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

Last updated: March 10, 2025
Sponsor: NYU Langone Health
Overall Status: Terminated

Phase

1

Condition

Endometriosis

Treatment

Placebo

Ketamine

Clinical Study ID

NCT05229653
21-01032
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults, aged 18 to 65 years old

  2. Experiencing chronic pain, defined as experiencing moderate to severe pelvic painfor 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 thestudy.

  5. Subject is medically stable.

Exclusion

Exclusion Criteria:

  1. Cognitive impairment (by history) or clinical signs of altered mental status such asconfusion, amnesia, disorientation, fluctuating levels of alertness, etc. that mayinterference 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, headtrauma, 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 arecontraindicated

  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 toNYULH in English.

Study Design

Total Participants: 1
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
April 12, 2022
Estimated Completion Date:
October 21, 2022

Connect with a study center

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

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