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NCT07891039
ESP Blocks in Breast Free Flaps
Conditions: Breast Reconstruction, Free Flap Reconstruction
Sex: Female
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 60
Sponsor: Carilion Clinic
Location: Roanoke Memorial Hospital Roanoke Virginia
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.
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of breast cancer
* Undergoing abdominally based autologous free flap breast reconstruction
* Age 18-75
* BMI \
Source: ClinicalTrials.gov (NCT07891039). StuddyBuddy aggregates publicly available trial information.