Breast ReconstructionPhase 4NCT03700970
Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction
A Phase 4 study testing Liposomal bupivacaine and Regular bupivacaine in people with Breast Reconstruction and Anesthesia, run by Vanderbilt University Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breast Reconstruction, Anesthesia, Transverse Abdominis Plane Block
- What is being tested?
- Liposomal bupivacaine and Regular bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2019to 30 Mar 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18-85 years
- males or females
- plastic surgery for abdominally-based free flap breast reconstruction.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
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
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.
Read the 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).
- Being tested
- Liposomal bupivacaine, Regular bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called LB
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 bupivacaineDrug
Also called Bupivacaine HCl
20mL of 0.25% bupivacaine injected on each side.
| Study group | Role | What they receive |
|---|---|---|
| TAP block with liposomal bupivacaine | Experimental | 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. Receives: Drug: Liposomal bupivacaine |
| TAP block with regular bupivacaine | Active comparator | 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. Receives: Drug: Regular bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Postoperative day (POD) 1 to 7
Secondary outcomes (10)
Pain Measure
Pain as measured by numeric rating scale ranging from 0 (no pain) to 10 (worst pain ever).
Measured: Post operative day (POD) 1 to 7
Time to First Opiate Use
Time from end of surgery to time of first opioid intake measured in hours
Measured: 0-29.8 hours post operation
Time to Return of Bowel Function
Mean time in days at which patients had a return of bowel movement post op
Measured: 1 to 4 days post operation
Length of Stay
Length of hospital stay post operatively
Measured: 1 to 4 days
Ambulation
Time to first ambulate post op (in days)
Measured: 1 day post op
Non-narcotic Pain Medication Intake: Acetaminophen
The total use of the non-narcotic pain medication Acetaminophen was recorded during hospitalization
Measured: Post op day 1 to 7
Non Narcotic Pain Medication Intake: Cyclobenzaprine
The total use of the non-narcotic pain medication Cyclobenzaprine was recorded during hospitalization
Measured: Post op day 1 to 7
Non Narcotic Pain Medication Intake: Gabapentin
The total use of the non-narcotic pain medication gabapentin was recorded during hospitalization
Measured: Post op day 1 to 7
Non Narcotic Pain Medication Intake: Celebrex
The total use of the non-narcotic pain medication celebrex was recorded during hospitalization
Measured: post op day 1 to 7
Non Narcotic Pain Medication Intake: Ondansetron
The total use of the non-narcotic pain medication ondansetron was recorded during hospitalization
Measured: Post op day 1 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start13 Jun 2019
- Primary completion15 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galen Perdikis, Vanderbilt University Medical Center
- Investigators
- Galen Perdikis, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700970
- Sponsor's protocol ID
- 180421
- Status last verified
- Dec 2021
- First submitted
- 2 Oct 2018
- Last updated
- 24 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen L, Glassman GE, Afshari A, Feng X, Shastri UD, Kaoutzanis C, McEvoy MD, Bansal V, Canlas C, Yao J, Higdon K, Perdikis G. Randomized Controlled Trial Comparing Liposomal to Plain Bupivacaine in the Transversus Abdominis Plane for DIEP Flap Breast Reconstruction. Plast Reconstr Surg. 2024 Mar 1;153(3):543-551. doi: 10.1097/PRS.0000000000010710. Epub 2023 May 22.
PubMed 37220228
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03700970
- Acronym / sponsor ID
- 180421
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Posted 24 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block with liposomal bupivacaine | Experimental | Drug: Liposomal bupivacaineLocal 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. |
| TAP block with regular bupivacaine | Active comparator | Drug: Regular bupivacaineLocal 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 18-85 years
- males or females
- plastic surgery for abdominally-based free flap breast reconstruction.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaineAlso: LB20mL 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 | TAP block with liposomal bupivacaine |
| Regular bupivacaineAlso: Bupivacaine HCl20mL of 0.25% bupivacaine injected on each side. | Drug | TAP block with regular bupivacaine |
Primary outcome
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
10 secondary outcomes
Pain Measure
Time frame: Post operative day (POD) 1 to 7
Time to First Opiate Use
Time frame: 0-29.8 hours post operation
Time to Return of Bowel Function
Time frame: 1 to 4 days post operation
Length of Stay
Time frame: 1 to 4 days
Ambulation
Time frame: 1 day post op
Non-narcotic Pain Medication Intake: Acetaminophen
Time frame: Post op day 1 to 7
Non Narcotic Pain Medication Intake: Cyclobenzaprine
Time frame: Post op day 1 to 7
Non Narcotic Pain Medication Intake: Gabapentin
Time frame: Post op day 1 to 7
Non Narcotic Pain Medication Intake: Celebrex
Time frame: post op day 1 to 7
Non Narcotic Pain Medication Intake: Ondansetron
Time frame: Post op day 1 to 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37220228Nguyen L, Glassman GE, Afshari A, Feng X, Shastri UD, Kaoutzanis C, McEvoy MD, Bansal V, Canlas C, Yao J, Higdon K, Perdikis G. Randomized Controlled Trial Comparing Liposomal to Plain Bupivacaine in the Transversus Abdominis Plane for DIEP Flap Breast Reconstruction. Plast Reconstr Surg. 2024 Mar 1;153(3):543-551. doi: 10.1097/PRS.0000000000010710. Epub 2023 May 22.
- Individual participant dataSharing planned: No
Related trials for Breast Reconstruction
Active, not recruitingObservational study
Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
Breast Augmentation, Breast Reconstruction
Not yet recruiting
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
Breast Cancer
Recruiting
Comparison of Mastectomy Expander Trial
Mastectomy and Breast Reconstruction, Tissue Expander Based Breast Reconstruction
RecruitingPhase 1
ESP Blocks in Breast Free Flaps
Breast Reconstruction, Free Flap Reconstruction
Active, not recruitingObservational study
Autologous Nerve Graft Breast Reconstruction Neurotization
Breast Reconstruction, Breast Cancer Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galen Perdikis, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal bupivacaine and Regular bupivacaine in people with Breast Reconstruction and Anesthesia, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME) (time frame: Postoperative day (POD) 1 to 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03700970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.