Breast Cancer, Mastectomy, Modified Radical
Conditions
Keywords
Pectoral block, Ultrasound, Mastectomy, Levobupivacaine, Dexmedetomidine
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).
Interventions
DRUGLevobupivacaine
Infiltration with 0.25% 29,5ml + 0,5ml physiologic serum (total volume 30ml), US guided, using pectoralis block technique.
Infiltration with chirocaine 0.25% 29,5ml + 0,5ml dexmedetomidine (50µg) (total volume 30ml), US guided, using pectoralis block technique.
Sponsors
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative opioid (morphine) consumption | 24 hours post procedure | Milligrams of morphine used by the patient registrated by patient controlled intravenous analgesia delivery device (PCIA) during 24 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset of postoperative pain | 24 hours post procedure | Time between end of general anesthesia and a patients first demand of morphine registrated by PCIA. |
| Number of boluses morphine the patient asked for in the first 24 hours postoperative | 24 hours post procedure | Amount of times the patient pushed the PCIA button even during lockout time period |
| Number of effectively delivered morphine boluses in the first 24 hours postoperatively | 24 hours post procedure | Amount of times the patient pushed the PCIA button and morphine is delivered. |
Countries
Belgium
Outcome results
None listed