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Use of PECS Block in Partial Mastectomy for Postoperative Pain Control and Mitigation of Narcotic Use- A Randomized Control Trial (PECS)

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ClinicalTrials.gov Identifier: NCT04086394
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Kaitlyn Kennard MD, Main Line Health

Brief Summary:

The aim of this study is to evaluate patients who are undergoing partial mastectomy or removal of breast tissue and see if a pectoralis nerve block (PECS) can provide a meaningful improvement in postoperative pain control over standard pain medication. The hope is that this will decrease the need for postoperative narcotics. Prior studies have shown improved pain control using a PECS block in patients who undergo a mastectomy. PECS block is a procedure in which local anesthesia, similar to that used by dentists, is injected in the muscles of your chest and arm pit during your surgical procedure while you are asleep. This anesthetizes the nerves in the area which decreases pain. The local anesthetic used is called Marcaine. Marcaine is the brand name for bupivacaine hydrochloride which is an anesthetic known for its long duration in comparison to lidocaine.

It is known that postoperative pain is a risk factor for chronic pain which is tied to increased narcotic use. Due to the opioid epidemic considerable time and research has gone into decreasing opioid use particularly in post-operative period. The PECS block procedure involves injecting local anesthesia between two chest muscles called pectoralis major and pectoralis minor. There is an additional injection between the pectoralis minor and serratus anterior which is another muscle of the chest.

This study will be conducted at Lankenau Medical Center of Main Line Health. You have been selected since you will be undergoing a partial mastectomy (removal of a part of your breast). It is believed that PECS block has the potential to benefit your postoperative pain control. A total of 130 patients will be recruited and 65 will be placed into the treatment arm (receive intraoperative nerve block) and 65 will be placed into the non- treatment arm (no nerve block) for comparison.


Condition or disease Intervention/treatment Phase
Breast Cancer Partial Mastectomy Postoperative Pain Opioid Use Local Anesthesia Procedure: Pectoral Nerve Block Procedure: Surgery without Nerve Block Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Masking Description: Single blinded randomized control trial in which patient was unaware of treatment arm
Primary Purpose: Prevention
Official Title: Use of PECS Block in Partial Mastectomy for Postoperative Pain Control and Mitigation of Narcotic Use- A Randomized Control Trial
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Experimental: PECS Block
Group who was randomly selected to receive the intraoperative nerve block.
Procedure: Pectoral Nerve Block
Patients who were given 20 cc of 0.25% Marcaine as part of the pectoralis nerve block

Sham Comparator: Control
Patient who was randomly selected not to receive intraoperative nerve block
Procedure: Surgery without Nerve Block
Patient's underwent indicated procedure without regional pectoralis nerve block




Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: Immediately postoperatively until day 3 ]
    VAS pain scores used to assess postoperative pain


Secondary Outcome Measures :
  1. Postoperative Narcotic Use [ Time Frame: 72 hours ]
    Amount of pain medication in morphine equivalents used after surgery until day 3



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion criteria are patients are undergoing a partial mastectomy or excisional biopsy. Patients may undergo additional procedures such as sentinel lymph node biopsy or axillary lymph node dissection which will be recorded.

Exclusion Criteria:

  • Chronic Pain, Presence of Breast Implants prior to surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086394


Contacts
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Contact: Kaitlyn Kennard, MD 610-642-1908 kennardk@mlhs.org
Contact: Robin Ciocca, MD 610-642-1908 cioccar@mlhs.org

Locations
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United States, Pennsylvania
Kaitlyn Kennard Recruiting
Philadelphia, Pennsylvania, United States, 19147
Contact: Kaitlyn Kennard, MD    610-642-1908    kennardk@mlhs.org   
Principal Investigator: Kaitlyn Kennard, MD         
Principal Investigator: Robin Ciocca, MD         
Principal Investigator: Jennifer Sabol, MD         
Principal Investigator: Ned Carp, MD         
Sponsors and Collaborators
Main Line Health

Publications:

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Responsible Party: Kaitlyn Kennard MD, Post Doctoral Research Fellow, Main Line Health
ClinicalTrials.gov Identifier: NCT04086394     History of Changes
Other Study ID Numbers: R20-3896L
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaitlyn Kennard MD, Main Line Health:
Pain
Narcotics
Nerve block
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents