Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-24 @ 10:32 PM
Study NCT ID:
NCT03040167
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2017-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pectoral Block for Breast Augmentation Surgery
Sponsor:
Organization:
Raw JSON
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Pectoral nerves I block is associated with a significant motor blockade with no dermatomal sensory changes: a prospective volunteer randomized-controlled double-blind study. Can J Anaesth. 2018 Jul;65(7):806-812. doi: 10.1007/s12630-018-1122-2. Epub 2018 Mar 29.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nFor 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* breast augmentation surgery\n* registration at régie d'assurance maladie du Québec (RAMQ) (social services)\n\nExclusion Criteria:\n\n* known bleeding disorder\n* anticoagulant intake\n* infection at site of PEC 1 block\n* pregnant or breast-feeding women\n* allergy to bupivacaine\n* chronic pain including fibromyalgia with regular analgesic consumption\n* under recreational drugs or alcohol at doses above canadian recommendations\n* muscle relaxants intake\n* patients already operated for breast augmentation or mastectomy"}, 'identificationModule': {'nctId': 'NCT03040167', 'acronym': 'BPCAM', 'briefTitle': 'The Pectoral Block for Breast Augmentation Surgery', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': "The Pectoral Block for Breast Augmentation Surgery: a Volunteers' and Patients' Study.", 'orgStudyIdInfo': {'id': '17.091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'PEC 1 block with injection of 0.4 mL/kg of normal saline under echoguidance.', 'interventionNames': ['Procedure: PEC 1 block', 'Drug: Normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group', 'description': 'PEC 1 block with injection of 0.4 mL/kg of 0.25% bupivacaine with 1/400 000 epinephrine under echoguidance.', 'interventionNames': ['Procedure: PEC 1 block', 'Drug: Bupivacaine with epinephrine']}], 'interventions': [{'name': 'PEC 1 block', 'type': 'PROCEDURE', 'otherNames': ['pectoral block', 'pecblock'], 'description': 'Under echoguidance, injection of the substance of interest between the major and minor pectoral muscles.', 'armGroupLabels': ['Control group', 'Treatment group']}, {'name': 'Bupivacaine with epinephrine', 'type': 'DRUG', 'description': 'Treatment group', 'armGroupLabels': ['Treatment group']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Placebo group', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2W 1T8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Saint-Jérôme', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CISSS des Laurentides', 'geoPoint': {'lat': 45.78036, 'lon': -74.00365}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Beaulieu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministere de la Sante et des Services Sociaux', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of anesthesiology', 'investigatorFullName': 'Pierre Beaulieu', 'investigatorAffiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-11-14', 'type': 'RELEASE'}, {'date': '2023-09-21', 'type': 'RESET'}], 'unpostedResponsibleParty': "Centre hospitalier de l'Université de Montréal (CHUM)"}}}}