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

NCT03456661 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-09-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Levobupivacaine

Infiltration with 0.25% 29,5ml + 0,5ml physiologic serum (total volume 30ml), US guided, using pectoralis block technique.

DRUG

Levobupivacaine + Dexmedetomidine

Infiltration with chirocaine 0.25% 29,5ml + 0,5ml dexmedetomidine (50µg) (total volume 30ml), US guided, using pectoralis block technique.

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Hilde Coppejans, MD · University Hospital, Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-19
Primary Completion
2018-01-12
Completion
2018-01-12

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03456661 on ClinicalTrials.gov