Status:
TERMINATED
The Using Postoperative Ketamine and Exploring the Effect on Endometriosis Pain (UPKEEEP) Study
Lead Sponsor:
NYU Langone Health
Conditions:
Endometriosis
Post Operative Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 adul...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05229653
Start Date
April 12 2022
End Date
October 21 2022
Last Update
March 28 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016