Recruiting

PECs IIPectoral Block in Breast Reduction for Pain Control

Sponsor:

Carilion Clinic

Code:

NCT07527039

Conditions

Macromastia (Symptomatic)

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pectoral II Nerve Block

Post Operative Pain Relievers

Study Details

Brief summary:

A reduction mammoplasty is a commonly performed procedure for patients with symptomatic macromastia. The procedure involves removing breast parenchyma for an overall reduction in breast size and to alleviate patient symptoms, such as back/neck pain, rashes in the inframammary fold, and bra strap indentation. It is well documented in the literature that this procedure has a statistically significant reduction in patient symptoms. Postoperatively, it has been within the norm to prescribe narcotics in order to alleviate post-procedural pain. Recently, however, the research realm has advocated a non-narcotic multimodal pain control (MMPC) approach to minimize narcotic usage. Narcotic use is associated with increased costs in the healthcare system due to reported heightened pain scores for extended duration, constipation, nausea, vomiting, opiate dependence among other factors associated with increased morbidity.

The goal of this study is to determine if PECs II (pectoral block type II) block alone is non-inferior to the standard multimodal pain control with narcotics for postoperative pain reduction in breast reduction.

Conditions

Macromastia (Symptomatic)

Study ID

NCT07527039

Start date

Apr 1, 2026

Status verified date

Apr, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Undergoing breast reduction surgery
Women older than age 18 and under age 75
Stable breast size for at least 1 year
Member has persistent symptoms in at least two of the anatomical body areas below, directly attributed to macromastia and affecting daily activities for at least 1 year:

Headaches; Pain in neck; Pain in shoulders; Pain in upper back; Painful kyphosis documented by X-rays; Pain/discomfort/ulceration from bra straps cutting into shoulders; Skin breakdown (severe soft tissue infection, tissue necrosis, ulceration hemorrhage) from overlying breast tissue; Upper extremity parasthesia

Patient has evidence of severe breast hypertrophy that is documented by frontal and side profile photographs
Pain symptoms persist as documented by the physician despite at least a 3-month trial of therapeutic measures such as:

Analgesic/non-steroidal anti-inflammatory drugs (NSAIDs) interventions and/or muscle relaxants Dermatologic therapy of ulcers, necrosis and refractory infection Physical therapy/exercises/posturing maneuvers Supportive devices (e.g., proper bra support, wide bra straps) Chiropractic care or osteopathic manipulative treatment Medically supervised weight loss program Orthopedic or spine surgeon evaluation of spinal pain

Breast Reduction is likely to cause a reduction in patient symptoms
Women 50 years of age or older are required to have a mammogram that was negative for cancer performed within the two years prior to the date of the planned reduction mammoplasty
Greater than 40 kg in weight

Exclusion Criteria:

History of chronic pain controlled with prescribed narcotics
English as non-primary language
No access to email or internet
Positive pre-surgery pregnancy test
Women not of ages 18-75
Less than 40 kg in weight

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Control group

Patients receive wetting solution with lidocaine and epinephrine in both breasts at the beginning of the case for analgesia and hemostasis. No nerve block is administered intraoperatively. As needed narcotic paper prescription is provided, same as in the experimental group.

experimental: PEC II block group

Patients receive wetting solution with only epinephrine in both breasts at the beginning of the case for hemostasis. The patient will be administered 20 cc's of local anesthetic (0.25% bupivacaine with epinephrine), with 20 mcg dexmedetomidine and 4 mg dexamethasone added per breast. A total of 40 cc's of 0.25% bupivacaine will be used. This will be performed as a Pectoral II block. As needed narcotic paper prescription is provided, same as in the control group.

Interventions

Pectoral II Nerve Block

The Pectoral II block is a modified Pectoral I block and can be achieved using a single needle stick. Local anesthetic placement is between the pectoralis major and pectoralis minor as for a Pecs I block and then between pectoralis minor and serratus anterior. The second portion of the procedure will block the anterior cutaneous branches of intercostal nerves 3 to 6, the intercostobrachial nerves, and the long thoracic nerve.

Post Operative Pain Relievers

Participants will receive the same postoperative instructions in both groups. Participants will be instructed to alternate acetaminophen and ibuprofen every 6 hours. Participants will also receive a paper prescription for a narcotic pain medication if pain is not adequately controlled by the over-the-counter products

Primary outcome measure

Postoperative pain control regimen [ Time Frame: From enrollment to completion of the study is approximately 3 weeks ]
Postoperative PROMIS pain intensity survey [ Time Frame: Surveys collected on days 1, 3, and 7 post-surgery. From enrollment to completion of the study is approximately 3 weeks ]

Central Contacts and Locations

Central contacts

Patrick Dugom, MD

540-655-8133 pmdugom@carilionclinic.org

Locations

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24014

More Information

Sponsor

Carilion Clinic

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

Macromastia
Pectoral nerve block
PEC II block
Opioid reduction postoperatively
breast reduction
reduction mammaplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2026-04-14.