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NCT05446311
Naldebain® Extended-release Injection After Cesarean Section in Pain Management
trial testing Dinalbuphine sebacate in Post Operative Pain in 20 participants. Status unknown.
20 December 2022
Quick facts
| Lead sponsor | Tri-Service General Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 15 July 2022 |
| Primary completion | 20 December 2022 |
| Estimated completion | 31 December 2022 |
Drugs / interventions tested
- Dinalbuphine sebacate — full drug profile →
Conditions studied
- Post Operative Pain — all drugs for Post Operative Pain →
- Caesarean Section — all drugs for Caesarean Section →
- Analgesia — all drugs for Analgesia →
Sponsor
Tri-Service General Hospital
Who can join
Adults 20 to 45, female only, with Post Operative Pain or Caesarean Section. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Cesarean section is one of the surgeries most commonly leading to postoperative severe acute pain. It was reported that the mean worst pain intensity reached to 6.14 one day after cesarean section in Germany. Inadequate pain management may result in the cardiorespiratory complications, late recovery, and postoperative chronic pain. According to a series of pain management article published in the Lancent in 2019, the incidence of post-cesarean section chronic pain was 55%, including 12% of severe chronic pain. Extended-release dinalbuphine sebacate, a prodrug of nalbuphine, is a novel analgesic developed in Taiwan and the indication is moderate to severe postoperative pain. After intramuscular injected, dinalbuphine sebacate will be released to blood stream and immediately hydrolyzed. In Taiwan, dinalbuphine sebacate has been used for alleviating pain after several types of surgeries, such as colorectal surgery, orthopaedics, gynecology and obstetrics. However, few post-marketing studies investigated the efficacy and safety of dinalbuphine sebacate.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05446311
- 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 NCT05446311 (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 Tri-Service General Hospital
- Last refreshed: 6 July 2022
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/NCT05446311.
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