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NCT03421522: INSPIRE
Intercostobrachial Nerve Sparing to Reduce Post-Surgical Pain
NA trial testing ICBN preservation surgery in Post-surgical Pain in 50 participants. Status unknown.
1 December 2020
Quick facts
| Lead sponsor | McMaster University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 50 |
| Start date | 15 October 2019 |
| Primary completion | 1 December 2020 |
| Estimated completion | 1 December 2020 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- ICBN preservation surgery
Conditions studied
- Post-surgical Pain — all drugs for Post-surgical Pain →
- Pain, Chronic — all drugs for Pain, Chronic →
- Intercostal Pain — all drugs for Intercostal Pain →
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
McMaster University
Who can join
18 and older, female only, with Post-surgical Pain or Pain, Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Sacrifice of the intercostobrachial nerve (ICBN) during surgery is associated with development of persistent post-surgical pain (PPSP), which affects up to 60% of breast cancer surgery patients. A large, definitive trial is needed to establish whether nerve preservation techniques are effective in reducing post-surgical pain after breast cancer surgery. If the effect of ICBN preservation is consistent with observational studies, the absolute reduction of rates of persistent pain would be considerable.The primary objective is to determine the effect of ICBN preservation, versus usual care, on the prevalence and intensity of PPSP at one year after breast cancer surgery involving axillary lymph node dissection (ALND). Within the larger INSPIRE pilot, we will also be conducting a biomarker sub-study. The objectives of the biomarker sub-study are: 1) to determine the association between pro-inflammatory cytokine levels and the presence and intensity of persistent pain at 3 weeks, and 3 months post-surgery, and) 2) to determine the effect of study intervention on the change in cytokine levels (pre-operative to post-operative) in participants who consent to participate in the sub-study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03421522
- Europe PMC full search
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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 NCT03421522 (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 McMaster University
- Last refreshed: 26 June 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/NCT03421522.
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