PECS Block in Partial Mastectomy for Postoperative Pain Control

NCT04086394 | Unknown DMC

• 1 other identifier: R20-3896L
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Postoperative Pain; Opioid Use; Local Anesthesia

Keywords

Pain; Narcotics; Nerve block

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  Visual Analogue Pain scores scaled from 1-10 with 1 being no pain and 10 being worst pain of one's life. This scale is used to assess postoperative pain. Scores will be compared between the two groups.

  Immediately postoperatively until day 3

Secondary Outcomes (1)

• Postoperative Narcotic Use

  72 hours

Study Arms (2)

PECS Block

EXPERIMENTAL

Group who was randomly selected to receive the intraoperative nerve block.

Procedure: Pectoral Nerve Block

Control

SHAM COMPARATOR

Patient who was randomly selected not to receive intraoperative nerve block

Procedure: Surgery without Nerve Block

Interventions

Pectoral Nerve Block PROCEDURE

Patients who were given 20 cc of 0.25% Marcaine as part of the pectoralis nerve block

PECS Block

Surgery without Nerve Block PROCEDURE

Patient's underwent indicated procedure without regional pectoralis nerve block

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Chronic Pain, Presence of Breast Implants prior to surgery

Sponsors & Collaborators

• Main Line Health: lead

Study Sites (1)

Kaitlyn Kennard

Philadelphia, Pennsylvania, 19147, United States

RECRUITING

Related Publications (7)

• Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.

  PMID: 25376971 BACKGROUND

• Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.

  PMID: 21831090 BACKGROUND

• Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.

  PMID: 27543533 BACKGROUND

• Kumar S, Goel D, Sharma SK, Ahmad S, Dwivedi P, Deo N, Rani R. A randomised controlled study of the post-operative analgesic efficacy of ultrasound-guided pectoral nerve block in the first 24 h after modified radical mastectomy. Indian J Anaesth. 2018 Jun;62(6):436-442. doi: 10.4103/ija.IJA_523_17.

  PMID: 29962525 BACKGROUND

• Zhao J, Han F, Yang Y, Li H, Li Z. Pectoral nerve block in anesthesia for modified radical mastectomy: A meta-analysis based on randomized controlled trials. Medicine (Baltimore). 2019 May;98(18):e15423. doi: 10.1097/MD.0000000000015423.

  PMID: 31045802 BACKGROUND

• Senapathi TGA, Widnyana IMG, Aribawa IGNM, Jaya AAGPS, Junaedi IMD. Combined ultrasound-guided Pecs II block and general anesthesia are effective for reducing pain from modified radical mastectomy. J Pain Res. 2019 Apr 26;12:1353-1358. doi: 10.2147/JPR.S197669. eCollection 2019.

  PMID: 31114311 BACKGROUND

• Versyck B, van Geffen GJ, Chin KJ. Analgesic efficacy of the Pecs II block: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):663-673. doi: 10.1111/anae.14607.

  PMID: 30957884 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Pain

Interventions

Surgical Procedures, Operative; Nerve Block

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures

Central Study Contacts

Kaitlyn Kennard, MD

CONTACT

610-642-1908; kennardk@mlhs.org

Robin Ciocca, MD

CONTACT

610-642-1908; cioccar@mlhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded randomized control trial in which patient was unaware of treatment arm
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Doctoral Research Fellow

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 11, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: November 1, 2020
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)