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NCT05037123: KALPAS
Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
Phase 3 trial testing Continuous ketamine infusion in Chronic Postsurgical Pain in 765 participants. Participants enrolled and being followed up; not accepting new ones.
28 May 2025
Quick facts
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 765 |
| Start date | 4 January 2022 |
| Primary completion | 28 May 2025 |
| Estimated completion | 31 August 2026 |
| Sites | 14 locations across United States |
Drugs / interventions tested
- Continuous ketamine infusion — full drug profile →
- Ketamine + Saline
- Placebo
Conditions studied
- Chronic Postsurgical Pain — all drugs for Chronic Postsurgical Pain →
Sponsor
NYU Langone Health — full company profile →
Who can join
18 and older, female only, with Chronic Postsurgical Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pain associated with breast cancer: etiologies and therapies.
Doan LV, Yoon J, Chun J, Perez R, et al · · 2023 · cited 15× · PMID 38148788 · DOI 10.3389/fpain.2023.1182488 -
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.
Wang J, Doan LV, Axelrod D, Rotrosen J, et al · · 2024 · cited 2× · PMID 38243266 · DOI 10.1186/s13063-023-07884-y -
The Use of Electronic Consent (eConsent) Within the Ketamine for Long-Lasting Pain Relief After Surgery (KALPAS) Multicenter Trial.
Doan LV, Burr J, Perez R, Martinez H, et al · · 2025 · PMID 39931425 · DOI 10.2147/jpr.s488917
Verify or expand the search:
- PubMed search for NCT05037123
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Postsurgical Pain
Currently open trials in the same condition.
- NCT06946290 — Intertransverse Process Block to Improve Quality of Recovery and Pain Management in Adult Cardiac Surgical Patients · NA · recruiting
Other NYU Langone Health trials
Trials by the same sponsor.
- NCT07214519 — Permanent Supportive Housing Overdose Prevention-2 Study · NA · not yet recruiting
- NCT05558267 — Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease · NA · not yet recruiting
- NCT06637852 — Sexual and Urinary Function Improvement for Cancer Survivors · NA · not yet recruiting
- NCT06236087 — Overdose Prevention Centers and Behavioral Health · not yet recruiting
- NCT06462027 — Packed Red Blood Cell Transfusion During Cardiac Arrest · Phase 1 · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05037123 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
- Last refreshed: 25 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05037123.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing