The Analgesic Efficacy of the Pectoral Block After Mastectomy

NCT ID: NCT02916381

Last Updated: 2019-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-04-30

Brief Summary

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Unilateral mastectomy is associated with moderate to severe postoperative pain. A new regional anaesthetic technique has been recently described, call the PEC block. This technique consists of injecting local anaesthetic between different muscles of the chest in order to relieve postoperative pain. The investigators aim to verify that this technique has a clinical relevant postoperative analgesic effect. For that purpose, the investigators will randomise 50 patients scheduled to undergo unilateral mastectomy into two groups: one group will receive a PEC block after the induction of the general anaesthesia under ultrasound guidance, while the other group will not have this regional procedure.

Detailed Description

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Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PEC block

Ultrasound-guided PEC block after induction of general anaesthesia.

Group Type EXPERIMENTAL

PEC block + General anaesthesia

Intervention Type PROCEDURE

Patients will receive an ultrasound-guided PEC block after the induction of general anaesthesia.

Control

No ultrasound-guided PEC block; only general anaesthesia will be provided.

Group Type SHAM_COMPARATOR

General anaesthesia

Intervention Type PROCEDURE

Interventions

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PEC block + General anaesthesia

Patients will receive an ultrasound-guided PEC block after the induction of general anaesthesia.

Intervention Type PROCEDURE

General anaesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA physical status I-III
* Age ≥ 18
* Patients undergoing unilateral mastectomy

Exclusion Criteria

* Contraindications to regional block
* Pregnancy
* Inability to give informed consent
* History of alcohol or drug dependence/abuse
* History of long term opioid intake or chronic pain disorder
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Eric Albrecht

PD Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Albrecht

Role: PRINCIPAL_INVESTIGATOR

CHUV

Locations

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Lausanne University Hospital

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CER 2016-01413

Identifier Type: -

Identifier Source: org_study_id

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