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Completed

NCT Number: NCT03700970

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

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.

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Key information

Conditions

Breast Reconstruction Anesthesia Transverse Abdominis Plane Block

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 18-85 years
  • males or females
  • plastic surgery for abdominally-based free flap breast reconstruction.

Exclusion criteria

  • those not candidates for TAP blocks due to allergies to the medications (e.g., bupivacaine)
  • those with anatomic contra-indications to performing a TAP block
  • those unwilling to participate in follow-up assessments
  • vulnerable populations
  • chronic pain or associated diagnosis

Treatment and study plan

Liposomal bupivacaine

Drug

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.

Other names: LB

Regular bupivacaine

Drug

20mL of 0.25% bupivacaine injected on each side.

Other names: Bupivacaine HCl

Primary outcomes

  1. Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)

    Time frame: Postoperative day (POD) 1 to 7

    Amount of supplemental postoperative narcotic analgesia (both intravenous and oral) required by study groups in oral morphine equivalents

Secondary outcomes

  1. Pain Measure

    Time frame: Post operative day (POD) 1 to 7

    Pain as measured by numeric rating scale ranging from 0 (no pain) to 10 (worst pain ever).

  2. Time to First Opiate Use

    Time frame: 0-29.8 hours post operation

    Time from end of surgery to time of first opioid intake measured in hours

  3. Time to Return of Bowel Function

    Time frame: 1 to 4 days post operation

    Mean time in days at which patients had a return of bowel movement post op

  4. Length of Stay

    Time frame: 1 to 4 days

    Length of hospital stay post operatively

  5. Ambulation

    Time frame: 1 day post op

    Time to first ambulate post op (in days)

  6. Non-narcotic Pain Medication Intake: Acetaminophen

    Time frame: Post op day 1 to 7

    The total use of the non-narcotic pain medication Acetaminophen was recorded during hospitalization

  7. Non Narcotic Pain Medication Intake: Cyclobenzaprine

    Time frame: Post op day 1 to 7

    The total use of the non-narcotic pain medication Cyclobenzaprine was recorded during hospitalization

  8. Non Narcotic Pain Medication Intake: Gabapentin

    Time frame: Post op day 1 to 7

    The total use of the non-narcotic pain medication gabapentin was recorded during hospitalization

  9. Non Narcotic Pain Medication Intake: Celebrex

    Time frame: post op day 1 to 7

    The total use of the non-narcotic pain medication celebrex was recorded during hospitalization

  10. Non Narcotic Pain Medication Intake: Ondansetron

    Time frame: Post op day 1 to 7

    The total use of the non-narcotic pain medication ondansetron was recorded during hospitalization

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2018
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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