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

Study Overview
=================
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.

Official Title
-----------------
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.

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Drug: Ketamine plus Magnesium sulfate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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