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Adolescent Idiopathic Scoliosis (AIS)Phase 3ESPBNCT07561827

The Effect of Erector Spinae Plane Block (ESPB) on Pediatric Pain Management Following Posterior Spinal Fusion (PSF) Surgery

A Phase 3 study testing Ropivacaine Hydrocloride in people with Adolescent Idiopathic Scoliosis (AIS) and Neuromuscular Scoliosis, run by University of California, San Francisco at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is being done to better understand the efficacy of an erector spinae plane block (ESPB) in pain management for children with Adolescent Idiopathic Scoliosis or Neuromuscular Scoliosis undergoing Posterior Spinal Fusion surgery. Read more about this study

Who is it for?
Ages 10 to 18 years
What is being tested?
Ropivacaine Hydrocloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
6 Jun 2025to 26 Jan 2027
Phase
Phase 3
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 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Diagnosis of Adolescent Idiopathic Scoliosis (AIS) or neuromuscular scoliosis
  • Undergoing Posterior Spinal Fusion (PSF) Surgery

Who cannot join

  • Patients with forms of scoliosis other than AIS or NM Scoliosis.
  • Patients undergoing a spinal deformity correction surgery other than Posterior Spinal Fusion Surgery
  • Allergy or other contraindication to erector spinae plane block (ESPB) with Ropivacaine patients who are taking pre-operative opioids

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tripta Rughwani contact

415-353-4701

tripta.rughwani@ucsf.edu

Stephanie Chu contact

415-353-1454

stephanie.chu4@ucsf.edu

United States1 site, 1 recruiting

  • University of California San Francisco

    San Francisco, California, 94158

    Tripta Rughwani, 415-353-4701, tripta.rughwani@ucsf.edu

    Stephanie Chu, 415-353-1454, stephanie.chu4@ucsf.edu

    Recruiting

Other trials in United States

About this study

This study is being done to better understand the efficacy of an erector spinae plane block (ESPB) in pain management for children with Adolescent Idiopathic Scoliosis or Neuromuscular Scoliosis undergoing Posterior Spinal Fusion surgery. The study team is trying to find out if receiving the ESPB leads to less pain and less need for pain medication after surgery.

The ESPB involves an injection of a local anesthetic, ropivacaine, into your child's back muscles to help block pain signals.

Being tested
Ropivacaine Hydrocloride
Keywords
posterior spinal fusion, pain management
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine HydroclorideDrug

    This drug is approved as a local anesthetic.

Study groups in NCT07561827
Study groupRoleWhat they receive
ESPB with Ropivacaine + standard postoperative pain protocolExperimentalErector spinae plan block (ESPB) with Ropivacaine and standard postoperative pain protocol
Receives: Drug: Ropivacaine Hydrocloride
No ESPB + standard postoperative pain protocolNo interventionNo erector spinae plane block (ESPB) or type of injection and standard posteropative pain protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare Oral Morphine Equivalents and Benzodiazepine Doses used in the first 72 hours after surgery among patients who have a ESPB with standard postoperative pain protocols versus those with standard protocols alone.

    Institutional pain management protocol: patients have a hydromorphone patient-controlled analgesia pump until post-operative day 1 and as needed (PO) methadone two times a day, as well as PO oxycodone every 4 hours as needed for moderate pain and IV hydromorphone every 2 hours as needed for severe pain. PO diazepam is available every 6 hours for muscle spasms. The oral morphine equivalents and benzodiazepine doses used in the first 72 hours after surgery will be the primary method of assessing postoperative pain and muscle spasms respectively.

    Measured: Change from Baseline to 72 hours after surgery.

  2. Evaluate if combining ESPBs with standard postoperative pain protocols reduce postoperative pain scores in the first 24 hours postoperatively as compared to standard protocols alone.

    Pain will be measured on a numerical scale from zero to ten, with zero being no pain at all and ten being the worst pain you have ever felt. Scores will be gathered at multiple time points the day of surgery, and post-op day 1, 2 and 3. We will take the average pain score. These numerical pain scores will be the secondary method of assessing postoperative pain.

    Measured: From Baseline to 24 hours after surgery.

  3. Assess time to clearance from physical therapy among patients who have a ESPB with standard postoperative pain protocols versus those with standard protocols alone.

