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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: Ketamine plus Magnesium sulfate; Drug: Placebo

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: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ketamine plus Magnesium sulfate; Ketamine 0.5mg/kg IV dose with 2g magnesium IV dose	Drug: Ketamine plus Magnesium sulfate; Patients will receive 2 IV infusions: Ketamine (0.5mg/kg); Magnesium sulfate (2g)
Placebo Comparator: Placebo; Normal Saline (NaCl 0.9%)	Drug: Placebo; Patients will receive 2 IV infusions, both of NaCl 0.9%, as placebos for Ketamine and magnesium sulfate; Other Names: 2 placebo infusions

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative opioid use	Dilaudid and Oxycodone in mg.	24 hours post operative
Recovery Questionnaire	Patient perception of quality of recovery as measured by the QoR-40 Survey	3-5 days post operative
Intraoperative fentanyl use	Amount of fentanyl used intra-operatively in mcg.	Intraoperative
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.	24 hours Post operative
Length of Hospital Stay	Number of days the patient was an inpatient in the hospital.	24 hours Post operative

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Stacey Duryea, DO, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): February 27, 2018
• Study Completion (Actual): February 27, 2018

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Ketamine; Magnesium Sulfate
• Other Study ID Numbers: STUDY00006048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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