Recruiting

PECS Block

Sponsor:

Main Line Health

Code:

NCT04086394

Conditions

Breast Cancer

Postoperative Pain

Opioid Use

Local Anesthesia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Pectoral Nerve Block

Surgery without Nerve Block

Study Details

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

Study ID

NCT04086394

Start date

Sep 1, 2019

Status verified date

Feb, 2020

Completion date

Nov 1, 2020

Anticipated

Primary completion date

Sep 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PECS Block

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

sham comparator: Control

Patient who was randomly selected not to receive intraoperative nerve block

Interventions

Pectoral Nerve Block

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

Surgery without Nerve Block

Patient's underwent indicated procedure without regional pectoralis nerve block

Primary outcome measure

  • Postoperative pain [ Time Frame: Immediately postoperatively until day 3 ]

Central Contacts and Locations

Central contacts

Locations

Kaitlyn Kennard

Recruiting

Philadelphia, Pennsylvania, United States, 19147

Contacts

Principal Investigator:

Kaitlyn Kennard, MD

More Information

Sponsor

Main Line Health

Last update posted

Feb 20, 2020

Last verified

Feb, 2020

Keywords

  • Pain
  • Narcotics
  • Nerve block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Main Line Health on 2020-02-20.