Clinical trial · Interventional
Dexmedetomidine Versus Dexamethasone as Adjuncts in Erector Spinae Plane Block in Modified Radical Mastectomy
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuncts to Levobupivacaine in Ultrasound Guided Erector Spinae Plane Block for Patients Undergoing Modified Radical Mastectomy, Randomized Double-Blinded Comparative Study.
NCT05447949CI-TRIAL-00059540completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to evaluate the analgesic efficacy and safety of adding dexmedetomidine versus dexamethasone to levobupivacaine in ultrasound guided ESPB for patients undergoing modified radical mastectomy
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Post Operative Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuncts to levobupivacaine in Erector Spinae Plane Block | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group 1 (ESPB + Dexmedetomidine)
- description
- Patients received Ultrasound guided ESPB with addition of dexmedetomidine 1 Mcg/kg to 30 ml levobupivacaine 0.25%, N=30 (16)
- interventionNames
- Procedure: Adjuncts to levobupivacaine in Erector Spinae Plane Block
- type
- EXPERIMENTAL
- label
- Group 2 (ESPB+ dexamethasone)
- description
- Patients received Ultrasound guided ESPB with addition of dexamethasone 10 mg to 30 ml levobupivacaine 0.25%, N=30 (16)
- interventionNames
- Procedure: Adjuncts to levobupivacaine in Erector Spinae Plane Block
- type
- ACTIVE_COMPARATOR
- label
- Group 3 (ESPB)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Type of surgery; Modified Radical Mastectomy (MRM) * Physical status ASA II, III. * Age ≥ 18 and ≤ 65 Years. * Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2. Exclusion Criteria: * Patient's refusal * Age \<18 years or \>65 years * BMI \<20 kg/m2 and \>35 kg/m2 * Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids). * History of psychological disorders and/or chronic pain. * Contraindication to regional anaesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy. * Severe respiratory or cardiac disorders. * Advanced liver or kidney disease. Pregnancy. * Physical status ASA IV.
References
Publications (0)
Data not yet available
No reference posted for this study.