    Time to clearance from physical therapy (PT) is a measure that demonstrates the amount of time required to obtain a functional level of mobilization after surgery. This mobilization is often pain limited. For neuromuscular patients with mobility limitations, aim 3 will be measured based on when patients are cleared by PT for safe discharge home. We will measure time to clearance in both groups.

    Measured: From postoperative day 1 to physical therapy clearance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study start6 Jun 2025
  3. Primary completion26 Jan 2027 (estimated)
  4. Study completion26 Jan 2027 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07561827
Sponsor's protocol ID
24-42517
Acronym
ESPB
Status last verified
Apr 2026
First submitted
24 Apr 2026
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chin KJ, Lewis S. Opioid-free Analgesia for Posterior Spinal Fusion Surgery Using Erector Spinae Plane (ESP) Blocks in a Multimodal Anesthetic Regimen. Spine (Phila Pa 1976). 2019 Mar 15;44(6):E379-E383. doi: 10.1097/BRS.0000000000002855.

    PubMed 30180150

  • Changoor S, Giakas A, Sacks K, Asma A, Lang RS, Yorgova P, Rogers K, Gabos PG, Shah SA. The Role of Liposomal Bupivacaine in Multimodal Pain Management Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis: Faster and Farther With Less Opioids. Spine (Phila Pa 1976). 2024 Jan 15;49(2):E11-E16. doi: 10.1097/BRS.0000000000004702. Epub 2023 May 1.

    PubMed 37159268

  • Akesen S, Guler SB, Akesen B. Bilateral bi-level erector spinae plane blocks in scoliosis surgery: a retrospective comparative study. Acta Orthop Traumatol Turc. 2022 Sep;56(5):327-332. doi: 10.5152/j.aott.2022.22019.

    PubMed 36300557

  • Tsui BCH, Esfahanian M, Lin C, Policy J, Vorhies J. Moving toward patients being pain- and spasm-free after pediatric scoliosis surgery by using bilateral surgically-placed erector spinae plane catheters. Can J Anaesth. 2020 May;67(5):621-622. doi: 10.1007/s12630-019-01543-0. Epub 2019 Nov 27. No abstract available.

    PubMed 31776896

  • Diwan SM, Yamak Altinpulluk E, Khurjekar K, Nair A, Dongre H, Turan A. Bilateral erector spinae plane block for scoliosis surgery: Case series. Rev Esp Anestesiol Reanim (Engl Ed). 2020 Mar;67(3):153-158. doi: 10.1016/j.redar.2019.11.012. Epub 2020 Feb 11. English, Spanish.

    PubMed 32057483

  • Melvin JP, Schrot RJ, Chu GM, Chin KJ. Low thoracic erector spinae plane block for perioperative analgesia in lumbosacral spine surgery: a case series. Can J Anaesth. 2018 Sep;65(9):1057-1065. doi: 10.1007/s12630-018-1145-8. Epub 2018 Apr 27.

    PubMed 29704223

  • Vergari A, Frassanito L, DI Muro M, Nestorini R, Chierichini A, Rossi M, DI Stasio E. Bilateral lumbar ultrasound-guided erector spinae plane block versus local anesthetic infiltration for perioperative analgesia in lumbar spine surgery: a randomized controlled trial. Minerva Anestesiol. 2022 Jun;88(6):465-471. doi: 10.23736/S0375-9393.22.15950-X. Epub 2022 Feb 22.

    PubMed 35191639

  • Kendall MC, Alves L, Traill LL, De Oliveira GS. The effect of ultrasound-guided erector spinae plane block on postsurgical pain: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 May 1;20(1):99. doi: 10.1186/s12871-020-01016-8.

    PubMed 32357842

  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

    PubMed 27501016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ropivacaine Hydrocloride in people with Adolescent Idiopathic Scoliosis (AIS) and Neuromuscular Scoliosis, run by University of California, San Francisco 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 2 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: looking for participants now, as of the sponsor's last update on 1 May 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Tripta Rughwani (415-353-4701, tripta.rughwani@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare Oral Morphine Equivalents and Benzodiazepine Doses used in the first 72 hours after surgery among patients who have a ESPB with standard postoperative pain protocols versus those with standard protocols alone. (time frame: Change from Baseline to 72 hours after surgery.). The study lists 3 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 NCT07561827, which also lists 9 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 1 May 2026.

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