Microtia, CongenitalNCT03729427
Rib Microtia and the Erector Spinae Plane (ESP) Block
A study testing Erector Spinae Plane Block in people with Microtia, Congenital and Microtia, run by Stanford University at 1 site in United States.
Trial summary
The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. This study is being performed to assess the effectiveness of this technique in reducing post-operative pain scores and opiate requirements in pediatric and adult… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Microtia, Congenital, Microtia, Anesthesia, Local
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2025to Nov 2026
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 2-17
- Able to consent (if greater than 7 years) and have parental consent
- Pediatric patients undergoing rib cartilage resection surgeries
Who cannot join
- Participants who do not consent or have parental consent
- Patients who are clinically unstable or requires urgent/emergent intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
About this study
Official title: Erector Spinae Plane Block for Rib Cartilage Graft Reconstruction Surgery
The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. This study is being performed to assess the effectiveness of this technique in reducing post-operative pain scores and opiate requirements in pediatric and adult patients undergoing rib cartilage grafting surgeries.
- Conditions
- Microtia, Congenital, Microtia, Anesthesia, Local, Anesthesia
- Being tested
- Erector Spinae Plane Block
- Keywords
- Erector Spinae Plane, Erector Spiane Plane Block, Rib Cartilage
- Medical subject headings
- Congenital Microtia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Erector Spinae Plane block for patents undergoing rib cartilage grafting surgeries
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | ESP Block Receives: Procedure: Erector Spinae Plane Block |
| Control Arm | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate Intake in Morphine Equivalents in Both Control and Treatment Group
Measured: Duration of procedure and postoperative recovery (throughout study completion, typically 4-5 days)
Evaluating Pain Scores Using 0-10 Numeric Pain Scale (0=No Pain, 10=Worst Pain)
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
Measured: Duration of Study (Typically 4-5 days)
Evaluating Pain Scores Using Wong-Baker FACES Pain Rating Scale
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
Measured: Duration of Study (Typically 4-5 days)
Evaluating Pain Scores Using Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
Measured: Duration of Study (Typically 4-5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Why it stopped: No participants were enrolled in the study due to numerous transitions of research staff and support since 2018.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Microtia, CongenitalStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Ho Ban Tsui, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729427
- Sponsor's protocol ID
- 45160
- Status last verified
- Apr 2025
- First submitted
- 29 Oct 2018
- Last updated
- 4 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
PubMed 28919152Luftig J, Mantuani D, Herring AA, Dixon B, Clattenburg E, Nagdev A. Successful emergency pain control for posterior rib fractures with ultrasound-guided erector spinae plane block. Am J Emerg Med. 2018 Aug;36(8):1391-1396. doi: 10.1016/j.ajem.2017.12.060. Epub 2017 Dec 28.
PubMed 29301653Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.
PubMed 28203765
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Rib Cartilage Graft Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT03729427
- Acronym / sponsor ID
- 45160
- Conditions
- Microtia, Congenital, Microtia, Anesthesia, Local, Anesthesia
- Keywords
- Erector Spinae Plane, Erector Spiane Plane Block, Rib Cartilage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled in the study due to numerous transitions of research staff and support since 2018.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 2 Nov 2018 (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 erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. This study is being performed to assess the effectiveness of this technique in reducing post-operative pain scores and opiate requirements in pediatric and adult patients undergoing rib cartilage grafting surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Procedure: Erector Spinae Plane BlockESP Block |
| Control Arm | No intervention | –Standard of Care |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages 2-17
- Able to consent (if greater than 7 years) and have parental consent
- Pediatric patients undergoing rib cartilage resection surgeries
Key exclusion criteria (2 listed)
- Participants who do not consent or have parental consent
- Patients who are clinically unstable or requires urgent/emergent intervention
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 |
|---|---|---|
| Erector Spinae Plane BlockErector Spinae Plane block for patents undergoing rib cartilage grafting surgeries | Procedure or surgery | Treatment Arm |
Primary outcome
Opiate Intake in Morphine Equivalents in Both Control and Treatment Group
Time frame: Duration of procedure and postoperative recovery (throughout study completion, typically 4-5 days)
Evaluating Pain Scores Using 0-10 Numeric Pain Scale (0=No Pain, 10=Worst Pain)
Time frame: Duration of Study (Typically 4-5 days)
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
Evaluating Pain Scores Using Wong-Baker FACES Pain Rating Scale
Time frame: Duration of Study (Typically 4-5 days)
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
Evaluating Pain Scores Using Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale
Time frame: Duration of Study (Typically 4-5 days)
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
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 4 May 2025.
- Background: PubMed 28919152Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
- Background: PubMed 29301653Luftig J, Mantuani D, Herring AA, Dixon B, Clattenburg E, Nagdev A. Successful emergency pain control for posterior rib fractures with ultrasound-guided erector spinae plane block. Am J Emerg Med. 2018 Aug;36(8):1391-1396. doi: 10.1016/j.ajem.2017.12.060. Epub 2017 Dec 28.
- Background: PubMed 28203765Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block in people with Microtia, Congenital and Microtia, run by Stanford 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 2 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 4 May 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.
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?
Opiate Intake in Morphine Equivalents in Both Control and Treatment Group (time frame: Duration of procedure and postoperative recovery (throughout study completion, typically 4-5 days)). The study lists 4 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 NCT03729427, which also lists 3 linked publications.
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 May 2025.