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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02940509
Recruitment Status : Terminated (Change in practice of medicine. There were no longer sufficient patients to enroll in the study that met criteria.)
First Posted : October 21, 2016
Last Update Posted : May 27, 2022
Sponsor:
Information provided by (Responsible Party):
Stacey Duryea, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE October 18, 2016
First Posted Date  ICMJE October 21, 2016
Last Update Posted Date May 27, 2022
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date February 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
Post-operative pain score using the Numeric Rating Scale (NRS) [ Time Frame: 1st 24 hours post-op ]
Patient described pain level on a scale of 0-10
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2016)
Post-operative pain score using the Numeric Rating Scale (NRS) [ Time Frame: 1st 24 hours post-op ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
  • Post-operative opioid use [ Time Frame: 24 hours post operative ]
    Dilaudid and Oxycodone in mg.
  • Recovery Questionnaire [ Time Frame: 3-5 days post operative ]
    Patient perception of quality of recovery as measured by the QoR-40 Survey
  • Intraoperative fentanyl use [ Time Frame: Intraoperative ]
    Amount of fentanyl used intra-operatively in mcg.
  • Nausea Scores using PONV Impact Scale Score [ Time Frame: 24 hours Post operative ]
    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.
  • Length of Hospital Stay [ Time Frame: 24 hours Post operative ]
    Number of days the patient was an inpatient in the hospital.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2016)
  • Post-operative opioid use [ Time Frame: 24 hours post operative ]
    Dilaudid and Oxycodone in mg.
  • Recovery Questionnaire [ Time Frame: 3-5 days post operative ]
    Patient perception of quality of recovery as measured by the QoR-40 Survey
  • Intraoperative fentanyl use [ Time Frame: Intraoperative ]
    Amount of fentanyl used intra-operatively in mcg.
  • Nausea Scores using PONV Impact Scale Score [ Time Frame: 24 hours Post operative ]
  • Length of Hospital Stay [ Time Frame: 24 hours Post operative ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine and Magnesium in Post-operative Pain Control in Patients Treated With Opioids
Official Title  ICMJE The Role of Ketamine and Magnesium in Post-operative Pain Control After Laparoscopic Surgery in Patients With Chronic Pelvic Pain Treated With Opioids: A Double-Blinded Randomized Control Trial.
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Drug: Ketamine plus Magnesium sulfate

    Patients will receive 2 IV infusions:

    1. Ketamine (0.5mg/kg)
    2. Magnesium sulfate (2g)
  • Drug: Placebo
    Patients will receive 2 IV infusions, both of NaCl 0.9%, as placebos for Ketamine and magnesium sulfate
    Other Name: 2 placebo infusions
Study Arms  ICMJE
  • Active Comparator: Ketamine plus Magnesium sulfate
    Ketamine 0.5mg/kg IV dose with 2g magnesium IV dose
    Intervention: Drug: Ketamine plus Magnesium sulfate
  • Placebo Comparator: Placebo
    Normal Saline (NaCl 0.9%)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 14, 2021)
20
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2016)
128
Actual Study Completion Date  ICMJE February 27, 2018
Actual Primary Completion Date February 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02940509
Other Study ID Numbers  ICMJE STUDY00006048
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Stacey Duryea, Milton S. Hershey Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Milton S. Hershey Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stacey Duryea, DO Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP