Postoperative PainPhase 4NCT04777591
Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction
A Phase 4 study testing Liposomal bupivacaine TAP block and Bupivacain in people with Postoperative Pain and Breast Reconstruction, run by University of Virginia at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain, Breast Reconstruction
- What is being tested?
- Liposomal bupivacaine TAP block and Bupivacain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2021to 28 Dec 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia Medical Center
Charlottesville, Virginia, 22902
University of Virginia
Charlottesville, Virginia, 22903
About this study
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.
- Conditions
- Postoperative Pain, Breast Reconstruction
- Being tested
- Liposomal bupivacaine TAP block, Bupivacain
- Keywords
- TAP block, Regional block, ERAS, liposomal bupivacaine, free flap
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaine TAP blockDrug
Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
BupivacainDrug
Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
| Study group | Role | What they receive |
|---|---|---|
| Control - plain bupivacaine | Active comparator | Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively Receives: Drug: Bupivacain |
| Experimental - Liposomal bupivacaine | Experimental | Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively Receives: Drug: Liposomal bupivacaine TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-op Pain Scores During Initial Hospitalization
Visual analog pain scale. Scores range from 0 to 10, 0 being no pain and 10 being worse pain that one experienced in their lifetime.
Measured: During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
Post-op Narcotic Pain Medication Use During Hospitalization
total amount of morphine milliequivalent
Measured: during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
Secondary outcomes (1)
Length of Hospital Stay
hospital length of stay
Measured: during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Mar 2021
- Primary completion28 Dec 2022
- Study completion28 Dec 2022
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 Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Model description
- Control group: TAP block with plain bupivacaine Intervention group: TAP block with plain bupivacaine + liposomal bupivacaine
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Stranix, University of Virginia
- Investigators
- John Stranix, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777591
- Sponsor's protocol ID
- HSR210033
- Status last verified
- Aug 2024
- First submitted
- 23 Feb 2021
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park RH, Chou J, DeVito RG, Elmer A, Hollenbeck ST, Campbell CA, Stranix JT. Effectiveness of Liposomal Bupivacaine Transversus Abdominis Plane Block in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial. Plast Reconstr Surg. 2024 Oct 1;154(4S):52S-59S. doi: 10.1097/PRS.0000000000011326. Epub 2024 Sep 20.
PubMed 38315156
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction
- ClinicalTrials.gov ID
- NCT04777591
- Acronym / sponsor ID
- HSR210033
- Conditions
- Postoperative Pain, Breast Reconstruction
- Keywords
- TAP block, Regional block, ERAS, liposomal bupivacaine, free flap
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Control group: TAP block with plain bupivacaine Intervention group: TAP block with plain bupivacaine + liposomal bupivacaine
| Arm | Type | Receives |
|---|---|---|
| Control - plain bupivacaine | Active comparator | Drug: BupivacainReceives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively |
| Experimental - Liposomal bupivacaine | Experimental | Drug: Liposomal bupivacaine TAP blockReceives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- Subjects with ages <18 years
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 bupivacaine TAP blockGroup will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control. | Drug | Experimental - Liposomal bupivacaine |
| BupivacainGroup will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control. | Drug | Control - plain bupivacaine |
Primary outcome
Post-op Pain Scores During Initial Hospitalization
Time frame: During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
Visual analog pain scale. Scores range from 0 to 10, 0 being no pain and 10 being worse pain that one experienced in their lifetime.
Post-op Narcotic Pain Medication Use During Hospitalization
Time frame: during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
total amount of morphine milliequivalent
1 secondary outcome
Length of Hospital Stay
Time frame: during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38315156Park RH, Chou J, DeVito RG, Elmer A, Hollenbeck ST, Campbell CA, Stranix JT. Effectiveness of Liposomal Bupivacaine Transversus Abdominis Plane Block in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial. Plast Reconstr Surg. 2024 Oct 1;154(4S):52S-59S. doi: 10.1097/PRS.0000000000011326. Epub 2024 Sep 20.
- Individual participant dataSharing planned: No
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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.
John Stranix, MD principal investigator
University of Virginia
2 sites 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 TAP block and Bupivacain in people with Postoperative Pain and Breast Reconstruction, run by University of Virginia at 2 sites 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 1 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 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 23 Aug 2024). 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?
Post-op Pain Scores During Initial Hospitalization (time frame: During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first). The study lists 2 primary outcomes in all. 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 NCT04777591, 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 23 Aug 2024.