Effect of Pectoralis Block on Analgesia After Simple Mastectomy

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2019-04-01

Brief Summary

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The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.

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Detailed Description

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The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The concept involves injecting local anesthetic near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II). This is a prospective, double-blinded, randomized controlled trial in subjects undergoing mastectomy under general anesthesia. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.

Conditions

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Mastectomy Nerve Block Analgesia, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned to one of two of the following groups for the duration of the study.

1. General anesthesia + pectoralis block with Ropivacaine 30ml of 0.25% (75mg)
2. General anesthesia + sham block with 30ml of normal saline

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Participants, care providers, investigators, and observers who record central measurements will be blinded to group allocation.

Study Groups

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Pectoralis Block with Ropivacaine

General anesthesia + pectoralis block with ropivacaine injection 30ml of 0.25% (75mg)

Group Type ACTIVE_COMPARATOR

Pectoralis block

Intervention Type PROCEDURE

Pectoralis block involving injection near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II).

Ropivacaine Injection

Intervention Type DRUG

Pectoralis block involving injection of ropivacaine injection 30ml of 0,25% (75 mg) near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior

Pectoralis Block with normal saline

General anesthesia + Pectoralis block with 30ml of normal saline injection

Group Type PLACEBO_COMPARATOR

Pectoralis block

Intervention Type PROCEDURE

Pectoralis block involving injection near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II).

Normal saline injection

Intervention Type DRUG

Pectoralis block involving injection of normal saline 30ml near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior

Interventions

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Pectoralis block

Pectoralis block involving injection near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II).

Intervention Type PROCEDURE

Normal saline injection

Pectoralis block involving injection of normal saline 30ml near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior

Intervention Type DRUG

Ropivacaine Injection

Pectoralis block involving injection of ropivacaine injection 30ml of 0,25% (75 mg) near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA 1, 2, and 3 patients (According to ASA classification of comorbid conditions and general health)
* Patients undergoing simple mastectomy

Exclusion Criteria

* -Patient Refusal
* Allergy to local anesthetics
* Inability to communicate in English
* Use of 8 mg morphine equivalents or greater currently and for a period of longer then 2 weeks prior to surgery
* Existing nerve injuries or sensory deficits
* Conversion to anesthesia via an endotracheal tube

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No