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
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking Description:||Single blinded randomized control trial in which patient was unaware of treatment arm|
|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|
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
- Postoperative pain [ Time Frame: Immediately postoperatively until day 3 ]VAS pain scores used to assess postoperative pain
- Postoperative Narcotic Use [ Time Frame: 72 hours ]Amount of pain medication in morphine equivalents used after surgery until day 3
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
|Contact: Kaitlyn Kennard, MDemail@example.com|
|Contact: Robin Ciocca, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19147|
|Contact: Kaitlyn Kennard, MD 610-642-1908 email@example.com|
|Principal Investigator: Kaitlyn Kennard, MD|
|Principal Investigator: Robin Ciocca, MD|
|Principal Investigator: Jennifer Sabol, MD|
|Principal Investigator: Ned Carp, MD|