Ketamine and Magnesium in Post-operative Pain Control in Patients Treated With Opioids

Ketamine

Brief Summary

The goal of this research proposal is to determine if the intraoperative administrative of Ketamine and Magnesium during laparoscopic gynecologic surgery improves postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain.

Intervention / Treatment

  • Ketamine plus Magnesium sulfate (DRUG)
    Patients will receive 2 IV infusions: 1. Ketamine (0.5mg/kg) 2. Magnesium sulfate (2g)
  • Placebo (DRUG)
    Patients will receive 2 IV infusions, both of NaCl 0.9%, as placebos for Ketamine and magnesium sulfate

Condition or Disease

  • Chronic Pain

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years to 80 Years
    Enrollment: 20 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Jul 01, 2017 ACTUAL
    Primary Completion: Feb 27, 2018 ACTUAL
    Completion Date: Feb 27, 2018 ACTUAL
    Study First Posted: Oct 21, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: May 24, 2022

    Sponsors / Collaborators

    Lead Sponsor: Milton S. Hershey Medical Center
    Responsible Party: N/A

    Location

    Hershey, Pennsylvania, USA

    In this randomized control trial, patients' postoperative pain scores will be assessed as scored by the Numeric Rating Score (NRS) system. Intraoperative and postoperative narcotic usage, nausea scores and patients' perception of their quality of recovery via the QoR-40 survey will also be assessed.

    The use of intraoperative Ketamine and Magnesium is predicted to decrease postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain and will overall improve patients' postoperative experience.

    Participant Groups

    • Ketamine 0.5mg/kg IV dose with 2g magnesium IV dose

    • Normal Saline (NaCl 0.9%)

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 80
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    1. Subjects undergoing elective laparoscopic gynecologic surgery
    2. Patients with chronic pelvic pain defined as pain that has persisted for more than 6 months in duration which is localized to the pelvis, anterior abdominal wall, lower back or buttocks and has leads to functional disability or medical care1
    3. Patients requiring opioids daily for \>1 month
    4. Consenting adults age 18-80
    5. American Society of Anesthesiologists (ASA) Physical Status classification II to ASA III

    Exclusion Criteria:

    1. Patient refusal
    2. Chronic Kidney disease (Creatinine\>2)
    3. Patients treated with methadone
    4. Known allergy or adverse effect of ketamine or magnesium
    5. Patient unable to give informed consent
    6. Patient with limited or no English fluency
    7. Uncontrolled hypertension

    Primary Outcomes

    • Patient described pain level on a scale of 0-10

    Secondary Outcomes

    • Dilaudid and Oxycodone in mg.

    • Patient perception of quality of recovery as measured by the QoR-40 Survey

    • Amount of fentanyl used intra-operatively in mcg.

    • Patient described nausea level using 2 questions each with 4 answers with numerical value from 0-3. To calculate the PONV Impact Scale score, the numerical responses to questions 1 and 2 are added to obtain the PONV impact scale score. A PONV Impact Scale score of ≥5 defines clinically important PONV.

    • Number of days the patient was an inpatient in the hospital.

    More Details

    NCT Number: NCT02940509
    Other IDs: STUDY00006048
    Study URL: https://clinicaltrials.gov/study/NCT02940509
    Last updated: Sep 29, 2023