Deep Inferior Epigastric Perforator Flap Breast ReconstructionNCT06962150
TAP vs QL Block for DIEP Flap Breast Reconstruction
A study testing Surgeon-placed transversus abdominis plane block and Ultrasound-guided quadratus lumborum block in people with Deep Inferior Epigastric Perforator Flap Breast Reconstruction, run by Yale University.
Trial summary
The purpose of this two-arm clinical study is to compare two nerve block techniques, the transversus abdominis plane (TAP) block and the quadratus lumborum (QL) block, in terms of how well they manage pain in the immediate postoperative period in patients undergoing deep inferior epigastric perforator flap breast… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Deep Inferior Epigastric Perforator Flap Breast Reconstruction
- What is being tested?
- Surgeon-placed transversus abdominis plane block and Ultrasound-guided quadratus lumborum block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Female ≥ 18 years of age at date of surgery
- Patient is booked for a DIEP flap breast reconstruction. Immediate and delayed reconstruction are both acceptable. Unilateral and bilateral reconstruction are both acceptable.
- English speaking or other with aid of in-person translator
Who cannot join
- Patient unwilling to participate in trial
- Patient has allergy to nerve block components
- Patient is currently taking opioids for any reason
About this study
Official title: Parallel Randomized Controlled Trial Study of Surgeon-Placed Transversus Abdominis Plane vs Ultrasound-Guided Quadratus Lumborum Blocks for Postoperative Analgesia Following Autologous Abdominal-Based Flap Breast Reconstruction
The purpose of this two-arm clinical study is to compare two nerve block techniques, the transversus abdominis plane (TAP) block and the quadratus lumborum (QL) block, in terms of how well they manage pain in the immediate postoperative period in patients undergoing deep inferior epigastric perforator flap breast reconstruction.
Read the detailed description
This study is a randomized trial with two parallel intervention arms comparing TAP and QL blocks for post-operative analgesia in patients undergoing deep inferior epigastric perforator (DIEP) flap breast reconstruction. Participants scheduled to undergo DIEP flap breast reconstruction will be prospectively recruited and randomly allocated to receive either a surgeon-placed TAP block intraoperatively or an anesthesiologist-placed, ultrasound-guided QL block preoperatively. The overall objective of this study is to provide evidence of a best-practice procedure for managing pain post-operatively.
Aim 1: To compare postoperative pain scores and total opioid consumption (in morphine milligram equivalents) in the first 48 hours postoperatively between the two study groups.
Hypothesis 1: Receipt of the QL block is associated with relatively lower postoperative pain scores and reduced total opioid consumption.
Aim 2: To describe any changes in operation duration, time spent in the PACU, length of stay, time to ambulation, and costs that may be associated with using the more efficacious nerve block (as determined by results related to the primary objective).
Hypothesis 2: The QL block will be associated with shorter time to ambulation, time spent in the PACU, and length of stay. Because of requirements for the QL block to be administered preoperatively solely under ultrasound guidance by an anesthesiologist, receipt of the QL block is associated with increased operation time and total procedural costs compared to receipt of the TAP block.
- Being tested
- Surgeon-placed transversus abdominis plane block, Ultrasound-guided quadratus lumborum block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgeon-placed transversus abdominis plane blockProcedure or surgery
Participants will receive a transversus abdominis plane (TAP) block intraoperatively, administered by the operating plastic surgeon. The drug components of the TAP block are 20 ml liposomal bupivacaine (Exparel) mixed with 20 ml 0.5% bupivacaine.
