Ketamine for Endometriosis Pain

Overseen By Vaishali Shah

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NYU Langone Health

Must not be taking: Lamotrigine, Alfentanil, others

Disqualifiers: Cognitive impairment, Schizophrenia, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kathy Huang, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for a robotic surgery to remove endometriosis.

You are in good overall health.

I am willing and able to follow the study rules and attend all appointments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subanesthetic dose of ketamine or placebo postoperatively

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, anxiety, depression, and opioid use

12 weeks

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Ketamine
• Placebo

Trial Overview 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.

Participant Groups

Group I: Low-Dose Ketamine (LDK) Treatment Group Experimental Treatment 1 Intervention

Group II: Control Group Placebo Group 1 Intervention

Ketamine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in European Union as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in United States as Spravato for:

• Treatment-resistant depression

Approved in European Union as Spravato for:

• Treatment-resistant depression

Approved in Canada as Spravato for:

• Treatment-resistant depression

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+