Status:
TERMINATED
Comparison Between Levobupivacaine and Levobupivacaine With Dexmedetomidine in Ultrasound Guided Pectoral Nerve Block
Lead Sponsor:
University Hospital, Antwerp
Conditions:
Breast Cancer
Mastectomy, Modified Radical
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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 dexmedetom...
Detailed Description
Women (18+, American Society of Anesthesiologists 1,2,3) undergoing a mastectomy with axillar procedure will be randomised and receive a ultrasound guided modified pectoral nerve block, if participant...
Eligibility Criteria
Inclusion
- women,
- 18years and older
- American Society of Anesthesiologists 1, 2,3,
- planned for radical mastectomy.
Exclusion
- 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
Key Trial Info
Start Date :
May 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 12 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03456661
Start Date
May 19 2014
End Date
January 12 2018
Last Update
September 20 2019
Active Locations (1)
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1
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650