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

Phase 1

Terminated

• Conditions: Chronic Pain
• Interventions: Drug: Ketamine plus Magnesium sulfate; Drug: Placebo

• Registration Number: NCT02940509
• Lead Sponsor: Milton S. Hershey Medical Center

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 Timeline

• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-21
• Study Start: 2017-07-01
• Primary Completion: 2018-02-27
• Study Completion: 2018-02-27
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine plus Magnesium sulfate	Ketamine plus Magnesium sulfate	Ketamine 0.5mg/kg IV dose with 2g magnesium IV dose
Placebo	Placebo	Normal Saline (NaCl 0.9%)

Primary Outcome Measures

Name	Time	Method
Post-operative pain score using the Numeric Rating Scale (NRS)	1st 24 hours post-op	Patient described pain level on a scale of 0-10

Secondary Outcome Measures

Name	Time	Method
Post-operative opioid use	24 hours post operative	Dilaudid and Oxycodone in mg.
Recovery Questionnaire	3-5 days post operative	Patient perception of quality of recovery as measured by the QoR-40 Survey
Nausea Scores using PONV Impact Scale Score	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.
Intraoperative fentanyl use	Intraoperative	Amount of fentanyl used intra-operatively in mcg.
Length of Hospital Stay	24 hours Post operative	Number of days the patient was an inpatient in the hospital.

Trial Locations

Locations (1)

Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States