Ketamine in Central Sensitization

Not Applicable

Not yet recruiting

• Conditions: Endometriosis; Chronic Pelvic Pain
• Interventions: Drug: ketamine

• Registration Number: NCT07182032
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Study Start: 2025-11-01
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	ketamine	standard general anesthesia with ketamine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States