Comparison Between Levobupivacaine and Levobupivacaine With Dexmedetomidine in Ultrasound Guided Pectoral Nerve Block

• Status: Terminated
• Trial end date: 2018-01-12
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Antwerp
• Treatments: Bupivacaine; Dexmedetomidine; Levobupivacaine

Criteria

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