Effect of Pectoralis Block on Analgesia After Simple Mastectomy

August 10, 2018 updated by: Uma Shastri, Vanderbilt University Medical Center

The Effect of Pectoralis Block on Analgesia After Simple Mastectomy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Pectoralis Block with Ropivacaine
General anesthesia + pectoralis block with ropivacaine injection 30ml of 0.25% (75mg)
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: 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
Placebo Comparator: Pectoralis Block with normal saline
General anesthesia + Pectoralis block with 30ml of normal saline injection
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of Recovery-27 score at baseline
Time Frame: Baseline
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery at baseline
Baseline
Quality of Recovery-27 score at post operative day 1
Time Frame: Post operative day 1
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 1
Post operative day 1
Quality of Recovery-27 scores at post operative day 7
Time Frame: Post operative day 7
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 7
Post operative day 7
Quality of Recovery-27 scores at post operative day 30
Time Frame: Post operative day 30
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 30
Post operative day 30
Quality of Recovery-27 scores at post operative day 90
Time Frame: Post operative day 90
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 90
Post operative day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of Numerical Rating Scale-11 (NRS-11) at rest
Time Frame: 90 days
Comparison of patient reported pain assessment while at rest using the NRS-11 Scale at arrival in PACU, 15 minutes, 30 minutes, 1 hour and 2 hours after arrival in PACU, and postoperative days 1, 7, 30, and 90. The NRS-11 is a 11 point scale when 0 is no pain and 10 is severe pain.
90 days
Comparison of Numerical Rating Scale-11 (NRS-11) with movement
Time Frame: 90 days
Comparison of patient reported pain assessment while with movement using the NRS-11 Scale at arrival in PACU, 15 minutes, 30 minutes, 1 hour and 2 hours after arrival in PACU, and postoperative days 1, 7, 30, and 90. The NRS-11 is a 11 point scale when 0 is no pain and 10 is severe pain.
90 days
Duration of postoperative analgesia
Time Frame: Up to 24 hours
Duration of postoperative analgesia as measured by time in minutes to first intravenous or oral opioid postoperatively.
Up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Uma Shastri, MD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 160419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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