Last reviewed · How we verify
NCT05201820: COPPER
Cryoanalgesia for Pain Management After Pectus Excavatum Repair
NA trial testing Cryoanalgesia in Pectus Excavatum in 88 participants. Completed in 19 March 2024.
19 March 2024
Quick facts
| Lead sponsor | Istituto Giannina Gaslini |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 88 |
| Start date | 1 February 2022 |
| Primary completion | 19 March 2024 |
| Estimated completion | 19 March 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Cryoanalgesia
Conditions studied
- Pectus Excavatum — all drugs for Pectus Excavatum →
Sponsor
Istituto Giannina Gaslini — full company profile →
Who can join
12 and older, any sex, with Pectus Excavatum. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Cryoanalgesia for pain management after pectus excavatum repair. COPPER study (CryoanalgesiafOr Pain management after Pectus Excavatum Repair): a randomized controlled trial. Determine if, in patients more than 12 years of age having cryoanalgesia for pectus excavatum repair analgesia improves the standard of care (epidural analgesia) in term of pain relief and return to normal life 2 weeks after surgery. Randomized active controlled, parallel group, single-centre, trial (category IIb medical device). 88 patients aged more than 12 years of age scheduled for pectus excavatum repair. After randomization, patients will receive intraoperative cryo-analgesia or standard of care (epidural-analgesia). PedsQLscale (23 items) two weeks after surgery. Patients will be followed for 6 months after surgery to determine time until return to normal life and occurrence of any complication related to the use of cryo-analgesia. Numeric Rating Scale (NRS), CALI9, YAPFAQ will be measured at fixed times to determine pain intensity and limitations due to pain. Risk factors for prolonged pain and time needed until achieving discharge criteria from hospital will be reported.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Comparison of Analgesia Methods Through a Web Platform in Patients Undergoing Thoracic Surgery: Pilot Design, Implementation, and Validation Study.
Trò R, Orecchia A, Disma N, Uva P, et al · · 2024 · cited 1× · PMID 39378419 · DOI 10.2196/56674 -
Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER) in Adolescents: A Randomized Controlled Trial.
Bastianello M, Torre M, Bonfiglio R, Calevo MG, et al · · 2025 · PMID 40035332 · DOI 10.1111/pan.15090
Verify or expand the search:
- PubMed search for NCT05201820
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cryoanalgesia
Trials testing the same drug.
- NCT06661187 — Simple Psychological Interventions and Cryoanalgesia · NA · completed
- NCT06284109 — Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain · NA · withdrawn
- NCT05993273 — Pain Control After VATS Anatomical Pulmonary Resections · NA · completed
- NCT05251688 — Cryoanalgesia for Arterial Puncture Pain · NA · completed
- NCT02922153 — The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST) · NA · completed
Other recruiting trials for Pectus Excavatum
Currently open trials in the same condition.
- NCT06436755 — Serratus Anterior Plane Block and Transthoracic Plane Block in Pectus Surgery · recruiting
- NCT06918392 — Field-test and Psychometric Validation of the Pectus Excavatum Evaluation Questionnaire in the Dutch Pectus Excavatum Po · recruiting
Other Istituto Giannina Gaslini trials
Trials by the same sponsor.
- NCT07377630 — Intrathecal MoRphine Versus Transabdominal Plane Block (TAP) Block for AnalGesic Management in Elective Caesarean Sectio · Phase 4 · not yet recruiting
- NCT06618937 — Toward Personalized Medicine to Guide Drug Withdrawal in Children with Juvenile Idiopathic Arthritis in Clinical Remissi · Phase 4 · not yet recruiting
- NCT06331611 — MONITORING NEUROMUSCULAR BLOCK IN PAEDIATRIC ANAESTHESIA · NA · unknown
- NCT05075837 — Adoptive T-cell Therapy for Resistant Viral Infections After Allogeneic HSCT · Phase 1 · unknown
- NCT06150404 — A Randomized Controlled Trial to Evaluate the Effect of White Noises and Parental Voices As Protectors Against Noise Dam · NA · terminated
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 NCT05201820 (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 Istituto Giannina Gaslini
- Last refreshed: 20 March 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/NCT05201820.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing