PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery

December 6, 2024 updated by: Washington University School of Medicine
In this double blinded randomized placebo-controlled trial, 160 subjects scheduled for breast surgery involving the axilla will be administered a multimodal pain regimen including acetaminophen, dexamethasone, celecoxib, and gabapentin. 80 subjects will also receive a Pectoral Nerve blocks I and II (PECS I and II block) preoperatively.

Study Overview

Status

Status

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

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.

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.
134

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 2

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
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

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:

  • Scheduled to undergo elective breast cancer surgeries at Barnes-Jewish Hospital:

    • unilateral axillary dissection
    • unilateral modified radical mastectomy
    • mastectomy with same day unilateral reconstruction
    • unilateral sentinel lymph node biopsy (SLNB)
    • partial mastectomy with unilateral SLNB
    • simple mastectomy with unilateral SLNB
  • At least 18 years of age.
  • Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.
  • Enrollment in the SATISFY-SOS study (WUSTL IRB# 201203088, NCT02032030).

Exclusion Criteria:

  • Planned for bilateral axillary or bilateral reconstruction surgery.
  • Previous surgery on the surgical breast and/or axilla with the exception of partial mastectomy or sentinel lymph node biopsy
  • Pre-existing pain in the axilla affecting the ability to use extremity for activities of daily living or requiring medication for treatment.
  • Current or past medical history of liver disease or cirrhosis with an elevated INR >1.4 or currently elevated transaminase levels.
  • Known contraindications to peripheral nerve block placement.
  • Pregnant or breastfeeding.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition
  • Planned additional surgery to the surgical breast or axilla in the next year (exception would be minor surgery to breast but not axilla such as simple tissue expander replacement or lumpectomy)

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: Preoperative PECS blocks
  • PECS I & II block will be administered preoperatively
  • For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)
  • To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number
  • Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist
Drug: Bupivacaine
-Given after general anesthesia
Other Names:
  • Bupivacaine hydrochloride
Drug: Gabapentin
  • As per routine care
  • Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.
Drug: Celecoxib
  • As per routine care
  • Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.
  • Naproxen will be substituted for celecoxib in patients with sulfa allergies.
Drug: Acetaminophen
-As per routine care
Drug: Midazolam
-As per routine care
Drug: Fentanyl
-As per routine care
Placebo Comparator: Placebo PECS blocks
  • A sham block (normal saline) will be placed preoperatively
  • To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number.
  • Perioperative analgesic regimen will be encouraged. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative holding area. On the day of surgery all patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist.
Drug: Gabapentin
  • As per routine care
  • Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.
Drug: Celecoxib
  • As per routine care
  • Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.
  • Naproxen will be substituted for celecoxib in patients with sulfa allergies.
Drug: Acetaminophen
-As per routine care
Drug: Midazolam
-As per routine care
Drug: Fentanyl
-As per routine care

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
Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
Time Frame: At 1 year
  • The participant is asked to rate their pain by circling the one number that best describes their pain at its worst in the past week.
  • 0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain.
At 1 year
Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
Time Frame: At 1 year
  • The participant is asked to rate their pain by circling the one number that best describes their pain on the average.
  • 0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain.
At 1 year
Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year
Time Frame: At 1 year
  • The participant is asked circle the one number that describes how much, during the past week pain has interfered with general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, sleep, and enjoyment of life.
  • 0=does not interference and 10 = completely interferes. The higher number indicates more interference from pain.
  • The scores for each subsection will be averaged.
At 1 year

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
Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure
Time Frame: At baseline and 1 year post-surgery
  • The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).
  • The higher the score the better quality of life.
  • Scores are standardized to a mean of 50 with a range of -0.809-70.71.
At baseline and 1 year post-surgery
Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure
Time Frame: At baseline and 1 year post-surgery
  • The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).
  • The higher the score the better quality of life.
  • Scores are standardized to a mean of 50 with a range of -1.465-77.09.
At baseline and 1 year post-surgery

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.
Washington University School of Medicine

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: Ryan C Guffey, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
June 7, 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.
February 25, 2021

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.
February 25, 2021

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 8, 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.
March 14, 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.
March 21, 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.
March 25, 2025

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.
December 6, 2024

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.
December 1, 2024

More Information

Terms related to this study

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.
  • 201703053

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings