Breast ReconstructionPhase 1NCT07891039
ESP Blocks in Breast Free Flaps
A Phase 1 study testing Bupivacaine with Epinephrine and Dexamethasone in people with Breast Reconstruction and Free Flap Reconstruction, run by Carilion Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Reconstruction, Free Flap Reconstruction
- What is being tested?
- Bupivacaine with Epinephrine and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Jun 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of breast cancer
- Undergoing abdominally based autologous free flap breast reconstruction
- Age 18-75
- BMI <40
- Must be able to consent for themself
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roanoke Memorial Hospital
Roanoke, Virginia, 24014
Joowon Choi, MD, 540-682-6695, jmchoi@carilionclinic.org
About this study
Official title: Efficacy of Erector Spinae Plane (ESP) Blocks in Free Flap-Based Breast Reconstruction: A Randomized Controlled Study
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
- Being tested
- Bupivacaine with Epinephrine and Dexamethasone
- Keywords
- ESP Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine with Epinephrine and DexamethasoneDrug
ESP block = 20ml 0.25% Bupivacaine w/ 5mcg/ml Epinephrine + 4mg Dexamethasone. Administered by qualified anesthesiologist under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| ESP Block | Experimental | Patients will receive ESP block, as well as standard of care/pain medications Receives: Drug: Bupivacaine with Epinephrine and Dexamethasone |
| No Block | No intervention | Patients will not receive ESP block, but only standard of care/pain medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatient pain control
Total MME while inpatient
Measured: 3-7 days
Secondary outcomes (3)
Subjective Pain Level
Patient reported pain score on scale of 1-10. Surveys administered twice daily (AM/PM) while inpatient.
Measured: 3-7 days
Ambulation
Patient reported ambulation. Also obtained from patient survey administered twice daily (AM/PM).
Measured: 3-7 days
Length of Stay
Total days of admission after surgery.
Measured: 3-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Oct 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Joy MD, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891039
- Sponsor's protocol ID
- IRB-24-1827
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers due to concerns regarding participant confidentiality and data privacy, as well as limitations related to the study's data-sharing infrastructure and resources. Study findings will be disseminated through peer-reviewed publications and other appropriate scientific communications.
Publications
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.
PubMed 30292068Pai 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.
PubMed 36416694Park 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.
PubMed 33380573ElHawary 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.
PubMed 31942313Araya 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.
PubMed 37450866