Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction

Postoperative Pain Clinical Trial

Official title:

Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04777591
• Other study ID #: HSR210033
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 10, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2021
• Source: University of Virginia
• Contact: Rachel H Park, MD
• Phone: 5714287278
• Email: rhp7gu[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Reconstruction
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Liposomal bupivacaine TAP block
Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
• Bupivacain
Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control.

Locations

Country	Name	City	State
United States	University of Virginia Medical Center	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-op pain scores during initial hospitalization	Visual analog pain scale (0-10)	During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
Primary	post-op narcotic pain medication use during hospitalization	total amount of morphine milliequivalent	during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
Primary	post-op narcotic pain medication use after discharge (within 30 days of discharge)	total amount of morphine milliequivalent	from the time of discharge to 30 days post discharge
Secondary	Length of hospital stay	hospital length of stay	during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
Secondary	Incidence of Post-op nausea and vomiting (PONV)	Incidence of PONV	during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first