Recruiting
Phase 1

ESP Blocks

Sponsor:

Carilion Clinic

Code:

NCT07891039

Conditions

Breast Reconstruction

Free Flap Reconstruction

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine with Epinephrine and Dexamethasone

Study Details

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

Study ID

NCT07891039

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ESP Block

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

no intervention: No Block

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

Interventions

Bupivacaine with Epinephrine and Dexamethasone

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

Primary outcome measure

  • Inpatient pain control [ Time Frame: 3-7 days ]

Central Contacts and Locations

Central contacts

Locations

Roanoke Memorial Hospital

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

More Information

Sponsor

Carilion Clinic

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • ESP Block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.