The Pectoral Block for Breast Augmentation Surgery

Pain, Postoperative Clinical Trial

— BPCAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040167
• Other study ID #: 17.091
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2017
• Est. completion date: March 29, 2018

Study information

• Verified date: March 2018
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 29, 2018
• Est. primary completion date: March 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia; Regional
• Pain, Postoperative

Intervention

Procedure:
• PEC 1 block
Under echoguidance, injection of the substance of interest between the major and minor pectoral muscles.

Drug:
• Bupivacaine with epinephrine
Treatment group
• Normal saline
Placebo group

Locations

Country	Name	City	State
Canada	CHUM	Montreal	Quebec
Canada	CISSS des Laurentides	Saint Jérôme	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Pierre Beaulieu	Ministere de la Sante et des Services Sociaux

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain score at rest	Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)	Within the first 10 min after arrival to the postanesthesia care unit (PACU)
Secondary	Postoperative pain score on movement	Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)	Within the first 10 min after arrival to the postanesthesia care unit (PACU)
Secondary	Postoperative pain score at rest	Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)	15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU
Secondary	Incidence of nausea and/or vomiting	Presence or absence of nausea and/or vomiting	15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU
Secondary	Surgical bleeding	Presence or not of surgical bleeding from wounds, drains eventually leading to surgical exploration	After surgery for 24 hours
Secondary	Hematoma	Presence or absence of hematoma at PEC 1 block injection	After surgery for 24 hours
Secondary	Postoperative well-being	Analgesic intake	At 24 hours after surgery