Chronic Pain
Conditions
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.
Interventions
DRUGKetamine plus Magnesium sulfate
Patients will receive 2 IV infusions: 1. Ketamine (0.5mg/kg) 2. Magnesium sulfate (2g)
DRUGPlacebo
Patients will receive 2 IV infusions, both of NaCl 0.9%, as placebos for Ketamine and magnesium sulfate
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain score using the Numeric Rating Scale (NRS) | 1st 24 hours post-op | Patient described pain level on a scale of 0-10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative opioid use | 24 hours post operative | Dilaudid and Oxycodone in mg. |
| Recovery Questionnaire | 3-5 days post operative | Patient perception of quality of recovery as measured by the QoR-40 Survey |
| Intraoperative fentanyl use | Intraoperative | Amount of fentanyl used intra-operatively in mcg. |
| Nausea Scores using PONV Impact Scale Score | 24 hours Post operative | 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. |
| Length of Hospital Stay | 24 hours Post operative | Number of days the patient was an inpatient in the hospital. |
Countries
United States
Outcome results
None listed