Last reviewed · How we verify
NCT03912948: DCPO Sein
Chronic Pain and Minor Breast Cancer Surgery
trial in Surgery in 205 participants. Completed in 31 December 2019.
30 September 2019
Quick facts
| Lead sponsor | Institut Claudius Regaud |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 205 |
| Start date | 1 April 2019 |
| Primary completion | 30 September 2019 |
| Estimated completion | 31 December 2019 |
| Sites | 1 location across France |
Conditions studied
- Surgery — all drugs for Surgery →
- Breast Cancer — all drugs for Breast Cancer →
- Pain, Postoperative — all drugs for Pain, Postoperative →
- Pain, Chronic — all drugs for Pain, Chronic →
Sponsor
Institut Claudius Regaud — full company profile →
Who can join
18 and older, female only, with Surgery or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Breast cancer is the most frequent in women. Early diagnosis and recent treatments have improved overall mortality. However, chronic pain (pain lasting more than 3 months after surgery) remains a public health problem with impact on quality of life for these patients. The incidence of pain has been reported up to 25 to 60% of patients in the literature, even many years after a radical mastectomy. The neuropathic component of the pain is usually underestimated. In a prospective cohort study we have demonstrated that 43% of patient needed on average 5mg of morphine intravenously in the recovery room after a conservative breast cancer surgery, despite a multimodal regimen of analgesic drugs. In the same study, 40% of patients reported persistent pain 3 months after the surgery. To improve the analgesia in such a population, we decided to introduce regional analgesia technique (serratus block) systematically. This became our gold standard in our daily practice. We would like to assess the efficacy of such regional analgesia techniques on opioids consumption in the recovery room and the incidence of pain 3 months after conservative breast cancer surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03912948
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Institut Claudius Regaud 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 NCT03912948 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut Claudius Regaud
- Last refreshed: 4 March 2020
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/NCT03912948.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing