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NMDA Receptor Antagonist

Ketamine for Postoperative Pain (KALPAS Trial)

Phase 3

Recruiting

Led By Lisa Doan, 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

No distant metastases

Undergoing elective breast surgery for oncologic indication as follows: unilateral or bilateral mastectomy, prophylactic mastectomy, +/- lymph node dissection, +/- immediate or delayed reconstruction

Must not have

Unwilling to comply with all study procedures and be available for the duration of the study

Liver or renal insufficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 and 7 days and 1, 3*, 6, and 12 months after surgery

Awards & highlights

Summary

This trial is testing whether or not ketamine can help chronic pain after mastectomy surgery.

Who is the study for?

This trial is for women aged 18 or older undergoing elective breast surgery without distant metastases. They must not have cognitive impairments, liver or renal insufficiency, be pregnant, in another pain study, or have certain medical conditions like uncontrolled hypertension. Participants should not be on specific medications and must have a BMI less than 41.Check my eligibility

What is being tested?

The trial tests if ketamine can reduce chronic pain after mastectomy. It's a placebo-controlled study with three groups: one gets ketamine during/after surgery, another gets a single dose post-surgery, and the last group receives saline as a control.See study design

What are the potential side effects?

Ketamine may cause side effects such as confusion, hallucinations, changes in blood pressure and heart rate, nausea and vomiting. The severity of these side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has not spread to distant parts of my body.

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I am having breast surgery for cancer, which may include removing one or both breasts, lymph nodes, and possibly reconstruction.

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I am a woman aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am willing and able to follow all study procedures and be available for the entire study duration.

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My liver or kidneys are not working properly.

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I have no history of severe heart issues, stroke, head injuries, eye pressure problems, or uncontrolled thyroid disease.

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I am currently taking lamotrigine, alfentanil, physostigmine, or 4-aminopyridine.

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My health is severely impaired, making me a high-risk surgery patient.

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I am scheduled for surgery using tissue flaps from two or more areas.

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I do not speak English or Spanish.

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I have started hormone therapy for transitioning to male.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, and 12 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, and 12 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, and 12 months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

BPI pain severity subscale score

Secondary outcome measures

BPI pain severity and pain interference subscales score

Incidence of PMS: BPI average pain score

PROMIS Depression and Anxiety Short Form Scores

+1 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Arm 1 Continuous ketamine infusion groupActive Control1 Intervention

Continuous ketamine infusion (0.35 mg/kg after induction, followed by 0.25 mg/kg/hr until 2 hours after surgery) plus saline IV dose in post-anesthesia care unit

Group II: Arm 2 Ketamine + Saline groupActive Control1 Intervention

Saline dose and infusion intraoperatively, then single-dose IV ketamine (0.60 mg/kg) in post-anesthesia care unit plus 2 hours of saline administration after surgery

Group III: Arm 3 Placebo groupPlacebo Group1 Intervention

Placebo, Saline dose and infusion intraoperatively, then saline IV dose in post-anesthesia care unit plus 2 hours of saline administration after surgery

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,379 Previous Clinical Trials

847,368 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,748 Previous Clinical Trials

40,958,651 Total Patients Enrolled

Lisa Doan, MDPrincipal InvestigatorNYU Langone Health

5 Previous Clinical Trials

245 Total Patients Enrolled

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05037123 — Phase 3

Chronic Postsurgical Pain Research Study Groups: Arm 3 Placebo group, Arm 1 Continuous ketamine infusion group, Arm 2 Ketamine + Saline group

Chronic Postsurgical Pain Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT05037123 — Phase 3

Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05037123 — Phase 3

Chronic Postsurgical Pain Patient Testimony for trial: Trial Name: NCT05037123 — Phase 3

~47 spots leftby Oct 2024

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