Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03700970
Recruitment Status : Completed
First Posted : October 9, 2018
Results First Posted : January 24, 2022
Last Update Posted : January 24, 2022
Sponsor:
Information provided by (Responsible Party):
Galen Perdikis, Vanderbilt University Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Breast Reconstruction Anesthesia Transverse Abdominis Plane Block Drug: Liposomal bupivacaine Drug: Regular bupivacaine Phase 4

Detailed 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).
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Participants and plastic surgeons will be blinded to the study treatment arm
Primary Purpose: Treatment
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
Actual Study Start Date : June 13, 2019
Actual Primary Completion Date : March 15, 2021
Actual Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: TAP block with liposomal bupivacaine
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 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.
 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.
Other Name: LB
Active Comparator: TAP block with regular bupivacaine
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
 Drug: Regular bupivacaine
20mL of 0.25% bupivacaine injected on each side.
Other Name: Bupivacaine HCl


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700970


Locations
Layout table for location information
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Galen Perdikis, MD Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Galen Perdikis, Vanderbilt University Medical Center:
Study Protocol  [PDF] October 1, 2018
Statistical Analysis Plan  [PDF] October 1, 2018
Informed Consent Form  [PDF] July 18, 2019

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Galen Perdikis, Chair and Professor of Surgery Department of Plastic Surgery, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03700970    
Other Study ID Numbers: 180421
First Posted: October 9, 2018    Key Record Dates
Results First Posted: January 24, 2022
Last Update Posted: January 24, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents