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NCT04251962
Role of Opioids in Epidural Solutions
Phase 4 trial testing Bupivacaine in Postoperative Pain in 135 participants. Completed in 2 March 2022.
2 March 2022
Quick facts
| Lead sponsor | Tel-Aviv Sourasky Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 135 |
| Start date | 1 August 2020 |
| Primary completion | 2 March 2022 |
| Estimated completion | 2 March 2022 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Bupivacaine (BUPIVACAINE) — full drug profile →
- Fentanyl (fentanyl) — full drug profile →
Conditions studied
- Postoperative Pain — all drugs for Postoperative Pain →
Sponsor
Tel-Aviv Sourasky Medical Center
Who can join
Adults 18 to 85, any sex, with Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
It is unclear whether addition of opioids to epidural solutions for postoperative analgesia is beneficial. In this multicenter randomized double-blinded trial, we aim to test the primary hypothesis that epidural solutions containing only bupivacaine are as effective as solutions containing both bupivacaine and fentanyl in promoting analgesia in patients recovering from open abdominal surgery. We also aim to assess the incidence of epidural-induced hypotension, the difference in patient-reported opioid side-effects between the two groups. If we demonstrate no clinically important difference between the two interventions, clinicians will be able to substantially reduce the amount of opioids patients receive during their postoperative recovery, and potentially decrease the associated high incidence of opioid adverse effects in post-surgical patients.
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 NCT04251962
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
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Trials testing the same drug.
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- NCT07430085 — Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA · Phase 4 · not yet recruiting
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Other recruiting trials for Postoperative Pain
Currently open trials in the same condition.
- NCT07452120 — DIPB vs. SIFIB for Postoperative Analgesia After Hip Surgery · NA · recruiting
- NCT07396688 — Comparative Evaluation of the Effects of Calcium Hydroxide and BIO-C Temp Medicaments on Postoperative Pain in Patients · NA · recruiting
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- NCT07396545 — External Oblique Intercostal Block Versus Erector Spinae Plane Block on Postoperative Pain in Laparoscopic Radical Gastr · NA · recruiting
Other Tel-Aviv Sourasky Medical Center trials
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 NCT04251962 (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 Tel-Aviv Sourasky Medical Center
- Last refreshed: 12 April 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/NCT04251962.
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