Clinical trial · Interventional
Comparison Between Levobupivacaine and Levobupivacaine With Dexmedetomidine in Ultrasound Guided Pectoral Nerve Block
Comparison Between Levobupivacaine 0.25% and Levobupivacaine With Dexmedetomidine in Ultrasound Guided Modified Pectoral Nerve Block, a Double Blind Randomised Controlled Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The surgical approach has changed.
Summary
Brief summary (as posted)
A double blind prospective randomized controlled trial in which the effect of single shot levobupivacaine 0,25% will be compared with the effect of levobupivacaine 0.25% in association with dexmedetomidine when performing an ultrasound guided modified pectoral nerve block , in patients undergoing a mastectomy with axillar procedure. The difference in effect will be evaluated by monitoring the postoperative morphine consumption in both groups . The hypothesis is that there is a significant decrease in morphine consumption during the first 24h postoperatively due to association of dexmedetomidine to the local anesthetic compared to the local anesthetic alone when performing a ultrasound guided modified pectoral nerve block. The morphine consumption will be the primary outcome parameter.
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 |
| Mastectomy, Modified Radical | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Levobupivacaine | Drug | — | UNRESOLVED |
| Levobupivacaine + Dexmedetomidine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Levobupivacaine
- description
- Study Group 1 (Group L): patients undergoing an ultrasound guided modified pectoral nerve block (technique described by Blanco et al\[1\]) with levobupivacaine 0.25% 29,5ml + 0,5ml physiologic serum (total volume 30ml) (10ml between major and minor pectoral muscle and 20ml between minor pectoral muscle and anterior serratus muscle at the level of the third or fourth rib).
- interventionNames
- Drug: Levobupivacaine
- type
- ACTIVE_COMPARATOR
- label
- Levobupivacaine + Dexmedetomidine
- description
- Study Group 2 (Group LD): patients undergoing an ultrasound guided modified pectoral nerve block (a technique described by Blanco et al\[1\]) with levobupivacaine 0.25% 29,5ml + Dexmedetomidine 50µg (0,5ml)with a total volume of 30ml. (10ml between major and minor pectoral muscle and 20ml between minor pectoral muscle and anterior serratus muscle at the level of the third or fourth rib).
- interventionNames
- Drug: Levobupivacaine + Dexmedetomidine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * women, * 18years and older * American Society of Anesthesiologists 1, 2,3, * planned for radical mastectomy. Exclusion Criteria: * Neurological problems (central and peripheral) * Bilateral mastectomy * Body Mass Index \> 33, * Absolute contra-indication for ketorolac. * Allergy/over-sensitiveness to levobupivacaine or local anesthetics of the same class * Allergy/over-sensitiveness to dexmedetomidine or other alpha2 agonists (clonidine) * Anatomic variations of the breast, pectoral region or axilla, noticed at clinical examination, including a pacemaker, Implantable Cardioverter Defibrillator, Port-a-Cath or other implantable device on the side that needs surgery. * Participation in an other clinical trial within a period of four weeks before the beginning of this trial. * Coagulopathy * Infection or abcess in the region where the Block will be placed. * Pregnancy
References
Publications (0)
Data not yet available