Clinical trial NCT04777591: Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction
Official title: Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Breast Reconstruction
Keywords: TAP block
Regional block
ERAS
liposomal bupivacaine
free flap
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group: TAP block with plain bupivacaine Intervention group: TAP block with plain bupivacaine + liposomal bupivacaine
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Post-op Pain Scores During Initial Hospitalization
timeFrame: During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
measure: Post-op Narcotic Pain Medication Use During Hospitalization
timeFrame: during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: John Stranix, MD
role: PRINCIPAL_INVESTIGATOR
References: