Atrial Septal DefectPhase 4NCT05688670
Regional Anesthesia Following Pediatric Cardiac Surgery
A Phase 4 study testing Regional Anesthesia, Wound infiltration and Ropivacaine 0.2% Injectable Solution in people with Atrial Septal Defect and Ventricular Septal Defect, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Septal Defect, Ventricular Septal Defect, Pain, Procedural
- What is being tested?
- Regional Anesthesia, Wound infiltration and Ropivacaine 0.2% Injectable Solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 22 Jan 2025
- 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 Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children less than 18 years old
- Presenting for primary atrial septal defect or ventricular septal defect repair
- Informed consent / assent provided
Who cannot join
- Patients on opioid therapy at the time of surgery
- History of sternotomy
- Planned postoperative intubation
- Current diagnosis of a chronic pain syndrome.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Pain Control With Regional Anesthesia Following Pediatric Cardiac Surgery: A Randomized Double-Blinded Pilot Study
The purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.
Read the detailed description
This is a single center, randomized, double blind investigation which will compare postoperative pain control indices, functional recovery metrics and patient/parental satisfaction for pediatric patients receiving an ultrasound guided regional anesthetic versus surgeon delivered wound infiltration in children undergoing primary atrial and ventricular septal defect repairs. Surgical and anesthesia care, with the exception of the technique of local anesthetic administration, are not altered for study purposes. Subjects are randomized 1:1 to either bilateral Pecto-Intercostal Fascial Block and unilateral Rectus Sheath Block or infiltration of the wound through the perioperative period. Both interventions will use an equal volume of Ropivacaine 0.2% based on weight. Exploratory data will be collected for up to 30 days postoperatively.
- Being tested
- Regional Anesthesia, Wound infiltration, Ropivacaine 0.2% Injectable Solution
- Keywords
- Regional anesthesia
- Medical subject headings
- Heart Septal Defects, Atrial, Heart Septal Defects, Ventricular, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional AnesthesiaProcedure or surgery
Bilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2%
Wound infiltrationProcedure or surgery
Surgeon-delivered wound infiltration with Ropivacaine 0.2%
Ropivacaine 0.2% Injectable SolutionDrug
Ropivacaine 1.5 mL/kg will be used for both interventions
| Study group | Role | What they receive |
|---|---|---|
| Regional Anesthesia | Active comparator | Ultrasound guided blocks Receives: Procedure: Regional Anesthesia; Drug: Ropivacaine 0.2% Injectable Solution |
| Wound Infiltration | Active comparator | Surgeon-delivered wound infiltration Receives: Procedure: Wound infiltration; Drug: Ropivacaine 0.2% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Amount of Opioid Medications Administered
Postoperative opioid medication expressed in morphine equivalents per kilogram
Measured: Up to 12 hours after surgery
Secondary outcomes (3)
Total Amount of Opioid Medications Administered
Postoperative opioid medication expressed in morphine equivalents per kilogram
Measured: 12-24 hours after surgery; 24-48 hours after surgery; 12-48 hours hours after surgery
Total Amount of Opioid Medications Administered
Postoperative opioid medication expressed in morphine equivalents per kilogram
Measured: Up to 48 hours after surgery
Postoperative Pain Intensity AUC
Cumulative burden of pain over time was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale. Scores range from 0-10, with higher scores indicating greater pain.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start29 Mar 2023
- Primary completion18 Oct 2024
- Study completion22 Jan 2025
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 Atrial Septal DefectStudies of the same condition, open and under way.
- More trials run by Duke 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Society of Pediatric Anesthesia
- Responsible party
- Sponsor
- Investigators
- Lisa M Einhorn, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688670
- Sponsor's protocol ID
- PRO00111671
- Status last verified
- Aug 2025
- First submitted
- 9 Jan 2023
- Last updated
- 28 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Einhorn LM, Kharasch ED, Lim J, Fuller M, Turi JL, Jooste EH, Andrew BY, Ames WA. Combined Pecto-intercostal Fascial Plane and Rectus Sheath Blocks Versus Local Infiltration for Pain Management Following Pediatric Cardiac Surgery: A Randomized Clinical Trial. Anesth Analg. 2026 Jun 1;142(6):1189-1197. doi: 10.1213/ANE.0000000000007754. Epub 2025 Oct 1.