Ultrasound-guided quadratus lumborum blockProcedure or surgery
Participants will receive a quadratus lumborum (QL) block preoperatively, administered by the anesthesiologist under ultrasound guidance. The drug components of the QL block are 10 mg dexamethasone, 80 mg methylprednisolone acetate, plus either 0.25% or 0.5% bupivacaine at the dose of 0.25 mg/kg bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Active comparator | Participants will receive a transversus abdominis plane (TAP) block intraoperatively, administered by the operating plastic surgeon. The drug components of the TAP block are 20 ml liposomal bupivacaine (Exparel) mixed with 20 ml 0.5% bupivacaine. Receives: Procedure: Surgeon-placed transversus abdominis plane block |
| QL block | Experimental | Participants will receive a quadratus lumborum (QL) block preoperatively, administered by the anesthesiologist under ultrasound guidance. The drug components of the QL block are 10 mg dexamethasone, 80 mg methylprednisolone acetate, plus either 0.25% or 0.5% bupivacaine at the dose of 0.25 mg/kg bupivacaine. Receives: Procedure: Ultrasound-guided quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant self-reported pain score, as measured by the Visual Analogue Scale at postoperative hours 0, 2, 4, 6, 12, 24, 36, 48
Participants will be asked to self-report their pain using the Visual Analogue Scale (VAS) at postoperative hours 0, 2, 4, 6, 12, 24, 36, and 48. The minimum sore on the VAS is 0 (no pain) and the maximum score is 10 (worst pain).
Measured: Postoperative hour 0 to 48
Opioid consumption during the first 48 postoperative hours
Participants' opioid consumption (in morphine milligram equivalents) during the first 48 postoperative hours will be recorded. (or until pt is discharged?)
Measured: Postoperative hour 0 to 48
Secondary outcomes (5)
Operation duration
Operation duration is measured as the time from first incision to final closure. (?)
Measured: Intraoperative period
Time spent in the post-anesthesia care unit
Time spent in the post-anesthesia care unit (PACU) is measured as the time out of the operating room to completion of PACU care.
Measured: Postoperative - interval immediately following surgery
Length of hospital stay
Length of stay is measured as the time from when the patient leaves the operating room to patient discharge.
Measured: Postoperative - approximately 48 hours
Time to ambulation
Time to ambulation is defined as the time from when the patient leaves the operating room to first ambulation (which is?).
Measured: Postoperative hour 0 to 48
Costs associated with each intervention
We will consider personnel, medication, operation time, length of stay, and other intervention-specific costs to calculate total costs associated with each nerve block intervention.
Measured: Participant check-in to discharge, approximately 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study startDec 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Study not moving forward.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Inferior Epigastric Perforator Flap Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haripriya Ayyala, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962150
- Sponsor's protocol ID
- 2000035712
- Status last verified
- May 2025
- First submitted
- 12 Nov 2024
- Last updated
- 8 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Randomized Controlled Trial Study of Surgeon-Placed Transversus Abdominis Plane vs Ultrasound-Guided Quadratus Lumborum Blocks for Postoperative Analgesia Following Autologous Abdominal-Based Flap Breast Reconstruction
- ClinicalTrials.gov ID
- NCT06962150
- Acronym / sponsor ID
- 2000035712
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not moving forward.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this two-arm clinical study is to compare two nerve block techniques, the transversus abdominis plane (TAP) block and the quadratus lumborum (QL) block, in terms of how well they manage pain in the immediate postoperative period in patients undergoing deep inferior epigastric perforator flap breast reconstruction.
Detailed description
This study is a randomized trial with two parallel intervention arms comparing TAP and QL blocks for post-operative analgesia in patients undergoing deep inferior epigastric perforator (DIEP) flap breast reconstruction. Participants scheduled to undergo DIEP flap breast reconstruction will be prospectively recruited and randomly allocated to receive either a surgeon-placed TAP block intraoperatively or an anesthesiologist-placed, ultrasound-guided QL block preoperatively. The overall objective of this study is to provide evidence of a best-practice procedure for managing pain post-operatively.
Aim 1: To compare postoperative pain scores and total opioid consumption (in morphine milligram equivalents) in the first 48 hours postoperatively between the two study groups.
Hypothesis 1: Receipt of the QL block is associated with relatively lower postoperative pain scores and reduced total opioid consumption.
