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

Phase 1

Terminated

• Conditions: Endometriosis; Post Operative Pain
• Interventions: Drug: Placebo; Drug: Ketamine

• Registration Number: NCT05229653
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-08
• Study Start: 2022-04-12
• Primary Completion: 2022-10-21
• Study Completion: 2022-10-21
• Status Verified: 2025-03
• Results First Submitted: 2025-03-10
• Results First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Results First Posted: 2025-03-28
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	-
Low-Dose Ketamine (LDK) Treatment Group	Ketamine	-

Primary Outcome Measures

Name	Time	Method
Pelvic Pain Score on Visual Analogue Scale (VAS)	Post-Operative Day (POD) 83	VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.

Secondary Outcome Measures

Name	Time	Method
Score on General Anxiety Disorder-7 Screener (GAD-7)	Post-Operative Day (POD) 83	GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Score on Montgomery-Åsberg Depression Rating Scale (MADRS)	Post-Operative Day (POD) 83	MADRS is a 10-item diagnostic questionnaire that psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a 0-6 scale, resulting in a total score range of 0-60. The higher the score, the more severe the depression.
Change in Opioid Use	Baseline, Post-Operative Day (POD) 83	Opioid use will be assessed through medical records and subject reports. Assessment of opiate use will be used to determine the opiate-sparing effects of the study drug.
Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire	Post-Operative Day (POD) 83	A Health-Related Quality of Life (HRQoL) patient self-report tool used to measure the wide range of effects that endometriosis can have on patients' lives, including work, relationship with child/children, sexual relationship, feelings about medical profession, feelings about treatment, and feelings about infertility. The EHP-30 questions are asked regarding endometriosis in the previous 4 weeks and are answered on a 5-point Likert scale, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=always. Raw scores for the questions within a scale are summed and transformed to a 0-100 scale, with higher scores indicating worse HRQoL.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States