Ketamine in Central Sensitization

NCT07182032 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY20250700
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Chronic Pelvic Pain

Keywords

ketamine; central sensitization

Outcome Measures

Primary Outcomes (1)

• change in pain as measured by visual analog scale

  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.

  approximately post-operative day 0 and 14

Secondary Outcomes (6)

• Intraoperative opioid consumption as measured by anesthesia charting

  Intraoperatively up to 8 hours

• change in postoperative pain scores measured by numerical rating scale

  approximately postoperative day 0 and 14

• 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

• incidence of postoperative delirium as measured by chart review

  postoperative day 0

Study Arms (2)

Control

NO INTERVENTION

standard general anesthesia without ketamine

Ketamine

EXPERIMENTAL

standard general anesthesia with ketamine

Drug: ketamine

Interventions

ketamine DRUG

Participants will receive general anesthesia with protocoled ketamine infusion

Ketamine

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age range 18-89
• ASA classification I-III
• outpatient elective laparoscopy for endometriosis

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Adi Cosic, DO

  University Hospitals

  PRINCIPAL INVESTIGATOR

• Morgan Cheeks, MD

  University Hosptials

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adi Cosic, MD

CONTACT

216-844-2273; adi.cosic2@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 19, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)