Pectoral Block in Breast Reduction for Pain Control
Part of paid clinical trials in Roanoke, Virginia.
- Sponsor
- Carilion Clinic
- Study ID
- NCT07527039
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Macromastia (Symptomatic)
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Pectoral II Nerve Block — PROCEDUREThe 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 — DRUGParticipants 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
Study Details
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.
Key Dates
- Start date
- Apr 1, 2026
- Status verified
- Apr 2026
- Primary completion
- May 31, 2028
- Completion
- May 31, 2028
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Active Comparator: Control groupPatients 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 groupPatients 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.
Primary Outcome Measure
Postoperative pain control regimen [ Time Frame: From enrollment to completion of the study is approximately 3 weeks ]
Central Contacts
- Patrick Dugom, MD540-655-8133
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Carilion Clinic | Roanoke | Virginia | 24014 | - |