Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
KALPAS
1 other identifier
interventional
765
1 country
14
Brief Summary
The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine in reducing chronic post-mastectomy pain. Participants randomized to the first arm will receive a 0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during surgery (up to a maximum of 6 hours) and continued for 2 hours postoperatively. Participants in the second arm will receive a single dose of 0.6 mg/kg of ketamine in the post-anesthesia care unit, and the final group will serve as the control group and receive saline (no ketamine).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2022
Longer than P75 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2021
CompletedFirst Posted
Study publicly available on registry
September 8, 2021
CompletedStudy Start
First participant enrolled
January 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedMay 6, 2026
May 1, 2026
3.4 years
August 31, 2021
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BPI pain severity subscale score
The Brief Pain Inventory short form (BPI) pain severity subscale assesses pain at its worst, least, average, and current in the past 24 hours. The score ranges from 0 to 10 for each item. The average of the four items will be used. The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
3 months
Secondary Outcomes (4)
BPI pain severity and pain interference subscales score
Baseline, 1 and 7 days and 1, 3*, 6, and 12 months after surgery
Incidence of PMS: BPI average pain score
Baseline, 3, 6, and 12 months after surgery
Pain in the surgical site (chest wall, axilla, and/or arm): BCPQ Score
7 days and 1, 3, 6, and 12 months after surgery
PROMIS Depression and Anxiety Short Form Scores
Baseline, 7 days and 1, 3, 6, and 12 months after surgery
Study Arms (3)
Arm 1 Continuous ketamine infusion group
ACTIVE COMPARATORContinuous 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
Arm 2 Ketamine + Saline group
ACTIVE COMPARATORSaline 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
Arm 3 Placebo group
PLACEBO COMPARATORPlacebo, Saline dose and infusion intraoperatively, then saline IV dose in post-anesthesia care unit plus 2 hours of saline administration after surgery
Interventions
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
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
Placebo, Saline dose and infusion intraoperatively, then saline IV dose in post-anesthesia care unit plus 2 hours of saline administration after surgery
Eligibility Criteria
You may qualify if:
- Woman 18 years of age or older
- Undergoing elective breast surgery for oncologic indication as follows: unilateral or bilateral mastectomy, prophylacticmastectomy, +/- lymph node dissection, +/- immediate or delayed reconstruction.
- No distant metastases
You may not qualify if:
- History of cognitive impairment or clinical signs of altered mental status (AMS) that may interfere with adherence to study procedures and/or participant safety. Clinical signs of AMS may include but are not limited to: confusion, amnesia, disorientation, fluctuating levels of alertness, etc.
- Past ketamine or phencyclidine misuse or abuse
- Schizophrenia or history of psychosis
- History of post-traumatic stress disorder
- Known sensitivity or allergy to ketamine
- Liver or renal insufficiency
- History of uncontrolled hypertension, chest pain, cardiac arrhythmia, stroke, head trauma, intracranial mass or hemorrhage, glaucoma, porphyria, uncontrolled thyroid disease, or other contraindication to ketamine
- Lamotrigine, alfentanil, physostigmine, or 4-aminopyridine use
- Currently Pregnant
- Body mass index (BMI) equal to or greater than 41
- Non-English or non-Spanish speaker
- Currently participating in another pain interventional trial
- Unwilling to comply with all study procedures and be available for the duration of the study
- Patient is American Society of Anesthesiologists (ASA) physical status 4, 5, or 6
- Patient has started or undergone hormone therapy for gender transition into male.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Cancer Institute (NCI)collaborator
Study Sites (14)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Arkansas
Little Rock, Arkansas, 72205, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Brigham and Women's Hospital - Harvard University
Chestnut Hill, Massachusetts, 02467, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University at St. Louis Medical Center
St Louis, Missouri, 63110, United States
NYU Langone Health (Tisch Hospital, Kimmel Pavilion)
New York, New York, 10016, United States
New York Presbyterian Columbia University Irving Medical Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Montefiore Medical Center - Albert Einstein College of Medicine
The Bronx, New York, 10467, United States
University of Pittsburgh - Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States
University of Texas - Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Publications (1)
Wang J, Doan LV, Axelrod D, Rotrosen J, Wang B, Park HG, Edwards RR, Curatolo M, Jackman C, Perez R; NCATS Trial Innovation Network. Optimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication: study protocol for the KALPAS multicenter randomized controlled trial. Trials. 2024 Jan 19;25(1):67. doi: 10.1186/s13063-023-07884-y.
PMID: 38243266DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jing Wang, MD, PhD
NYU Langone Health
- PRINCIPAL INVESTIGATOR
Lisa Doan, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Participants, study members, and treating clinicians will be blinded to intervention.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2021
First Posted
September 8, 2021
Study Start
January 4, 2022
Primary Completion
May 28, 2025
Study Completion (Estimated)
August 31, 2026
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- Requests should be directed to Jing.Wang2@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.