NOT_YET_RECRUITING
Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction
Transversus Abdominis Plane (TAP) block is a useful tool in pain management after abdominal surgery. It is a regional nerve block that targets T6-L1 thoracolumbar nerves running in the plane between internal oblique and transversus abdominis muscle. It is shown to help with post-operative pain management, reducing pain scores and narcotic pain medication use, as well as promoting earlier return to activity and recovery. TAP block became a very popular, safe, and effective therapeutic adjunct for many different abdominal surgeries ranging from obstetric procedures to general surgery procedures like colorectal surgery. Furthermore, it is used in plastic surgery procedures such as Deep Inferior Epigastric Perforator (DIEP) free flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap, as they involve extensive amount of abdominal soft tissue incision. Previous studies have shown that TAP block in these procedures significantly reduce post-op pain and narcotic pain medication use. More recently, Exparel (liposomal bupivacaine) has risen to spotlight for providing a longer, sustained local anesthesia. Various surgical disciplines have adopted this agent as part of their pain management protocol. However, there are no literatures that describe the effect of TAP block using Exparel for breast free flap population. The study hypothesize that delivering TAP block with Exparel (vs. plain bupivacaine) will provide longer regional blocking effect, hence aiding in pain control and recovery postoperatively. The investigators will be analyzing postop narcotic pain medication requirement and pain scores to look into this question.
Conditions:
🦠 Postoperative Pain 🦠 Breast Reconstruction
🗓️ Study Start (Actual) 10 March 2021
🗓️ Primary Completion (Estimated) 28 February 2023
✅ Study Completion (Estimated) 28 February 2024
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Charlottesville, Virginia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center

    Exclusion Criteria:

    • * Subjects with ages \<18 years
    • * Allergy to local anesthetic
    • * Inability to tolerate standard postoperative pain management regimen (Tylenol, Toradol, and Oxycodone PRN) for any reason
    • * Subjects who cannot read or understand English
    • * Subjects who are pregnant
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 February 2021
  • First Submitted that Met QC Criteria 1 March 2021
  • First Posted 2 March 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 March 2021
  • Last Update Posted 2 March 2021
  • Last Verified March 2021