Aim 2: To describe any changes in operation duration, time spent in the PACU, length of stay, time to ambulation, and costs that may be associated with using the more efficacious nerve block (as determined by results related to the primary objective).
Hypothesis 2: The QL block will be associated with shorter time to ambulation, time spent in the PACU, and length of stay. Because of requirements for the QL block to be administered preoperatively solely under ultrasound guidance by an anesthesiologist, receipt of the QL block is associated with increased operation time and total procedural costs compared to receipt of the TAP block.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block | Active comparator | Procedure: Surgeon-placed transversus abdominis plane blockParticipants will receive a transversus abdominis plane (TAP) block intraoperatively, administered by the operating plastic surgeon. The drug components of the TAP block are 20 ml liposomal bupivacaine (Exparel) mixed with 20 ml 0.5% bupivacaine. |
| QL block | Experimental | Procedure: Ultrasound-guided quadratus lumborum blockParticipants will receive a quadratus lumborum (QL) block preoperatively, administered by the anesthesiologist under ultrasound guidance. The drug components of the QL block are 10 mg dexamethasone, 80 mg methylprednisolone acetate, plus either 0.25% or 0.5% bupivacaine at the dose of 0.25 mg/kg bupivacaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female ≥ 18 years of age at date of surgery
- Patient is booked for a DIEP flap breast reconstruction. Immediate and delayed reconstruction are both acceptable. Unilateral and bilateral reconstruction are both acceptable.
- English speaking or other with aid of in-person translator
Key exclusion criteria (3 listed)
- Patient unwilling to participate in trial
- Patient has allergy to nerve block components
- Patient is currently taking opioids for any reason
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 |
|---|---|---|
| Surgeon-placed transversus abdominis plane blockParticipants will receive a transversus abdominis plane (TAP) block intraoperatively, administered by the operating plastic surgeon. The drug components of the TAP block are 20 ml liposomal bupivacaine (Exparel) mixed with 20 ml 0.5% bupivacaine. | Procedure or surgery | TAP block |
| Ultrasound-guided quadratus lumborum blockParticipants will receive a quadratus lumborum (QL) block preoperatively, administered by the anesthesiologist under ultrasound guidance. The drug components of the QL block are 10 mg dexamethasone, 80 mg methylprednisolone acetate, plus either 0.25% or 0.5% bupivacaine at the dose of 0.25 mg/kg bupivacaine. | Procedure or surgery | QL block |
Primary outcome
Participant self-reported pain score, as measured by the Visual Analogue Scale at postoperative hours 0, 2, 4, 6, 12, 24, 36, 48
Time frame: Postoperative hour 0 to 48
Participants will be asked to self-report their pain using the Visual Analogue Scale (VAS) at postoperative hours 0, 2, 4, 6, 12, 24, 36, and 48. The minimum sore on the VAS is 0 (no pain) and the maximum score is 10 (worst pain).
Opioid consumption during the first 48 postoperative hours
Time frame: Postoperative hour 0 to 48
Participants' opioid consumption (in morphine milligram equivalents) during the first 48 postoperative hours will be recorded. (or until pt is discharged?)
5 secondary outcomes
Operation duration
Time frame: Intraoperative period
Time spent in the post-anesthesia care unit
Time frame: Postoperative - interval immediately following surgery
Length of hospital stay
Time frame: Postoperative - approximately 48 hours
Time to ambulation
Time frame: Postoperative hour 0 to 48
Costs associated with each intervention
Time frame: Participant check-in to discharge, approximately 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- 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.
Haripriya Ayyala, MD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A study testing Surgeon-placed transversus abdominis plane block and Ultrasound-guided quadratus lumborum block in people with Deep Inferior Epigastric Perforator Flap Breast Reconstruction, run by Yale University.
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 3 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: withdrawn, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Participant self-reported pain score, as measured by the Visual Analogue Scale at postoperative hours 0, 2, 4, 6, 12, 24, 36, 48 (time frame: Postoperative hour 0 to 48). 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?
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 8 May 2025.