Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction

Anesthesia Clinical Trial

Official title:

Double-Blinded Randomized Control Trial Comparing Liposomal Bupivacaine and Bupivacaine Hydrochloride in Transversus Abdominis Plane Blocks Prior To DIEP Flap for Breast Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700970
• Other study ID #: 180421
• Status: Completed
• Phase: Phase 4
• Start date: June 13, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: December 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients undergoing abdominally-based free flap breast reconstruction at Vanderbilt University Medical Center.

Description:

Transversus Abdominis Plane (TAP) blocks are commonly used as part of Enhanced Recovery After Surgery (ERAS) pathway. This prospective, double-blinded, randomized control trial compares post-operative pain and narcotic consumption after deep inferior epigastric artery perforator (DIEP) breast reconstruction with liposomal bupivacaine (LB) compared to bupivacaine hydrochloride (BHCl). Subjects undergoing DIEP flaps were randomly assigned LB or BHCl, performed using ultrasound-guided TAP block technique pre-procedurally. Primary outcomes were postoperative narcotic analgesia required in oral morphine equivalents (OME) from postoperative day (POD) 0 to 7. Secondary outcomes included POD 1-7 pain Numeric Rating Scale (NRS), non-narcotic pain medication consumption, time to first narcotic use, return of bowel function, and length of stay (LOS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 30, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. age between 18-85 years

2. males or females

3. plastic surgery for abdominally-based free flap breast reconstruction.

Exclusion Criteria:

1. those not candidates for TAP blocks due to allergies to the medications (e.g., bupivacaine)

2. those with anatomic contra-indications to performing a TAP block

3. those unwilling to participate in follow-up assessments

4. vulnerable populations

5. chronic pain or associated diagnosis

Related Conditions & MeSH terms

• Anesthesia
• Breast Reconstruction
• Transverse Abdominis Plane Block

Intervention

Drug:
• Liposomal bupivacaine
20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
• Regular bupivacaine
20mL of 0.25% bupivacaine injected on each side.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)	Amount of supplemental postoperative narcotic analgesia (both intravenous and oral) required by study groups in oral morphine equivalents	Postoperative day (POD) 1 to 7
Secondary	Pain Measure	Pain as measured by numeric rating scale ranging from 0 (no pain) to 10 (worst pain ever).	Post operative day (POD) 1 to 7
Secondary	Time to First Opiate Use	Time from end of surgery to time of first opioid intake measured in hours	0-29.8 hours post operation
Secondary	Time to Return of Bowel Function	Mean time in days at which patients had a return of bowel movement post op	1 to 4 days post operation
Secondary	Length of Stay	Length of hospital stay post operatively	1 to 4 days
Secondary	Ambulation	Time to first ambulate post op (in days)	1 day post op
Secondary	Non-narcotic Pain Medication Intake: Acetaminophen	The total use of the non-narcotic pain medication Acetaminophen was recorded during hospitalization	Post op day 1 to 7
Secondary	Non Narcotic Pain Medication Intake: Cyclobenzaprine	The total use of the non-narcotic pain medication Cyclobenzaprine was recorded during hospitalization	Post op day 1 to 7
Secondary	Non Narcotic Pain Medication Intake: Gabapentin	The total use of the non-narcotic pain medication gabapentin was recorded during hospitalization	Post op day 1 to 7
Secondary	Non Narcotic Pain Medication Intake: Celebrex	The total use of the non-narcotic pain medication celebrex was recorded during hospitalization	post op day 1 to 7
Secondary	Non Narcotic Pain Medication Intake: Ondansetron	The total use of the non-narcotic pain medication ondansetron was recorded during hospitalization	Post op day 1 to 7