Clinical trial NCT03456661: Comparison Between Levobupivacaine and Levobupivacaine With Dexmedetomidine in Ultrasound Guided Pectoral Nerve Block
Official title: Comparison Between Levobupivacaine 0.25% and Levobupivacaine With Dexmedetomidine in Ultrasound Guided Modified Pectoral Nerve Block, a Double Blind Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Breast Cancer
Mastectomy, Modified Radical
Keywords: Pectoral block
Ultrasound
Mastectomy
Levobupivacaine
Dexmedetomidine
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Total postoperative opioid (morphine) consumption
timeFrame: 24 hours post procedure
Secondary outcomes:
measure: Onset of postoperative pain
timeFrame: 24 hours post procedure
measure: Number of boluses morphine the patient asked for in the first 24 hours postoperative
timeFrame: 24 hours post procedure
measure: Number of effectively delivered morphine boluses in the first 24 hours postoperatively
timeFrame: 24 hours post procedure
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Hilde Coppejans, MD
role: PRINCIPAL_INVESTIGATOR
References: