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

Penn State Health

Status and phase: Terminated; Phase 1

Conditions: Chronic Pain

Treatments: Drug: Placebo; Drug: Ketamine plus Magnesium sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT02940509

STUDY00006048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Ketamine plus Magnesium sulfate

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine plus Magnesium sulfate

Placebo

Placebo Comparator group

Description:

Normal Saline (NaCl 0.9%)

Treatment:

Drug: Placebo