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

NCT ID: NCT03456661

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-19
• Study Completion Date: 2018-01-12

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 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.

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 participants meet in- and exclusion criteria and provide written informed consent.

Using a two needle approach, ten milliliters of local anesthetic is injected under ultrasound guidance between the major and minor pectoral muscle and twenty milliliters between the minor pectoral and the serratus anterior muscle, on the side to be operated.

Participants receive intravenous Patient Controlled Analgesia with morphine and dehydrobenzperidol (1mg/ml morphine, 50µg dehydrobenzperidol/ml).

Furthermore every participant in the trial will receive ketorolac 0.5mg/kg three times a day and paracetamol four times 1g per day.

When the analgesia using the intravenous Patient Controlled Analgesia regime isn't sufficient, the anesthesiologist will titrate with morphine until pain free using a protocol (a bolus of 2mg morphine IV every ten minutes until pain free).

Conditions

Breast Cancer; Mastectomy, Modified Radical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Levobupivacaine

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).

Group Type: ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type: DRUG

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

Levobupivacaine + Dexmedetomidine

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).

Group Type: ACTIVE_COMPARATOR

Levobupivacaine + Dexmedetomidine

Intervention Type: DRUG

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

Interventions

Levobupivacaine

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

Intervention Type: DRUG

Levobupivacaine + Dexmedetomidine

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

Intervention Type: DRUG

Other Intervention Names

Chirocaine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Hilde Coppejans

data manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hilde Coppejans, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

University Hospital Antwerp

Edegem, Antwerp, Belgium

Countries

Belgium

Other Identifiers

B300201421166

Identifier Type: REGISTRY

Identifier Source: secondary_id

2014-002589-56

Identifier Type: -

Identifier Source: org_study_id