Clinical trial NCT05229653: The Using Postoperative Ketamine and Exploring the Effect on Endometriosis Pain (UPKEEEP) Study
Official title: Phase I Randomized, Single-blind, Placebo-controlled, Single-center Study of the Effect of Postoperative Administration of Single Dose Ketamine on Pain and Recovery After Robotic Removal of Endometriosis in Patients With Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Endometriosis
Post Operative Pain
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pelvic Pain Score on Visual Analogue Scale (VAS)
timeFrame: Baseline
measure: Pelvic Pain Score on Visual Analogue Scale (VAS)
timeFrame: Post-Operative Day (POD) 1
measure: Pelvic Pain Score on Visual Analogue Scale (VAS)
timeFrame: Post-Operative Day (POD) 27
measure: Pelvic Pain Score on Visual Analogue Scale (VAS)
timeFrame: Post-Operative Day (POD) 55
measure: Pelvic Pain Score on Visual Analogue Scale (VAS)
timeFrame: Post-Operative Day (POD) 83
Secondary outcomes:
measure: Score on General Anxiety Disorder-7 Screener (GAD-7)
timeFrame: Baseline
measure: Score on General Anxiety Disorder-7 Screener (GAD-7)
timeFrame: Post-Operative Day (POD) 1
measure: Score on General Anxiety Disorder-7 Screener (GAD-7)
timeFrame: Post-Operative Day (POD) 27
measure: Score on General Anxiety Disorder-7 Screener (GAD-7)
timeFrame: Post-Operative Day (POD) 55
measure: Score on General Anxiety Disorder-7 Screener (GAD-7)
timeFrame: Post-Operative Day (POD) 83
measure: Score on Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Baseline
measure: Score on Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Post-Operative Day (POD) 1
measure: Score on Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Post-Operative Day (POD) 27
measure: Score on Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Post-Operative Day (POD) 55
measure: Score on Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Post-Operative Day (POD) 83
measure: Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire
timeFrame: Baseline
measure: Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire
timeFrame: Post-Operative Day (POD) 1
measure: Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire
timeFrame: Post-Operative Day (POD) 27
measure: Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire
timeFrame: Post-Operative Day (POD) 55
measure: Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire
timeFrame: Post-Operative Day (POD) 83
measure: Change in Opioid Use
timeFrame: Baseline, Post-Operative Day (POD) 83
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Kathy Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: