Chronic Pelvic Pain, Endometriosis
Conditions
Keywords
ketamine, central sensitization
Brief summary
The purpose of this research study is to see if ketamine infusion during surgery can decrease pain after surgery. Ketamine is a medication commonly used as part of anesthesia during surgery and is approved by the US FDA. Patients will be randomized to either receive standard anesthesia with OR without ketamine. The surgical procedure will be the same regardless of which group patients are randomized to. After surgery, patients will be asked to rate their pain in the post-operative observation unit and at their two-week post-operative visit. No additional visits are required for participation in this study. The investigators estimate the surveys will take approximately 10 minutes to complete.
Interventions
DRUGketamine
Participants will receive general anesthesia with protocoled ketamine infusion
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* age range 18-89 * ASA classification I-III * outpatient elective laparoscopy for endometriosis
Exclusion criteria
* known allergy or contraindication to ketamine * History of substance use disorder, including alcohol or marijuana use, both current and remote * History of severe psychiatric illness, including schizoaffective disorder, bipolar disorder, psychosis, or decompensated psychiatric condition , excluding anxiety and depression * Current Intraoperative complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in pain as measured by visual analog scale | approximately post-operative day 0 and 14 | A Visual Analog Scale (VAS) is a tool for patients to rate their pain on a 100mm line, where "no pain" is at one end and "worst pain imaginable" is at the other. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative opioid consumption as measured by anesthesia charting | Intraoperatively up to 8 hours | Reported in morphine equivalents |
| change in postoperative pain scores measured by numerical rating scale | approximately postoperative day 0 and 14 | NRS is a simple and widely used pain assessment tool that asks patients to rate their pain intensity on a scale from 0 (no pain) to 10 (severe pain). |
| incidence of postoperative nausea/vomiting as measured by patient report | postoperative day 0 | — |
| change in total analgesic consumption post-surgery as measured by chart review and patient report | approximately postoperative day 0, 1 and 14 | measured in morphine milliequivalents |
| incidence of postoperative delirium as measured by chart review | postoperative day 0 | — |
| change in central sensitization as measured by central sensitization inventory (CSI) score | approximately postoperative day 0 and 14 | The CSI consists of 25 questions, each rated on a 0-4 scale (0 = never, 4 = always). The total score ranges from 0 to 100. Higher scores indicate a greater degree of central sensitization. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdi Cosic, DO
University Hospitals
PRINCIPAL_INVESTIGATORMorgan Cheeks, MD
University Hosptials
Outcome results
None listed