Pectoral Block in Breast Reduction for Pain Control

NCT07527039 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB-23-2101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Postoperative pain control regimen

  Participants are administered postoperative surveys on days 1, 3, and 7. These surveys assess type of analgesic medication usage and frequency. The primary purpose is to assess narcotic usage between the two groups to observe a reduction or elimination in narcotic usage in the control group

  From enrollment to completion of the study is approximately 3 weeks

• Postoperative PROMIS pain intensity survey

  Participants are administered a postoperative survey on days 1, 3, and 7. This survey asks participants to rate their pain at its worst, the average intensity level, and the level of pain intensity while taking the survey. This is a numbered survey from 1-5 with 1=no pain, 2=mild, 3=moderate, 4=severe, and 5= very severe

  Surveys collected on days 1, 3, and 7 post-surgery. From enrollment to completion of the study is approximately 3 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Drug: Post Operative Pain Relievers

PEC II block group

EXPERIMENTAL

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.

Procedure: Pectoral II Nerve Block; Drug: Post Operative Pain Relievers

Interventions

Pectoral II Nerve Block PROCEDURE

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.

PEC II block group

Post Operative Pain Relievers DRUG

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

Control group; PEC II block group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Only participants with breasts, and more specifically symptomatic macromastia, qualify for the study. This therefore only includes females as potential participants.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24014, United States

RECRUITING

Related Publications (8)

• Wang K, Zhang X, Zhang T, Yue H, Sun S, Zhao H, Zhou P. The Efficacy of Ultrasound-guided Type II Pectoral Nerve Blocks in Perioperative Pain Management for Immediate Reconstruction After Modified Radical Mastectomy: A Prospective, Randomized Study. Clin J Pain. 2018 Mar;34(3):231-236. doi: 10.1097/AJP.0000000000000529. PMID: 28654558.

  BACKGROUND

• Sercan O, Karaveli A, Ozmen S, Uslu A. Comparison of the Effects of Pectoral Nerve Block and Local Infiltration Anesthesia on Postoperative Pain for Breast Reduction Surgery: A Prospective Observational Study. Eurasian J Med. 2021 Jun;53(2):102-107. doi: 10.5152/eurasianjmed.2021.20111. PMID: 34177291; PMCID: PMC8184032.

  BACKGROUND

• Nguyen, Minh MD; Bhardwaj, Priya MD; Goulart, Micheline MD; Huayllani, Maria T. MD; Arredondo, Sean MD; Mitchell, Kerry-Ann S. MD, PhD; Lehrman, Craig R. MD. Effectiveness of Pectoral Nerve Block in Breast Reduction: A Single Institution Experience. Plastic and Reconstructive Surgery - Global Open 10(10S):p 58, October 2022. | DOI: 10.1097/01.GOX.0000898612.51965.a1

  BACKGROUND

• Aarab Y, Ramin S, Odonnat T, Garnier O, Boissin A, Molinari N, Marin G, Perrigault PF, Cuvillon P, Chanques G. Pectoral Nerve Blocks for Breast Augmentation Surgery: A Randomized, Double-blind, Dual-centered Controlled Trial. Anesthesiology. 2021 Sep 1;135(3):442-453. doi: 10.1097/ALN.0000000000003855. PMID: 34195767.

  BACKGROUND

• Yesiltas S, Türköz A, Çal m M, Y lmaz S, Esen A, Da kaya H, Karaaslan K. Comparison of serratus plane block alone and in combination with pectoral type 1 block for breast cancer surgery: a randomized controlled study. Hippokratia. 2021 Jan-Mar;25(1):8-14. PMID: 35221650; PMCID: PMC8877920.

  BACKGROUND

• Taylor, George A. MD, MS1; Panichella, Juliet C. MBA2; Neusner, Alex MD3; Lo, Alexis MD4; Vazquez, Daniella2; Zhao, Huaqing PhD, MS2; Trehan, Gaurav MD5; Livelsberger, Jon DO5; Gassman, Andrew A. MD6. Pain Control after Reduction Mammaplasty with Combination Bupivacaine and Dexamethasone Regional Block: A Randomized Controlled Trial. Plastic and Reconstructive Surgery 152(2):p 217e-226e, August 2023. | DOI: 10.1097/PRS.0000000000010198

  BACKGROUND

• Choi JB, Shim YH, Lee YW, Lee JS, Choi JR, Chang CH. Incidence and risk factors of postoperative nausea and vomiting in patients with fentanyl-based intravenous patient-controlled analgesia and single antiemetic prophylaxis. Yonsei Med J. 2014 Sep;55(5):1430-5. doi: 10.3349/ymj.2014.55.5.1430. PMID: 25048507; PMCID: PMC4108834.

  BACKGROUND

• Santosa KB, Lai YL, Brummett CM, Oliver JD, Hu HM, Englesbe MJ, Blair EM, Waljee JF. Higher Amounts of Opioids Filled After Surgery Increase Risk of Serious Falls and Fall-Related Injuries Among Older Adults. J Gen Intern Med. 2020 Oct;35(10):2917-2924. doi: 10.1007/s11606-020-06015-6. Epub 2020 Aug 3. PMID: 32748343; PMCID: PMC7572978.v

  BACKGROUND

MeSH Terms

Conditions

Gigantomastia

Study Officials

• Anthony Capito, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Dugom, MD

CONTACT

540-655-8133; pmdugom@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded in the study from which group they were randomized into. The postoperative care, surveys, and pain control regimen is standardized between the two groups. Blinding is maintained until patients complete their 1 week postoperative surveys.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be initially identified and introduced to the study in their preoperative breast reduction consultation in the office. Patients will be contacted via phone for the consenting process, which they will have a virtual copy of their consent, after their consultation. After completion of the consenting and enrollment process, they will be entered into REDCap and the software will automatically randomize participants into a control group (MMPC including narcotics) and an experimental group (PECs II block, MMPC no narcotics). In the experimental group, patients are informed that additional pain control is not withheld and that a paper prescription for a narcotic will be provided. Patients will be informed to use this paper prescription in the event their pain is not adequately controlled in the experimental group. Patients in the control group will have a paper prescription for a narcotic as well to maintain the study's blindness.

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)