A Phase 1 interventional study of Bupivacaine with Epinephrine and Dexamethasone in Breast Reconstruction and Free Flap Reconstruction, sponsored by Carilion Clinic. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Carilion Clinic · Phase 1, Interventional, and Treatment
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.
Carilion Clinic is the lead sponsor of 75 studies on the registry; 14 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 2 (22%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will receive ESP block, as well as standard of care/pain medications
Drug: Bupivacaine with Epinephrine and Dexamethasone
Patients will not receive ESP block, but only standard of care/pain medications
Drug pages: Bupivacaine · Epinephrine · Dexamethasone
ESP block = 20ml 0.25% Bupivacaine w/ 5mcg/ml Epinephrine + 4mg Dexamethasone. Administered by qualified anesthesiologist under ultrasound guidance.
Inpatient pain control
Total MME while inpatient
Time frame: 3-7 days
Subjective Pain Level
Patient reported pain score on scale of 1-10. Surveys administered twice daily (AM/PM) while inpatient.
Time frame: 3-7 days
Ambulation
Patient reported ambulation. Also obtained from patient survey administered twice daily (AM/PM).
Time frame: 3-7 days
Length of Stay
Total days of admission after surgery.
Time frame: 3-7 days
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Bupivacaine · Epinephrine · Dexamethasone
Carilion Clinic