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NCT04778267
Effectiveness of Combined Erector Spinae and Pecto-intercostal Fascial Plane Blocks Versus Thoracic Paravertebral Block in Perioperative Pain in Modified Radical Mastectomy
Phase 4 trial testing Bupivacaine Hydrochloride in Modified Radical Mastectomy in 30 participants. Completed in 10 March 2023.
9 March 2023
Quick facts
| Lead sponsor | Kasr El Aini Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 12 March 2021 |
| Primary completion | 9 March 2023 |
| Estimated completion | 10 March 2023 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Bupivacaine Hydrochloride (Bupivacaine Hydrochloride) — full drug profile →
- Dexamethasone phosphate
Conditions studied
- Modified Radical Mastectomy — all drugs for Modified Radical Mastectomy →
Sponsor
Kasr El Aini Hospital
Who can join
Adults 18 to 60, female only, with Modified Radical Mastectomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Erector spinae plane block (ESPB) is a new evolving fascial pain block in the era of regional anaesthesia. ESPB was applied in varieties of surgeries and provided an eminent role in trauma patient especially those with fracture ribs. ESPB exhibits simple, safe and easy technique with minimal or no sympathetic blockade effects, thus gaining popularity in wide range of surgeries. The optimum effective dose of local anaesthetic, the effective volume of drug used for desired dermatomes. Comparison with different regional blocks is preferable to know the optimum analgesic technique for those population of patients (4). Many studies have already compared solo ESPB with thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), serratus anterior plane block (SAPB) and pectoral nerves block. Only few case reports described the combination effect of rhomboid intercostal, transversus thoracic muscle and parasternal plane blocks to ESPB in modified radical mastectomy.
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 NCT04778267
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bupivacaine Hydrochloride
Trials testing the same drug.
- NCT07512635 — Effect of Intercostal Nerve Block With Liposomal Bupivacaine on Quality of Recovery in VATS Partial Pneumonectomy · Phase 4 · not yet recruiting
- NCT06704698 — Postoperative Analgesia Between Paravertebral Block and Epidural Block in Esophageal Surgery · NA · recruiting
- NCT06575699 — Rectus Sheath Block for Analgesia After Gynecological Laparotomy · Phase 4 · completed
- NCT06577233 — Superior Hypogastric Nerve Plexus Block With Bupivacaine After Robotic Resection of Endometriosis · Phase 4 · recruiting
- NCT06569953 — Efficacy and Safety of Liposomal Bupivacaine Injection for Paravertebral Nerve Block in the Treatment of Acute and Chron · Phase 4 · recruiting
Other recruiting trials for Modified Radical Mastectomy
Currently open trials in the same condition.
- NCT07367568 — Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy · NA · recruiting
- NCT06947330 — Comparison Between Erector Spinae Plane Block Versus Serratus Anterior Plane Block Regarding Analgesia Post Modified Rad · Phase 3 · recruiting
- NCT06815887 — Adding Magnesium Sulfate to Local Anesthetic in Combined Pectoral Nerve and Stellate Ganglion Block for Postoperative Pa · NA · recruiting
Other Kasr El Aini Hospital trials
Trials by the same sponsor.
- NCT07438652 — Effect of Mediterranean vs Paleolithic Diet on RA Activity, Sarcopenia and QOL: 12-Week RCT · NA · recruiting
- NCT07488039 — Labroplasty in Cases of Anterior Shoulder Instability With Subcritical Glenoid Bone Loss · NA · recruiting
- NCT07274280 — Comparative Evaluation of Ambu AuraGain, LarySeal Pro and I-gel in Pediatric Airway Management for Day-Case Surgery Unde · NA · not yet recruiting
- NCT07348146 — Hand-Sewn vs. Stapled Anastomosis in SADI-S: Early Postoperative Complications. · NA · enrolling by invitation
- NCT07077265 — Comparing Two Different Norepinephrine Infusion Rates for Prophylaxis Against Spinal-induced Hypotension in Elderly · NA · completed
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 NCT04778267 (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 Kasr El Aini Hospital
- Last refreshed: 13 March 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/NCT04778267.
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