. Opioid-free Anesthesia for Hip Arthroscopy

Ketamine

Brief Summary

The purpose of this study is to determine whether an infusion of lidocaine/ketamine compared to fentanyl is equivalent in anesthesia effectiveness and can help reduce the incidence of postoperative nausea and vomiting in patients undergoing elective hip arthroscopy surgery.

Intervention / Treatment

  • Lidocaine/ ketamine (DRUG)
    N/A
  • Fentanyl (DRUG)
    N/A

Condition or Disease

  • Opioid Free Anaesthesia
  • Postoperative Analgesia

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 53 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

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

    Clinical Trial Dates

    Start date: May 01, 2014
    Primary Completion: Aug 01, 2015 ACTUAL
    Completion Date: Aug 01, 2015 ACTUAL
    Study First Posted: May 29, 2014 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 24, 2015

    Sponsors / Collaborators

    Lead Sponsor: Clinica Santa Maria
    Responsible Party: N/A

    Location

    Santiago, Chile

    Participant Groups

    • lidocaine 1mg/Kg bolus, followed by continuous infusion 1 mg/kg/h AND ketamine 1mg/Kg bolus followed by continuous infusion 1 mg/kg/h

    • iv fentanyl, 3ug/kg bolus

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * 18-65 years old
    * ASA I-II
    * Undergoing elective hip arthroscopy

    Exclusion Criteria:

    * Known allergies to study drugs
    * Opioid use 1 month prior to surgery
    * BMI \>30
    * Unable to comprehend visual analog scale

    Primary Outcomes
    • Incidence of postoperative nausea and vomiting in the recovery room first 3 postoperative hours
    • morphine consumption in the recovery room first 3 postopeartive hours
    Secondary Outcomes
    • Incidence of postoperative nausea and vomiting on day 1 1st postoperative day
    • Anesthestic gas consumption intraoperative

    More Details

    NCT Number: NCT02150161
    Other IDs: 56csm2014001
    Study URL: https://clinicaltrials.gov/study/NCT02150161
    Last updated: Sep 29, 2023