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

NCT02940509 | Terminated Phase 1 FDA Drug

• 1 other identifier: STUDY00006048
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Post-operative opioid use

  24 hours post operative

• Recovery Questionnaire

  3-5 days post operative

• Intraoperative fentanyl use

  Intraoperative

• Nausea Scores using PONV Impact Scale Score

  24 hours Post operative

• Length of Hospital Stay

  24 hours Post operative

Study Arms (2)

Ketamine plus Magnesium sulfate

ACTIVE COMPARATOR

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

Drug: Ketamine plus Magnesium sulfate

Placebo

PLACEBO COMPARATOR

Normal Saline (NaCl 0.9%)

Drug: Placebo

Interventions

Ketamine plus Magnesium sulfate DRUG

Patients will receive 2 IV infusions: 1. Ketamine (0.5mg/kg) 2. Magnesium sulfate (2g)

Ketamine plus Magnesium sulfate

Placebo DRUG

Patients will receive 2 IV infusions, both of NaCl 0.9%, as placebos for Ketamine and magnesium sulfate

Also known as: 2 placebo infusions

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Ketamine; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Stacey Duryea, DO

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 21, 2016
• Study Start: July 1, 2017
• Primary Completion: February 27, 2018
• Study Completion: February 27, 2018
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)