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NCT06044103
Patient-controlled Sedation During Repair of Obstetric Perineal Lacerations
Phase 4 trial testing PDB + PCS in Pain in 80 participants. Status unknown.
30 May 2024
Quick facts
| Lead sponsor | Marie Blomberg |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 80 |
| Start date | 20 September 2023 |
| Primary completion | 30 May 2024 |
| Estimated completion | 30 October 2024 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- PDB + PCS — full drug profile →
Conditions studied
- Pain — all drugs for Pain →
- Patient Satisfaction — all drugs for Patient Satisfaction →
Sponsor
Marie Blomberg — full company profile →
Who can join
18 and older, female only, with Pain or Patient Satisfaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The PROP(ofol)-study (EU CT number: 2022-502292-39-00, protocol number: ) is a clinical trial phase IV single centre prospective randomized controlled trial with parallel groups. A total of 80 women who undergoes examination and repair of obstetric perineal lacerations (grade I and II) are randomized into two arms (1:1); analgesia with pudendal nerve block (PNB) with ropivacaine (clinical routine, control group), or analgesia with PNB in combination with patient-controlled sedation with propofol (PCS, PCS group). The hypothesis is that PNB in combination with PCS improves patient experienced pain/discomfort during the examination and repair of the perineal laceration. The primary endpoint is patient experienced pain/discomfort. Secondary endpoints are time of repairing the perineal laceration, ability to have skin-to-skin contact with the baby during perineal repair, time until micturition after the perineal repair, procedure feasibility, amount of drugs used during perineal repair, and use of pain relief 24h postpartum. The study is planned to start during the second half of 2023 and end during the first half of 2024.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06044103
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT06044103 (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 Marie Blomberg
- Last refreshed: 21 September 2023
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/NCT06044103.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing