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

Comparison Between Levobupivacaine 0.25% and Levobupivacaine With Dexmedetomidine in Ultrasound Guided Modified Pectoral Nerve Block, a Double Blind Randomised Controlled Trial.

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Mastectomy, Modified Radical
• Intervention / Treatment: Drug: Levobupivacaine; Drug: Levobupivacaine + Dexmedetomidine

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).

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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).	Drug: Levobupivacaine; Infiltration with 0.25% 29,5ml + 0,5ml physiologic serum (total volume 30ml), US guided, using pectoralis block technique.; Other Names: Chirocaine
ACTIVE_COMPARATOR: 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).	Drug: Levobupivacaine + Dexmedetomidine; Infiltration with chirocaine 0.25% 29,5ml + 0,5ml dexmedetomidine (50µg) (total volume 30ml), US guided, using pectoralis block technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of postoperative pain	Time between end of general anesthesia and a patients first demand of morphine registrated by PCIA.	24 hours post procedure
Number of boluses morphine the patient asked for in the first 24 hours postoperative	Amount of times the patient pushed the PCIA button even during lockout time period	24 hours post procedure
Number of effectively delivered morphine boluses in the first 24 hours postoperatively	Amount of times the patient pushed the PCIA button and morphine is delivered.	24 hours post procedure

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 19, 2014
• Primary Completion (ACTUAL): January 12, 2018
• Study Completion (ACTUAL): January 12, 2018

Study Registration Dates

• First Submitted: August 8, 2014
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (ACTUAL): March 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Ultrasound; Dexmedetomidine; Mastectomy; Levobupivacaine; Pectoral block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Levobupivacaine
• Other Study ID Numbers: 2014-002589-56; B300201421166 (REGISTRY: FAGG)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED