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NCT05579223: IMPAS
Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery
Phase 2 trial testing Intrathecal Hydromorphone Mono Injection in Acute Pain in 150 participants. Completed in 27 January 2024.
24 January 2024
Quick facts
| Lead sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 17 October 2022 |
| Primary completion | 24 January 2024 |
| Estimated completion | 27 January 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Intrathecal Hydromorphone Mono Injection — full drug profile →
- Intrathecal Placebo Mono Injection — full drug profile →
Conditions studied
- Acute Pain — all drugs for Acute Pain →
- Post Operative Pain — all drugs for Post Operative Pain →
- Anorectal Disorder — all drugs for Anorectal Disorder →
- Analgesia — all drugs for Analgesia →
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Who can join
Adults 18 to 80, any sex, with Acute Pain or Post Operative Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Anorectal problems, such as hemorrhoids, fistula, fissures, Etc., often require surgical treatment. Patients often have postoperative pain after these surgeries, which increases discomfort and hospital length of stay. The efficacy of oral non-opioids in the treatment of such pain is poor. Hydromorphone is an opioid analgesic commonly used orally or intravenously for postoperative pain management. We designed this trial to investigate the efficacy and safety of intrathecal (delivery directly to the spinal cord during spinal anesthesia) single dose hydromorphone versus intrathecal placebo in treating postoperative pain among human subjects after anorectal surgery, but also the recovery of postoperative motor capacity in these human subjects.
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 NCT05579223
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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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 NCT05579223 (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 Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Last refreshed: 30 January 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/NCT05579223.
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