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Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain

Study acronym: KALPAS
StatusActive, Not Recruiting
PhasePhase 3
Started2022-01-04
View on ClinicalTrials.gov ↗

Amendment history

2026-06-04
2 amendments v10-v11
2 re-verifications since 2026-05-04, no change to tracked fields
2025-06-24
Study Status v9
Primary completion dateestimated 2025-06-01→confirmed 2025-05-28
Completion date2026-03-01→2026-08-31
2025-04-15
Study Status, Document Section v8
Re-verified, no change to tracked fields
2025-04-10
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-10-31→2025-06-01
Completion date2025-10-31→2026-03-01
Enrollment targetestimated 750→confirmed 765
Study sitesdetails revised at 14 of 14 sites
2024-06-25
Study Status v6
Primary completion date2024-10→2024-10-31
Completion date2025-10→2025-10-31
Show 5 earlier versions
2023-08-07
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v5
Study sites13→14
Eligibility criteria+12 characters
[...] -aminopyridine use Currently Pregnant Body mass index (BMI) equal to or greater than 3541 Non-English or non-Spanish speaker Currently participating [...]
Secondary endpoints4 entries, revised
AnxietyPROMIS Depression and depressed mood: Hospital Anxiety andShort DepressionForm Scale (HADS) ScoreScores
Study description+1,181 characters
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to study the effectiveness of ketamine in reducing PMPS. In a 3-arm, parallel-group study, approximately 750 adult women undergoing mastectomy or prophylactic mastectomy for oncologic reasons will be randomized to one [...]
2022-10-11
Study Status, Study Design v4
Re-verified, no change to tracked fields
2022-07-29
Study Status, Study Description, Conditions, Arms and Interventions, Contacts/Locations v3
Study sites1→13
2022-03-21
Study Status, Arms and Interventions, Outcome Measures v2
Secondary endpointsdetails revised at 3 of 4 entries
2022-03-02
Not Yet Recruiting→Recruiting Study Status, Study Description, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-10-01→confirmed 2022-01-04
Study sites0→1
2021-08-31
Original filing
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 Details
NCT Number NCT05037123
Lead Sponsor NYU Langone Health
Collaborators: National Cancer Institute (NCI)
Conditions Chronic Postsurgical Pain
Enrollment 765 participants
Start Date 2022-01-04
Primary Completion 2025-05-28 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-08