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

Phase 1TerminatedNCT02940509

Milton S. Hershey Medical Center20 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Pain

Interventions

Ketamine plus Magnesium sulfateDRUG

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

PlaceboDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Post-operative pain score using the Numeric Rating Scale (NRS)

Patient described pain level on a scale of 0-10

Time frame: 1st 24 hours post-op

Secondary Outcomes

Post-operative opioid use

Dilaudid and Oxycodone in mg.

Time frame: 24 hours post operative

Recovery Questionnaire

Patient perception of quality of recovery as measured by the QoR-40 Survey

Time frame: 3-5 days post operative

Intraoperative fentanyl use

Amount of fentanyl used intra-operatively in mcg.

Time frame: 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.

Time frame: 24 hours Post operative

Length of Hospital Stay

Number of days the patient was an inpatient in the hospital.

Time frame: 24 hours Post operative

Data from ClinicalTrials.gov

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