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Effect of Pectoralis Block on Analgesia After Simple Mastectomy

NCT03143530 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2018-08-14

No results posted yet for this study

Summary

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.

Conditions

  • Mastectomy
  • Nerve Block
  • Analgesia, Postoperative

Interventions

PROCEDURE

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).

DRUG

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

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

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Uma Shastri, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-31
Primary Completion
2019-03-01
Completion
2019-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03143530 on ClinicalTrials.gov