PubMed 41032451
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control With Regional Anesthesia Following Pediatric Cardiac Surgery: A Randomized Double-Blinded Pilot Study
- ClinicalTrials.gov ID
- NCT05688670
- Acronym / sponsor ID
- PRO00111671
- Keywords
- Regional anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Society of Pediatric Anesthesia
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Posted 28 Aug 2025
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 study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.
Detailed description
This is a single center, randomized, double blind investigation which will compare postoperative pain control indices, functional recovery metrics and patient/parental satisfaction for pediatric patients receiving an ultrasound guided regional anesthetic versus surgeon delivered wound infiltration in children undergoing primary atrial and ventricular septal defect repairs. Surgical and anesthesia care, with the exception of the technique of local anesthetic administration, are not altered for study purposes. Subjects are randomized 1:1 to either bilateral Pecto-Intercostal Fascial Block and unilateral Rectus Sheath Block or infiltration of the wound through the perioperative period. Both interventions will use an equal volume of Ropivacaine 0.2% based on weight. Exploratory data will be collected for up to 30 days postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional Anesthesia | Active comparator | Procedure: Regional Anesthesia, Drug: Ropivacaine 0.2% Injectable SolutionUltrasound guided blocks |
| Wound Infiltration | Active comparator | Procedure: Wound infiltration, Drug: Ropivacaine 0.2% Injectable SolutionSurgeon-delivered wound infiltration |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children less than 18 years old
- Presenting for primary atrial septal defect or ventricular septal defect repair
- Informed consent / assent provided
Key exclusion criteria (4 listed)
- Patients on opioid therapy at the time of surgery
- History of sternotomy
- Planned postoperative intubation
- Current diagnosis of a chronic pain syndrome.
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 |
|---|---|---|
| Regional AnesthesiaBilateral pecto-intercostal fascial plane block (PIFB) and unilateral rectus sheath block (RSB) with Ropivacaine 0.2% | Procedure or surgery | Regional Anesthesia |
| Wound infiltrationSurgeon-delivered wound infiltration with Ropivacaine 0.2% | Procedure or surgery | Wound Infiltration |
| Ropivacaine 0.2% Injectable SolutionRopivacaine 1.5 mL/kg will be used for both interventions | Drug | Regional Anesthesia, Wound Infiltration |
Primary outcome
Total Amount of Opioid Medications Administered
Time frame: Up to 12 hours after surgery
Postoperative opioid medication expressed in morphine equivalents per kilogram
3 secondary outcomes
Total Amount of Opioid Medications Administered
Time frame: 12-24 hours after surgery; 24-48 hours after surgery; 12-48 hours hours after surgery
Total Amount of Opioid Medications Administered
Time frame: Up to 48 hours after surgery
Postoperative Pain Intensity AUC
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41032451Einhorn LM, Kharasch ED, Lim J, Fuller M, Turi JL, Jooste EH, Andrew BY, Ames WA. Combined Pecto-intercostal Fascial Plane and Rectus Sheath Blocks Versus Local Infiltration for Pain Management Following Pediatric Cardiac Surgery: A Randomized Clinical Trial. Anesth Analg. 2026 Jun 1;142(6):1189-1197. doi: 10.1213/ANE.0000000000007754. Epub 2025 Oct 1.
- 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.
Lisa M Einhorn, MD principal investigator
Duke University
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 Regional Anesthesia, Wound infiltration and Ropivacaine 0.2% Injectable Solution in people with Atrial Septal Defect and Ventricular Septal Defect, run by Duke University 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 4 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 28 Aug 2025. 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 28 Aug 2025). 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?
Total Amount of Opioid Medications Administered (time frame: Up to 12 hours after surgery). 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 NCT05688670, 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 28 Aug 2025.