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NMDA Receptor Antagonist
Ketamine for Endometriosis Pain
Phase 1
Recruiting
Led By Kathy Huang, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled to undergo robotic endometriosis removal surgery
Adults, aged 18 to 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative day (pod) 83
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Summary
This trial is testing whether a small dose of ketamine can help reduce pain after surgery in women with chronic pelvic pain from endometriosis. Ketamine works by blocking pain signals in the brain. Ketamine is an old anesthetic agent that has been explored for its efficacy in treating various pain conditions, including chronic pain and postoperative pain.
Who is the study for?
This trial is for adult women aged 18-65 with chronic pelvic pain who are scheduled for robotic endometriosis removal surgery. Participants should be medically stable and willing to follow the study procedures throughout its duration.
What is being tested?
The UPKEEP Study tests if a low dose of ketamine (0.6 mg/kg) can better manage postoperative pain compared to a saline placebo in female patients after robotic endometriosis surgery. It's randomized and single-blinded, meaning participants won't know which treatment they receive.
What are the potential side effects?
Ketamine may cause side effects such as feelings of disconnection from reality, changes in perception, nausea, dizziness, mood swings, or blurred vision. The severity varies among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a robotic surgery to remove endometriosis.
Select...
I am between 18 and 65 years old.
Select...
I have had moderate to severe pelvic pain for more than 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative day (pod) 83
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative day (pod) 83
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pelvic Pain Score on Visual Analogue Scale (VAS)
Secondary study objectives
Change in Opioid Use
Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire
Score on General Anxiety Disorder-7 Screener (GAD-7)
+1 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Low-Dose Ketamine (LDK) Treatment GroupExperimental Treatment1 Intervention
Group II: Control GroupPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for endometriosis primarily involve hormonal therapies and non-hormonal options. Estrogen-progestin contraceptives and progestins like dienogest work by suppressing ovulation and reducing menstrual flow, thereby decreasing the hormonal stimulation of endometrial tissue.
GnRH agonists and antagonists reduce estrogen production, leading to a hypoestrogenic state that shrinks endometrial lesions. NSAIDs are used to manage pain by reducing inflammation.
NMDA receptor antagonists, such as ketamine, offer a different approach by blocking the NMDA receptors involved in pain transmission, which can be particularly beneficial for managing chronic pelvic pain associated with endometriosis. Understanding these mechanisms helps patients and clinicians choose the most appropriate treatment based on symptom severity and individual response.
State of the art, new treatment strategies, and emerging drugs for non-hormonal treatment of endometriosis: a systematic review of randomized control trials.
State of the art, new treatment strategies, and emerging drugs for non-hormonal treatment of endometriosis: a systematic review of randomized control trials.
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
856,173 Total Patients Enrolled
Kathy Huang, MDPrincipal InvestigatorNYU Langone Health