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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03456661
• Other study ID #: 2014-002589-56
• Secondary ID: B300201421166
• Status: Terminated
• Phase: Phase 4
• Start date: May 19, 2014
• Est. completion date: January 12, 2018

Study information

• Verified date: September 2019
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: January 12, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Mastectomy, Modified Radical

Intervention

Drug:
• Levobupivacaine
Infiltration with 0.25% 29,5ml + 0,5ml physiologic serum (total volume 30ml), US guided, using pectoralis block technique.
• Levobupivacaine + Dexmedetomidine
Infiltration with chirocaine 0.25% 29,5ml + 0,5ml dexmedetomidine (50µg) (total volume 30ml), US guided, using pectoralis block technique.

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Onset of postoperative pain	Time between end of general anesthesia and a patients first demand of morphine registrated by PCIA.	24 hours post procedure
Secondary	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
Secondary	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