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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, and 12 months after surgery
Awards & highlights
KALPAS Trial 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.
KALPAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not spread to distant parts of my body.
Select...
I am having breast surgery for cancer, which may include removing one or both breasts, lymph nodes, and possibly reconstruction.
Select...
I am a woman aged 18 or older.
KALPAS Trial 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
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 moreKALPAS 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
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
838,976 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,923,932 Total Patients Enrolled
Lisa Doan, MDPrincipal InvestigatorNYU Langone Health
5 Previous Clinical Trials
245 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has not spread to distant parts of my body.I am willing and able to follow all study procedures and be available for the entire study duration.You have a body mass index (BMI) of 41 or higher.My liver or kidneys are not working properly.I have no history of severe heart issues, stroke, head injuries, eye pressure problems, or uncontrolled thyroid disease.I am currently taking lamotrigine, alfentanil, physostigmine, or 4-aminopyridine.I am having breast surgery for cancer, which may include removing one or both breasts, lymph nodes, and possibly reconstruction.My health is severely impaired, making me a high-risk surgery patient.I am a woman aged 18 or older.I am scheduled for surgery using tissue flaps from two or more areas.I do not speak English or Spanish.I have started hormone therapy for transitioning to male.You are allergic to ketamine.You have been diagnosed with schizophrenia or have a history of experiencing psychosis.You have a history of misusing or abusing ketamine or phencyclidine.You have had post-traumatic stress disorder in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 3 Placebo group
- Group 2: Arm 1 Continuous ketamine infusion group
- Group 3: Arm 2 Ketamine + Saline group
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Postsurgical Pain Patient Testimony for trial: Trial Name: NCT05037123 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given their stamp of approval to Arm 1 Continuous ketamine infusion group?
"While Arm 1 of the Continuous ketamine infusion group is considered safe, there is only some data supporting efficacy. This falls in line with it being a Phase 3 trial."
Answered by AI
Are there other ongoing studies that use a similar treatment plan involving arm 1 and continuous ketamine infusions?
"The first study observing the effects of a continuous ketamine infusion was conduced in 2013 at Cedars Sinai Medical Center. As of right now, there have been 18657 completed trials worldwide. Currently, 114 studies are recruiting patients with many based in Houston, Texas."
Answered by AI
How many test locations are currently conducting this research?
"There are a total of 13 clinical trial sites currently operational for this study. These include University of Texas - MD Anderson Cancer Center in Houston, Memorial Sloan Kettering Cancer Center in New york, and Montefiore Medical Center - Albert Einstein College of Medicine in Bronx."
Answered by AI
Are people still able to sign up for this experiment?
"The study is seeking participants and the information on clinicaltrials.gov indicates that it was first posted on 1/4/2022 and last updated on 10/11/2022."
Answered by AI
How many individuals are participating in this clinical trial?
"In order to properly run this clinical trial, 750 participants who meet the pre-determined inclusion criteria must enroll. There are various hospitals and medical centres across the country that are participating in this trial, such as University of Texas - MD Anderson Cancer Center located in Houston, Texas and Memorial Sloan Kettering Cancer Center situated in New york, New York."
Answered by AI
Who else is applying?
What state do they live in?
Mississippi
Texas
What site did they apply to?
University of Texas - MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
I’m looking for paid study’s. I’ve been having severe back pain, sciatica and leg pain, and neuropathy.
PatientReceived 2+ prior treatments
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