Pectoral nerve block to reduce pain after breast reduction
Official title: Intraoperative Pectoral Block in Breast Reductions: Reduction in Pain Scores & Elimination of Narcotic Use
Run by Carilion Clinic · NCT07527039 · Data updated 2026-11-12
This trial will test whether giving a PECs II pectoral nerve block to women having breast reduction lets them avoid prescription narcotics while keeping pain under control.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | Carilion Clinic Academic / other |
| Locations | 1 site (Roanoke, Virginia) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | May 2028 |
| Study ends | May 2028 |
| Registry record updated | April 14, 2026 |
| Trial ID | NCT07527039 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–74 undergoing breast reduction for symptomatic macromastia with stable breast size and persistent symptoms despite at least three months of conservative therapy are ideal candidates.
✕Probably not a fit
Patients who are male, outside the age range, not undergoing reduction mammoplasty, unable to receive a pectoral nerve block, or with chronic opioid tolerance may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults scheduled for reduction mammoplasty who meet eligibility are consented preoperatively and randomized by software into two groups: a control group receiving a multimodal pain control (MMPC) plan that includes prescribed narcotics, and an experimental group receiving a PECs II pectoral nerve block plus MMPC without routine narcotic prescriptions. Both groups receive a paper narcotic prescription to preserve blinding and may use it if pain is not controlled. Pain outcomes are collected by patient surveys on postoperative days 1, 3, and 7 using the PROMIS Pain Intensity measure, with secondary outcomes including actual narcotic use and patient satisfaction. The trial is powered for a non-inferiority comparison and plans analysis after enrollment of at least 80 patients.
Why it matters
Potential benefit: If successful, patients could have effective postoperative pain control after breast reduction while using fewer or no prescription narcotics, lowering opioid-related side effects and dependence risk.
How similar studies have gone: Pectoral nerve blocks (including PECs variants) have reduced opioid use and improved pain control in other types of breast surgery, though PECs II specifically for reduction mammoplasty is less extensively studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Carilion Clinic
Roanoke, Virginia, United States Recruiting
Study contacts
- Principal investigator: Anthony Capito, MD — Carilion Clinic
- Study coordinator: Patrick Dugom, MD
- Email: pmdugom@carilionclinic.org
- Phone: 540-655-8133
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.