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NCT03090776
Prevention of Post Mastectomy With Intraoperative Ketamine
EARLY_PHASE1 trial testing Ketamine in Pain, Postoperative in 200 participants. Status unknown.
16 October 2025
Quick facts
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 200 |
| Start date | 1 July 2017 |
| Primary completion | 16 October 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ketamine (ketamine) — full drug profile →
- Placebo saline
Conditions studied
- Pain, Postoperative — all drugs for Pain, Postoperative →
- Post-Mastectomy Chronic Pain Syndrome — all drugs for Post-Mastectomy Chronic Pain Syndrome →
Sponsor
Brigham and Women's Hospital
Who can join
Adults 18 to 85, female only, with Pain, Postoperative or Post-Mastectomy Chronic Pain Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Aim 1: To determine the effectiveness of perioperatively administered ketamine to decrease acute and persistent postmastectomy pain (PPMP). Hypothesis 1.1: Patients undergoing partial or total mastectomy treated with a bolus and perioperative infusion of the NMDA-receptor antagonist ketamine will have decreased postoperative pain and opioid utilization compared to those receiving saline control. Hypothesis 1.2: Patients undergoing partial or total mastectomy treated with a bolus and perioperative infusion of the NMDA-receptor antagonist ketamine will have decreased persistent postoperative pain measured at one year after surgery. Aim 2: To determine whether there is increased power to detect therapeutic effectiveness in an interventional preventive trial, by enrichment with patients at high risk of PPMP. Hypothesis 2.1: Ketamine will have a greater analgesic and opioid sparing effect on pain scores in high-risk patients than non-high risk patients, compared to placebo. Hypothesis 2.2: Ketamine will have a greater preventive effect on pain burden scores at one year after surgery in high-risk patients than non-high risk patients, compared to placebo.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Randomized Controlled Trial of Intraoperative Ketamine for Acute Postsurgical Pain after Breast Cancer Surgery: The Moderating Effect of Baseline Temporal Summation of Pain.
Wilson JM, Gokul S, Franqueiro AR, Rosado E, et al · · 2025 · cited 6× · PMID 40663518 · DOI 10.1097/aln.0000000000005649
Verify or expand the search:
- PubMed search for NCT03090776
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Pain, Postoperative
Currently open trials in the same condition.
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Other Brigham and Women's Hospital trials
Trials by the same sponsor.
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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 NCT03090776 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 Brigham and Women's Hospital
- Last refreshed: 3 May 2024
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/NCT03090776.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing