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Intraoperative Pectoral Block in Breast Reductions: Reduction in Pain Scores & Elimination of Narcotic Use

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Virginia
Carilion Clinic
RECRUITING
Roanoke
Contact Information
Primary
Patrick Dugom, MD
pmdugom@carilionclinic.org
540-655-8133
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2028-05
Participants
Target number of participants: 80
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Carilion Clinic

This content was sourced from clinicaltrials.gov