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NCT05727098
Dexmedetomedine and Ketamine in Erector Spinae Block for Postoperative Analgesia Following Mastectomy.
Phase 2, PHASE3 trial testing Bupivacaine Hydrochloride in Breast Cancer in 75 participants. Completed in 30 April 2023.
30 April 2023
Quick facts
| Lead sponsor | National Cancer Institute, Egypt |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 1 January 2023 |
| Primary completion | 30 April 2023 |
| Estimated completion | 30 April 2023 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Bupivacaine Hydrochloride (Bupivacaine Hydrochloride) — full drug profile →
- Bupivacaine Hydrochloride and dexmedetomedine
- Bupivacaine Hydrochloride and ketamine
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
National Cancer Institute, Egypt
Who can join
Adults 18 to 65, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Persistent pain after breast cancer surgery is frequently observed in more than 60% of patients.The suboptimal management of perioperative pain can lead to the occurrence of persistent breast cancer pain syndrome and phantom breast pain. Dexmedetomidine, a novel α2-agonist with an eight-fold affinity for α2-adrenergic receptors (sedate and analgesic effects) as clonidine, while exerts much less α1-effects., has been found to significantly increase the duration of peripheral nerve blocks, with minimal systemic side effects. Ketamine is a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptors. It is used for sedation, premedication, induction, and maintenance of general anesthesia. Central, regional, and local anesthetic and analgesic properties have been reported for ketamine. Both can be used through Erector spinae plane block for postoperative pain control.
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 NCT05727098
- 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 Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other National Cancer Institute, Egypt trials
Trials by the same sponsor.
- NCT07424638 — Interscalene Block Versus Anterior Suprascapular Block for Post-Thoracotomy Shoulder Pain · NA · recruiting
- NCT07367568 — Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy · NA · recruiting
- NCT07367581 — Costotransverse Foramen Block Versus Thoracic Paravertebral Block in Thoracotomy for Lung Cancer · NA · recruiting
- NCT07337330 — Ultrasound Guided External Oblique Intercostal Plane Block Versus Erector Spinae Block for Post Hepatectomy Pain · NA · not yet recruiting
- NCT07390448 — Rhomboid Intercostal Sub-serratus Plane Blocks and Erector Spinae Plane Block in Mastectomy Surgeries · NA · recruiting
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 NCT05727098 (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 National Cancer Institute, Egypt
- Last refreshed: 8 June 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/NCT05727098.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing