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

NCT05229653 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 21-01032
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Pelvic Pain Score on Visual Analogue Scale (VAS)

  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.

  Baseline

• Pelvic Pain Score on Visual Analogue Scale (VAS)

  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.

  Post-Operative Day (POD) 1

• Pelvic Pain Score on Visual Analogue Scale (VAS)

  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.

  Post-Operative Day (POD) 27

• Pelvic Pain Score on Visual Analogue Scale (VAS)

  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.

  Post-Operative Day (POD) 55

• Pelvic Pain Score on Visual Analogue Scale (VAS)

  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.

  Post-Operative Day (POD) 83

Secondary Outcomes (16)

• Score on General Anxiety Disorder-7 Screener (GAD-7)

  Baseline

• Score on General Anxiety Disorder-7 Screener (GAD-7)

  Post-Operative Day (POD) 1

• Score on General Anxiety Disorder-7 Screener (GAD-7)

  Post-Operative Day (POD) 27

• Score on General Anxiety Disorder-7 Screener (GAD-7)

  Post-Operative Day (POD) 55

• Score on General Anxiety Disorder-7 Screener (GAD-7)

  Post-Operative Day (POD) 83

Study Arms (2)

Low-Dose Ketamine (LDK) Treatment Group

EXPERIMENTAL

Drug: Ketamine

Control Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ketamine 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.

Low-Dose Ketamine (LDK) Treatment Group

Placebo 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.

Control Group

Eligibility Criteria

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

You may qualify if:

• Adults, aged 18 to 65 years old
• Experiencing chronic pain, defined as experiencing moderate to severe pelvic pain for greater than 6 months
• Scheduled to undergo robotic endometriosis removal surgery
• Willing to comply with all study procedures and be available for the duration of the study.
• Subject is medically stable.

You may not qualify if:

• 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.
• Past ketamine or phencyclidine misuse or abuse
• Schizophrenia or history of psychosis
• Known sensitivity or allergy to ketamine
• Liver or renal insufficiency.
• 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
• Pregnancy or nursing women
• Currently participating in another pain interventional trial
• Unwillingness to give informed consent
• Non-English-speaking patients as the EHP-30 instrument has only been licensed to NYULH in English.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Endometriosis; Pain, Postoperative

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kathy Huang, MD
• Organization: NYU Langone Health

Kathy.Huang@nyulangone.org

(212) 545-5400

Study Officials

• Kathy Huang, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 8, 2022
• Study Start: April 12, 2022
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Kathy.haung@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)