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

NCT07561827 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 24-42517
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Adolescent Idiopathic Scoliosis (AIS); Neuromuscular Scoliosis; Adolescent Idiopathic Scoliosis

Keywords

posterior spinal fusion; pain management

Outcome Measures

Primary Outcomes (3)

• 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.

  Change from Baseline to 72 hours after surgery.

• 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.

  From Baseline to 24 hours after surgery.

• 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.

  From postoperative day 1 to physical therapy clearance.

Study Arms (2)

ESPB with Ropivacaine + standard postoperative pain protocol

EXPERIMENTAL

Erector spinae plan block (ESPB) with Ropivacaine and standard postoperative pain protocol

Drug: Ropivacaine Hydrocloride

No ESPB + standard postoperative pain protocol

NO INTERVENTION

No erector spinae plane block (ESPB) or type of injection and standard posteropative pain protocol

Interventions

Ropivacaine Hydrocloride DRUG

This drug is approved as a local anesthetic.

ESPB with Ropivacaine + standard postoperative pain protocol

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 30180150 BACKGROUND

• 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.

  PMID: 37159268 BACKGROUND

• 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.

  PMID: 36300557 BACKGROUND

• 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.

  PMID: 31776896 BACKGROUND

• 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.

  PMID: 32057483 BACKGROUND

• 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.

  PMID: 29704223 BACKGROUND

• 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.

  PMID: 35191639 BACKGROUND

• 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.

  PMID: 32357842 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ishaan Swarup, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tripta Rughwani

CONTACT

415-353-4701; tripta.rughwani@ucsf.edu

Stephanie Chu

CONTACT

415-353-1454; stephanie.chu4@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: June 6, 2025
• Primary Completion (Estimated): January 26, 2027
• Study Completion (Estimated): January 26, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)