Trial | NCT03040167  Report issue

Title

The Pectoral Block for Breast Augmentation Surgery
The Pectoral Block for Breast Augmentation Surgery: a Volunteers' and Patients' Study.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
The pectoral block is a recently developed regional anesthetic technique that can be used for the treatment of postoperative pain after breast surgery. Injection of local anesthetic between the major and the minor pectoral muscles is defined as the pectoral (PEC) 1 block. This block has not been well characterized in terms of its blocking effects on motor and sensitive nerves (medial and lateral pectoral nerves and intercostal nerves). This clinical trial is divided into two sections: a volunteer study and a patient study.

For the volunteer study, the aim is to assess the sensory territory affected by injection of local anesthetics through a PEC 1 block and to assess motor function in terms of strength of adduction of the affected limb using a dynamometer.

In a prospective, randomized, controlled and double blind study, the aim is to assess the postoperative pain relieving properties of the PEC 1 block in patients undergoing bilateral breast augmentation surgery.
Study Started
Oct 01
2017
Primary Completion
Mar 12
2018
Study Completion
Mar 29
2018
Last Update
Dec 10
2019

Drug Bupivacaine with epinephrine

Treatment group

Drug Normal saline

Placebo group

Procedure PEC 1 block

Under echoguidance, injection of the substance of interest between the major and minor pectoral muscles.

  • Other names: pectoral block, pecblock

Control group Placebo Comparator

PEC 1 block with injection of 0.4 mL/kg of normal saline under echoguidance.

Treatment group Active Comparator

PEC 1 block with injection of 0.4 mL/kg of 0.25% bupivacaine with 1/400 000 epinephrine under echoguidance.

Criteria 

Inclusion Criteria:

breast augmentation surgery
registration at régie d'assurance maladie du Québec (RAMQ) (social services)

Exclusion Criteria:

known bleeding disorder
anticoagulant intake
infection at site of PEC 1 block
pregnant or breast-feeding women
allergy to bupivacaine
chronic pain including fibromyalgia with regular analgesic consumption
under recreational drugs or alcohol at doses above canadian recommendations
muscle relaxants intake
patients already operated for breast augmentation or mastectomy
No Results Posted