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

NYU Langone Health

Status and phase: Terminated; Phase 1

Conditions: Endometriosis; Post Operative Pain

Treatments: Drug: Ketamine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05229653

21-01032

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups, including a placebo group

Low-Dose Ketamine (LDK) Treatment Group

Experimental group

Treatment:

Drug: Ketamine

Control Group

Placebo Comparator group

Treatment:

Drug: Placebo