Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)

June 5, 2023 updated by: Spectrum Health Hospitals

Paravertebral Block Versus Pectoral Nerve Block for Analgesia Following Mastectomy

The purpose of this study is to compare two standard methods of pain control management used at Spectrum Health for patients undergoing breast surgery. The two methods being compared are the paravertebral block (PVB) and the pectoral nerve block (PEC). Postoperative pain control is essential following any major operative procedure. A variety of methods have been used to ensure adequate pain control, each with its own advantages and risks. Increasingly, attention has focused on regional methods of analgesia, which may allow for reduction in systemic narcotic use and their associated complications. Proposed benefits of regional analgesia and a resultant reduction in narcotic use include decreased risk of cancer progression, decreased length of stay, and decreased risk of ileus.

Study Overview

Status

Status

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

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 purpose of this study is to compare the clinical profiles of two currently acceptable analgesia techniques. The most common regional block used to achieve postoperative analgesia following mastectomy is the paravertebral block, during which local anesthetic is injected into the paravertebral space which contains the thoracic spinal nerves, between the costotransverse ligament and the pleura. At our institution there has been recent interest in an alternative regional block. The pectoral nerve block is performed by injecting anesthetic between the pectoralis major and the pectoralis minor (PECs I) or between the pectoralis minor and the serratus anterior (PEC II).

The proposed advantage of the pectoral nerve block for regional anesthesia during breast surgery is equal analgesic efficacy with fewer potential complications.

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

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 3

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
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Esther L Peariso

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

Description

Inclusion Criteria:

  • Female patients ≥ 18 years of age
  • Total mastectomy or partial mastectomy with or without reconstruction OR planned lumpectomy.
  • Patient determined by their surgeon as medically able to receive a regional block for post-operative analgesia
  • Patient agrees to participate in the study and signs informed consent

Exclusion Criteria:

  • Neoadjuvant radiation therapy
  • Stage IV cancer
  • Previous breast surgery (excluding percutaneous biopsies of all types)
  • History of either PVB or PEC procedures
  • Planned general anesthesia use during surgery
  • Allergies to ropivacaine, midazolam, fentanyl, or propofol
  • Pregnant women
  • Prisoners
  • Adults unable to consent
  • Non-English-speaking patients

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: None (Open Label)

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: Paravertebral Block
The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)
Drug: Paravertebral Block
20-30 mL 0.5% Ropivacaine
Other Names:
  • PVB
Active Comparator: Pectoral Nerve Block
The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)
Drug: Pectoral Nerve Block
20-30 mL 0.5% Ropivacaine
Other Names:
  • PEC

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
Intraoperative Narcotic Use
Time Frame: intraoperatively, average of about 1 hour
Participants for whom Narcotics were used for pain during surgery
intraoperatively, average of about 1 hour
Post Anesthesia Care Unit (PACU) Narcotic Use
Time Frame: in PACU, generally 1-3 hours
Participants for whom Narcotics were used in PACU
in PACU, generally 1-3 hours
Postoperative Narcotic Use
Time Frame: First 24 hours post-PACU (or until discharge)
Participants for whom Narcotics were used postoperatively
First 24 hours post-PACU (or until discharge)

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
Pain Control Measured by Length of Operation
Time Frame: intraoperative
Measuring pain control by how long (in minutes) patient is in surgery
intraoperative
Pain Control Measured by Estimated Blood Loss
Time Frame: intraoperative
Measuring blood loss (in ml) during surgery
intraoperative
Participants With Postoperative Nausea
Time Frame: 2 weeks postoperative
count of participants who reported nausea after surgery
2 weeks postoperative
Pain Control Measured by Pain Scale
Time Frame: 2 weeks postoperative
Pain measured on scale of one to ten, one being least amount of pain and ten the greatest.
2 weeks postoperative
Pain Control Measured by the Use of Pain Pills Postoperatively
Time Frame: 2 weeks postoperative
Participants who used narcotic pain pills postoperatively
2 weeks postoperative
Pain Control Measured by Calls to Physicians Office Relating to Pain
Time Frame: 2 weeks postoperative
Number of phone calls made to physician office regarding pain
2 weeks postoperative

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.
Spectrum Health Hospitals

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: Marianne Melink, MD, Spectrum Health Hospitals

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 (Actual)

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.
March 9, 2017

Primary Completion (Actual)

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.
May 21, 2019

Study Completion (Actual)

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.
May 21, 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 1, 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 11, 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 15, 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.
June 6, 2023

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.
June 5, 2023

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.
June 1, 2023

More Information

Terms related to this study

Keywords

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.
  • 2016-306

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

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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