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

Chronic Pain Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02940509
• Other study ID #: STUDY00006048
• Status: Terminated
• Phase: Phase 1
• Start date: July 1, 2017
• Est. completion date: February 27, 2018

Study information

• Verified date: May 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: February 27, 2018
• Est. primary completion date: February 27, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Postoperative

Intervention

Drug:
• Ketamine plus Magnesium sulfate
Patients will receive 2 IV infusions: Ketamine (0.5mg/kg) Magnesium sulfate (2g)
• Placebo
Patients will receive 2 IV infusions, both of NaCl 0.9%, as placebos for Ketamine and magnesium sulfate

Locations

Country	Name	City	State
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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