ESP Blocks in Breast Free Flaps

NCT07891039 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IRB-24-1827
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective randomized controlled trial to assess the efficacy of erector spinae plane (ESP) blocks in patients undergoing autologous free flap breast reconstruction. Currently, patients undergoing this procedure remain in the hospital initially for flap monitoring until discharge criteria is met, when pain is adequately controlled and patient is able to ambulate independently. Prolonged hospital stays can occur due to persistent pain, typically abdominal pain as breasts are insensate following mastectomy. Persistent pain at abdominal incision can increase opioid requirements, impede ambulation trials, and delay discharge. This study aims to utilize ESP blocks to help augment pain control in patients undergoing autologous free flap breast reconstruction. The ESP block is a safe regional block that is already commonly utilized by multiple surgical specialties, such as general surgery, obstetrics and gynecology, cardiothoracic surgery, neurosurgery, and orthopedic surgery. The ESP block is an ultrasound-guided regional anesthesia technique where a local anesthetic is injected into the fascial plane between the erector spinae muscles and the thoracic vertebrae's transverse processes. This injection spreads longitudinally, blocking the spinal nerves and providing multi-dermatomal pain relief to the anterior, posterior, and lateral chest and abdominal walls, making it useful for surgeries and managing chronic pain. Patients in this study will be randomized into one of two groups, ESP block or No ESP (NESP) block group. The investigators will not be blinding patients to their study arm assignment, as this would require injecting placebo which the investigators believe would be an unnecessary risk to patient. Additionally, it was determined that it would not be feasible to blind patients as the ESP block participants would be numb in their abdomen and patients would immediately know whether or not they received the block. Participants will be informed of their study arm assignment on the day of surgery prior to proceeding to the operating room. Patients will then be asked to fill out a twice daily survey on pain and ambulation trials. Inpatient data on pain medication administration and time to discharge will be collected through chart review. This study aims to investigate the efficacy of ESP blocks to improve management of pain at abdominal incision, decrease inpatient opioid consumption, decrease time to ambulation, and decrease length of stay.

Conditions

Breast Reconstruction; Free Flap Reconstruction

Keywords

ESP Block

Outcome Measures

Primary Outcomes (1)

• Inpatient pain control

  Total MME while inpatient

  3-7 days

Secondary Outcomes (3)

• Subjective Pain Level

  3-7 days

• Ambulation

  3-7 days

• Length of Stay

  3-7 days

Study Arms (2)

ESP Block

EXPERIMENTAL

Patients will receive ESP block, as well as standard of care/pain medications

Drug: Bupivacaine with Epinephrine and Dexamethasone

No Block

NO INTERVENTION

Patients will not receive ESP block, but only standard of care/pain medications

Interventions

Bupivacaine with Epinephrine and Dexamethasone DRUG

ESP block = 20ml 0.25% Bupivacaine w/ 5mcg/ml Epinephrine + 4mg Dexamethasone. Administered by qualified anesthesiologist under ultrasound guidance.

ESP Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of breast cancer
• Undergoing abdominally based autologous free flap breast reconstruction
• Age 18-75
• BMI \<40
• Must be able to consent for themself

You may not qualify if:

• Weight \<50 kg
• Pre-existing opioid dependence
• Infection at site of ESP block injection
• Allergy to local anesthetic
• Coagulopathy disorder
• Pregnant
• Significant liver impairment (Child-Pugh class 3)

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

RECRUITING

Related Publications (5)

• Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.

  PMID: 30292068 BACKGROUND

• Pai B H P, Lai YH. Feasibility and Efficacy of Low Thoracic Ultrasound-Guided Erector Spinae Plane Blocks in Patients Undergoing Radical Total Mastectomy With Deep Inferior Epigastric Perforator Flap Reconstruction. Ann Plast Surg. 2022 Dec 1;89(6):656-659. doi: 10.1097/SAP.0000000000003290. Epub 2022 Oct 17.

  PMID: 36416694 BACKGROUND

• Park S, Park J, Choi JW, Bang YJ, Oh EJ, Park J, Hong KY, Sim WS. The efficacy of ultrasound-guided erector spinae plane block after mastectomy and immediate breast reconstruction with a tissue expander: a randomized clinical trial. Korean J Pain. 2021 Jan 1;34(1):106-113. doi: 10.3344/kjp.2021.34.1.106.

  PMID: 33380573 BACKGROUND

• ElHawary H, Abdelhamid K, Meng F, Janis JE. Erector Spinae Plane Block Decreases Pain and Opioid Consumption in Breast Surgery: Systematic Review. Plast Reconstr Surg Glob Open. 2019 Nov 20;7(11):e2525. doi: 10.1097/GOX.0000000000002525. eCollection 2019 Nov.

  PMID: 31942313 BACKGROUND

• Araya S, Webster TK, Egleston B, Amadio GM, Panichella JC, Elmer NA, Patel SA. Significant Reduction in Length of Stay in Deep Inferior Epigastric Perforator Flap Breast Reconstruction With Implementation of Multimodal ERAS Protocol. Ann Plast Surg. 2023 Jul 1;91(1):90-95. doi: 10.1097/SAP.0000000000003578.

  PMID: 37450866 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Epinephrine; Dexamethasone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Joowon Choi, MD

CONTACT

540-682-6695; jmchoi@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Lymphatic and Microsurgical Reconstruction

Model Details: All patients are undergoing autologous abdominally based free flap breast reconstruction. There are 2 arms of the study. Group 1 will receive the ESP block. Group 2 will not receive the ESP block. Rest of care (surgery and post op pain control) are the same for both groups.

Study Record Dates

• First Submitted: October 12, 2026
• First Posted: October 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)