PainNCT06091241
ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery
A study testing Pre-operative Erector Spinae Plane block prior to DIEP surgery and Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery in people with Pain, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Breast cancer is the second most common cancer diagnosed in American women . For patients who have undergone surgical mastectomy, autologous breast reconstruction is an alternative option to breast implants. Deep Inferior Epigastric Perforator (DIEP) flaps are the gold standard for autologous breast reconstruction . Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- Pre-operative Erector Spinae Plane block prior to DIEP surgery and Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women with breast cancer, ASA 1-3, undergoing DIEP flap surgery
Who cannot join
- Chronic opioid use contraindications to local anesthetics or regional analgesia Inability to communicate intensity of pain on a numeric analog scale
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Rachel Henning, 9139458072, rhenning2@kumc.edu
Tara Notarianni, DO
About this study
Breast cancer is the second most common cancer diagnosed in American women . For patients who have undergone surgical mastectomy, autologous breast reconstruction is an alternative option to breast implants. Deep Inferior Epigastric Perforator (DIEP) flaps are the gold standard for autologous breast reconstruction . Effective pain control following surgery is imperative and ultrasound-guided bilateral transversus abdominis plane blocks (TAPs) with the infiltration of local anesthetics, such a ropivacaine are a common regional technique of choice . A newer described technique, bilateral Erector Spinae Plane blocks (ESPBs) (which also are an infiltration of local anesthetic) present as an alternative approach for post-operative analgesia. ESPBs have been proven efficacious in reducing intra- and post-operative opioid requirements, lessening the need for rescue analgesics in other similar surgical procedures.
The hypothesis is that preoperative bilateral ESPBs could provide equivalent pain control as a regional analgesic for patients undergoing DIEP flap surgery when compared to preoperative bilateral TAPs
- Conditions
- Pain
- Being tested
- Pre-operative Erector Spinae Plane block prior to DIEP surgery, Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative Erector Spinae Plane block prior to DIEP surgeryProcedure or surgery
Also called ESPBs
After obtaining informed consent to participate in the study, patients will be randomized by a computer 50/50 to either the Erector Spinae Plane group or the Transversus Abdominus Plane group at the time of their surgical clinic visit prior to their scheduled surgery. Then on the morning of surgery, the Erector Spinae Plane group will receive a bilateral ultrasound-guided Erector Spinae Plane peripheral nerve block. During this intervention, 0.25% ropivacaine will be injected below the fascia of the erector spinae muscle group.
Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgeryProcedure or surgery
Also called TAPs
On the morning of surgery, the patients in the TAPs group will receive a bilateral ultrasound-guided Transversus Abdominus plane peripheral nerve block. During this intervention, 0.25% ropivacaine will be injected into the transversus abdominus plane above the transversus abdominus muscle.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Erector Spinae Plane blocks | Other | Erector Spinae Plane blocks Receives: Procedure: Pre-operative Erector Spinae Plane block prior to DIEP surgery |
| Group 2: Transversus Abdominis Plane blocks | Other | Transversus Abdominis Plane blocks Receives: Procedure: Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')
Measured: 24 hours post injection
Mean Morphine Equivalents
Amount of opioid pain medications administered and converted to morphine equivalents
Measured: 24 hours post injection
Secondary outcomes (7)
Numerical Rating Scale
Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')
Measured: 12 hours post injection
Michigan Body Map
Map used to show body location of worst site of primary pain
Measured: 24 hours post injection
Mean Morphine Equivalents
Amount of opioid pain medications administered and converted to morphine equivalents
Measured: 48 hours post injection
Numerical Rating Scale
Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')
Measured: 48 hours post injection
Numerical Rating Scale
Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')
Measured: 1 week post-operation
Numerical Rating Scale
Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')
Measured: 2 weeks post-operation
Numerical Rating Scale
Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')
Measured: 6 weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Nov 2023
- Primary completion15 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Kansas 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tara Notarianni, DO, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091241
- Sponsor's protocol ID
- STUDY00150240
- Status last verified
- May 2026
- First submitted
- 3 Jul 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery
- ClinicalTrials.gov ID
- NCT06091241
- Acronym / sponsor ID
- STUDY00150240
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Oct 2023 (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.
Breast cancer is the second most common cancer diagnosed in American women . For patients who have undergone surgical mastectomy, autologous breast reconstruction is an alternative option to breast implants. Deep Inferior Epigastric Perforator (DIEP) flaps are the gold standard for autologous breast reconstruction . Effective pain control following surgery is imperative and ultrasound-guided bilateral transversus abdominis plane blocks (TAPs) with the infiltration of local anesthetics, such a ropivacaine are a common regional technique of choice . A newer described technique, bilateral Erector Spinae Plane blocks (ESPBs) (which also are an infiltration of local anesthetic) present as an alternative approach for post-operative analgesia. ESPBs have been proven efficacious in reducing intra- and post-operative opioid requirements, lessening the need for rescue analgesics in other similar surgical procedures.
The hypothesis is that preoperative bilateral ESPBs could provide equivalent pain control as a regional analgesic for patients undergoing DIEP flap surgery when compared to preoperative bilateral TAPs
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Erector Spinae Plane blocks | Other | Procedure: Pre-operative Erector Spinae Plane block prior to DIEP surgeryErector Spinae Plane blocks |
| Group 2: Transversus Abdominis Plane blocks | Other | Procedure: Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgeryTransversus Abdominis Plane blocks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult women with breast cancer, ASA 1-3, undergoing DIEP flap surgery
Key exclusion criteria (1 listed)
- Chronic opioid use contraindications to local anesthetics or regional analgesia Inability to communicate intensity of pain on a numeric analog scale
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 |
|---|---|---|
| Pre-operative Erector Spinae Plane block prior to DIEP surgeryAlso: ESPBsAfter obtaining informed consent to participate in the study, patients will be randomized by a computer 50/50 to either the Erector Spinae Plane group or the Transversus Abdominus Plane group at the time of their surgical clinic visit prior to their scheduled surgery. Then on the morning of surgery, the Erector Spinae Plane group will receive a bilateral ultrasound-guided Erector Spinae Plane peripheral nerve block. During this intervention, 0.25% ropivacaine will be injected below the fascia of the erector spinae muscle group. | Procedure or surgery | Group 1: Erector Spinae Plane blocks |
| Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgeryAlso: TAPsOn the morning of surgery, the patients in the TAPs group will receive a bilateral ultrasound-guided Transversus Abdominus plane peripheral nerve block. During this intervention, 0.25% ropivacaine will be injected into the transversus abdominus plane above the transversus abdominus muscle. | Procedure or surgery | Group 2: Transversus Abdominis Plane blocks |
Primary outcome
Numerical Rating Scale
Time frame: 24 hours post injection
Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')
Mean Morphine Equivalents
Time frame: 24 hours post injection
Amount of opioid pain medications administered and converted to morphine equivalents
7 secondary outcomes
Numerical Rating Scale
Time frame: 12 hours post injection
Michigan Body Map
Time frame: 24 hours post injection
Mean Morphine Equivalents
Time frame: 48 hours post injection
Numerical Rating Scale
Time frame: 48 hours post injection
Numerical Rating Scale
Time frame: 1 week post-operation
Numerical Rating Scale
Time frame: 2 weeks post-operation
Numerical Rating Scale
Time frame: 6 weeks post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-operative Erector Spinae Plane block prior to DIEP surgery and Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery in people with Pain, run by University of Kansas 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Keller (9139458072, rkeller@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (time frame: 24 hours post injection). 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 4 Jun 2026.