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

NCT03456661 | Terminated Phase 4

• 2 other identifiers: 2014-002589-56B300201421166
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Mastectomy, Modified Radical

Keywords

Pectoral block; Ultrasound; Mastectomy; Levobupivacaine; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Total postoperative opioid (morphine) consumption

  Milligrams of morphine used by the patient registrated by patient controlled intravenous analgesia delivery device (PCIA) during 24 hours after surgery

  24 hours post procedure

Secondary Outcomes (3)

• Onset of postoperative pain

  24 hours post procedure

• Number of boluses morphine the patient asked for in the first 24 hours postoperative

  24 hours post procedure

• Number of effectively delivered morphine boluses in the first 24 hours postoperatively

  24 hours post procedure

Study Arms (2)

Levobupivacaine

ACTIVE COMPARATOR

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).

Drug: Levobupivacaine

Levobupivacaine + Dexmedetomidine

ACTIVE COMPARATOR

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).

Drug: Levobupivacaine + Dexmedetomidine

Interventions

Levobupivacaine DRUG

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

Also known as: Chirocaine

Levobupivacaine

Levobupivacaine + Dexmedetomidine DRUG

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

Levobupivacaine + Dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women,
• years and older
• American Society of Anesthesiologists 1, 2,3,
• planned for radical mastectomy.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Levobupivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hilde Coppejans, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: data manager

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: March 7, 2018
• Study Start: May 19, 2014
• Primary Completion: January 12, 2018
• Study Completion: January 12, 2018
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

BE (1)