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

Primary Purpose

Chronic Pain

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ketamine plus Magnesium sulfate
Placebo
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ketamine plus Magnesium sulfate

Placebo

Arm Description

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

Normal Saline (NaCl 0.9%)

Outcomes

Primary Outcome Measures

Post-operative pain score using the Numeric Rating Scale (NRS)
Patient described pain level on a scale of 0-10

Secondary Outcome Measures

Post-operative opioid use
Dilaudid and Oxycodone in mg.
Recovery Questionnaire
Patient perception of quality of recovery as measured by the QoR-40 Survey
Intraoperative fentanyl use
Amount of fentanyl used intra-operatively in mcg.
Nausea Scores using PONV Impact Scale Score
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
Number of days the patient was an inpatient in the hospital.

Full Information

First Posted
October 18, 2016
Last Updated
May 24, 2022
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02940509
Brief Title
Ketamine and Magnesium in Post-operative Pain Control in Patients Treated With Opioids
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Change in practice of medicine. There were no longer sufficient patients to enroll in the study that met criteria.
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
February 27, 2018 (Actual)
Study Completion Date
February 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine plus Magnesium sulfate
Arm Type
Active Comparator
Arm Description
Ketamine 0.5mg/kg IV dose with 2g magnesium IV dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal Saline (NaCl 0.9%)
Intervention Type
Drug
Intervention Name(s)
Ketamine plus Magnesium sulfate
Intervention Description
Patients will receive 2 IV infusions: Ketamine (0.5mg/kg) Magnesium sulfate (2g)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
2 placebo infusions
Intervention Description
Patients will receive 2 IV infusions, both of NaCl 0.9%, as placebos for Ketamine and magnesium sulfate
Primary Outcome Measure Information:
Title
Post-operative pain score using the Numeric Rating Scale (NRS)
Description
Patient described pain level on a scale of 0-10
Time Frame
1st 24 hours post-op
Secondary Outcome Measure Information:
Title
Post-operative opioid use
Description
Dilaudid and Oxycodone in mg.
Time Frame
24 hours post operative
Title
Recovery Questionnaire
Description
Patient perception of quality of recovery as measured by the QoR-40 Survey
Time Frame
3-5 days post operative
Title
Intraoperative fentanyl use
Description
Amount of fentanyl used intra-operatively in mcg.
Time Frame
Intraoperative
Title
Nausea Scores using PONV Impact Scale Score
Description
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.
Time Frame
24 hours Post operative
Title
Length of Hospital Stay
Description
Number of days the patient was an inpatient in the hospital.
Time Frame
24 hours Post operative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects undergoing elective laparoscopic gynecologic surgery 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 Patients requiring opioids daily for >1 month Consenting adults age 18-80 American Society of Anesthesiologists (ASA) Physical Status classification II to ASA III Exclusion Criteria: Patient refusal Chronic Kidney disease (Creatinine>2) Patients treated with methadone Known allergy or adverse effect of ketamine or magnesium Patient unable to give informed consent Patient with limited or no English fluency Uncontrolled hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey Duryea, DO
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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