The Using Postoperative Ketamine and Exploring the Effect on Endometriosis Pain (UPKEEEP) Study

NCT ID: NCT05229653

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2022-10-21

Brief Summary

This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6 mg/kg) of ketamine versus placebo (saline) on postoperative pain and pain on adult female chronic pelvic pain patients undergoing robotic removal of endometriosis. The objective of the study is to explore the effect of a sub anesthetic dose of ketamine (0.6 mg/kg) vs. saline control on postoperative pain and recovery in chronic pelvic pain patients who have undergone robotic removal of endometriosis.

Conditions

Endometriosis; Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low-Dose Ketamine (LDK) Treatment Group

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Participants in this arm will receive intravenously (IV) ketamine (0.6 mg/kg) while recovering in the post anesthesia care unit (PACU) on the day of the surgery after subject has been deemed to be stable (hemodynamically stable, awake). The study physician will administer the study intervention via an intravenous pump to deliver 0.6 mg/kg ketamine over at least 30 minutes.

Control Group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants in this arm will receive intravenously (IV) matching equal dose of placebo while recovering in the post anesthesia care unit (PACU) on the day of the surgery after subject has been deemed to be stable (hemodynamically stable, awake). The study physician will administer the study intervention via an intravenous pump to deliver equal volume saline over at least 30 minutes.

Interventions

Ketamine

Participants in this arm will receive intravenously (IV) ketamine (0.6 mg/kg) while recovering in the post anesthesia care unit (PACU) on the day of the surgery after subject has been deemed to be stable (hemodynamically stable, awake). The study physician will administer the study intervention via an intravenous pump to deliver 0.6 mg/kg ketamine over at least 30 minutes.

Intervention Type: DRUG

Placebo

Participants in this arm will receive intravenously (IV) matching equal dose of placebo while recovering in the post anesthesia care unit (PACU) on the day of the surgery after subject has been deemed to be stable (hemodynamically stable, awake). The study physician will administer the study intervention via an intravenous pump to deliver equal volume saline over at least 30 minutes.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adults, aged 18 to 65 years old

2. Experiencing chronic pain, defined as experiencing moderate to severe pelvic pain for greater than 6 months

3. Scheduled to undergo robotic endometriosis removal surgery

4. Willing to comply with all study procedures and be available for the duration of the study.

5. Subject is medically stable.

Exclusion Criteria

1. Cognitive impairment (by history) or clinical signs of altered mental status such as confusion, amnesia, disorientation, fluctuating levels of alertness, etc. that may interference with adherence to study procedures and/or participant safety.

2. Past ketamine or phencyclidine misuse or abuse

3. Schizophrenia or history of psychosis

4. Known sensitivity or allergy to ketamine

5. Liver or renal insufficiency.

6. History of uncontrolled hypertension, chest pain, cardiac arrythmia, stroke, head trauma, intracranial mass or hemorrhage or pressure, glaucoma, acute globe injury, uncontrolled thyroid disease, porphyria, or any other contraindication to ketamine. Use of lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are contraindicated

7. Pregnancy or nursing women

8. Currently participating in another pain interventional trial

9. Unwillingness to give informed consent

10. Non-English-speaking patients as the EHP-30 instrument has only been licensed to NYULH in English.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathy Huang, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

21-01032

Identifier Type: -

Identifier Source: org_study_id