Ketamine for Pelvic Pain

Overseen By Adi Cosic, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Substance use disorder, Severe psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Intraoperative up to 8 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding ketamine to standard anesthesia can reduce post-surgery pain for individuals with endometriosis. Ketamine, typically used during surgery to induce sleep, will be administered to participants randomly assigned to receive either regular anesthesia or regular anesthesia with ketamine during their laparoscopic surgery. The trial seeks participants undergoing outpatient laparoscopic surgery for endometriosis who can complete short surveys about their post-surgery pain. As a Phase 4 trial, this research explores how the already FDA-approved and effective treatment benefits a broader range of patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for ketamine?

Research has shown that ketamine is generally safe in medical settings such as surgery. The FDA has approved ketamine for use as anesthesia, indicating it has undergone safety testing. In studies where ketamine provided pain relief, many patients reported improvement without serious side effects. However, recreational use of ketamine can cause bladder problems, though this is not typically a concern in a controlled medical environment. Overall, ketamine is considered safe for surgical use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for pelvic pain, which often include medications like NSAIDs and opioids, ketamine offers a novel approach by acting on the brain's glutamate system. This mechanism is different from typical pain relievers, which usually target inflammatory pathways or opioid receptors. Researchers are excited about ketamine because it might provide rapid pain relief and potentially help people who haven't found success with other treatments. Additionally, ketamine's unique action on the nervous system could offer new insights into managing chronic pain conditions.

What evidence suggests that ketamine might be an effective treatment for pelvic pain?

Research shows that ketamine can help reduce pain after surgery. Studies have found that ketamine provides strong pain relief during administration, and some patients continue to feel better even after treatment ends. In this trial, one group will receive standard general anesthesia with ketamine, potentially offering quick relief for pelvic pain that may persist for weeks or months. Another group will receive standard general anesthesia without ketamine. Ketamine is well-known and approved for medical use as part of anesthesia in surgeries. ^{2 5 6 7 8}

Who Is on the Research Team?

Morgan Cheeks, MD

Principal Investigator

University Hosptials

Adi Cosic, DO

Principal Investigator

University Hospitals

Are You a Good Fit for This Trial?

This trial is for individuals undergoing surgery who experience conditions like endometrial thinning, endometriosis, or pelvic pain. Participants must be eligible for the surgical procedure and able to provide feedback on their pain levels after surgery.

Inclusion Criteria

ASA classification I-III

I am between 18 and 89 years old.

I am scheduled for a laparoscopy to treat endometriosis as an outpatient.

Exclusion Criteria

Known allergy or contraindication to ketamine

History of substance use disorder, including alcohol or marijuana use, both current and remote

History of severe psychiatric illness, including schizoaffective disorder, bipolar disorder, psychosis, or decompensated psychiatric condition (excluding anxiety and depression)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo surgery with standard anesthesia, with or without ketamine infusion

Intraoperative up to 8 hours

Post-operative Observation

Patients rate their pain in the post-operative observation unit

Immediate post-operative period

Follow-up

Participants are monitored for pain and analgesic consumption at their two-week post-operative visit

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ketamine

Trial Overview

The study tests if adding ketamine to standard anesthesia can reduce post-surgery pain. Patients are randomly assigned to receive either just the usual anesthesia or with additional ketamine. Pain assessments occur right after surgery and at a two-week follow-up.

How Is the Trial Designed?

Group I: Ketamine Experimental Treatment 1 Intervention

standard general anesthesia with ketamine

Group II: Control Active Control 1 Intervention

standard general anesthesia without ketamine

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4014022/

Ketamine for chronic pain: risks and benefits - PMC

Current data on short term infusions indicate that ketamine produces potent analgesia during administration only, while three studies on the effect of prolonged ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05229653

The Using Postoperative Ketamine and Exploring the Effect ...

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 ...

3.

consultqd.clevelandclinic.org

consultqd.clevelandclinic.org/low-dose-ketamine-protocol-for-chronic-refractory-pain

Low-Dose Ketamine Protocol for Chronic Refractory Pain

From baseline to last infusion, 20.3% to 46.4% of patients experienced clinically meaningful improvement on patient reported outcomes; those ...

4.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2805027

Depression and Pain Relief With Ketamine in Patients ...

In this cohort study of 329 patients with treatment-resistant pain, pretreatment depression was the only mediator of chronic pain relief with ketamine.

5.

pelvicpainrehab.com

pelvicpainrehab.com/blog/ketamine-may-offer-rapid-relief-persistent-pelvic-pain/

Ketamine May Offer Rapid Relief from Persistent Pelvic Pain

The beneficial effects of ketamine can last for weeks or months depending on the severity and chronicity of the pain and follow-up treatments ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9476224/

Ketamine-Induced Cystitis: A Comprehensive Review of ...

Regular ketamine consumption has been shown to increase the risk of cystitis symptoms by 3- to 4-fold, and cessation of ketamine use is usually associated with ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0278584624002811

Comparative safety of prescribed Esketamine and ...

Comparative studies on esketamine and ketamine's urological safety profiles show esketamine has lower or comparable risks of renal and urinary disorders.

8.

ucc-today.com

ucc-today.com/journals/issue/launch-edition/article/ketamine-bladders-what-community-nurses-should-know-ucct

Ketamine bladders: what community nurses should know

- Using ketamine at least three times a week over a period of two years has been shown to result in altered bladder function, with some patients complaining of ...