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NCT05352282
Comparative Study Between the Efficacy of The Serratus Anterior Plane Block and Lumbar Intrathecal Fentanyl Injection for Postoperative Analgesia After Modified Radical Mastectomy
NA trial testing Serratus Anterior Plane Block in Patients Undergoing Modified Radical Mastectomy in 50 participants. Completed in 1 February 2023.
1 February 2023
Quick facts
| Lead sponsor | Sohag University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 50 |
| Start date | 1 April 2022 |
| Primary completion | 1 February 2023 |
| Estimated completion | 1 February 2023 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Serratus Anterior Plane Block
- Lumbar Intrathecal Fentanyl Injection
Conditions studied
- Patients Undergoing Modified Radical Mastectomy — all drugs for Patients Undergoing Modified Radical Mastectomy →
Sponsor
Sohag University
Who can join
Adults 18 to 60, any sex, with Patients Undergoing Modified Radical Mastectomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Modified radical mastectomy (MRM) is one of the most common surgeries performed, and one that may be associated with significant acute postoperative pain in breast surgery. Acute postoperative pain is an independent risk factor in the development of chronic post-mastectomy pain . Various regional anesthetic procedures have been tried to provide better acute pain control and, consequently, less chronic pain. They can reduce perioperative opiates requirement and thereby decreasing their possible side effects. These regional procedures include local wound infiltration, lumbar intrathecal fentanyl injection, thoracic epidural, thoracic paravertebral block (PVB), and ultrasound (US)-guided interfascial plane blocks. Currently, Ultrasound (US)-guided interfascial plane blocks have been recommended as safe, easy, and reliable alternatives to the use of thoracic epidural and paravertebral blocks in providing analgesia for patients about to undergo breast surgery. Serratus anterior plane block (SAPB) is one of the Ultrasound (US)-guided interfascial plane blocks, it blocks the intercostal nerves II-VI by injection above or below the serratus muscle in the mid-axillary line and spares the pectoral nerves. We assumed that SAPB could safely provide a better analgesic profile with an opioid-sparing effect than Intrathecal fentanyl. We will perform this study to evaluate this assumption.
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 NCT05352282
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Serratus Anterior Plane Block
Trials testing the same drug.
- NCT07302399 — Comparison of the Postoperative Analgesic Efficacy of SAP and SPSIP Blocks in Patients Undergoing Mammoplasty · NA · not yet recruiting
- NCT06778642 — Postoperative Analgesic Comparison of SPSI Block and SAP Block in Video-Assisted Thoracoscopic Surgery (VATS) · NA · not yet recruiting
- NCT06862752 — Erector Spinae Plane Block Versus Serratus Anterior Plane Block · NA · completed
- NCT06948383 — SPSIPB vs. SAPB in Breast Surgery · NA · active not recruiting
- NCT06567275 — Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block in Coarctectomy · NA · completed
Other Sohag University trials
Trials by the same sponsor.
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- NCT07515365 — Colitis Patterns in Patients With Lower GI Symptoms · not yet recruiting
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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 NCT05352282 (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 Sohag University
- Last refreshed: 8 February 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/NCT05352282.
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