Ropivacaine for Pain Management in Pediatric Scoliosis Surgery
(ESPB Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a special pain relief method using ropivacaine, known as an erector spinae plane block (ESPB), can assist children undergoing spinal surgery for scoliosis. The researchers seek to discover if this treatment can reduce pain and lessen the need for other pain medications post-surgery. Children with Adolescent Idiopathic Scoliosis or Neuromuscular Scoliosis preparing for spinal fusion surgery are suitable candidates for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking pain management solution.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes patients who are taking pre-operative opioids.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that ropivacaine is generally safe for surgical anesthesia and pain management. The FDA has approved it for these uses, confirming its safety. Studies have found that ropivacaine is often well-tolerated as a local anesthetic, which temporarily numbs a specific area, during surgeries like cesarean sections.
One study found that ropivacaine provided effective pain relief in children's spinal surgery. Another report showed that continuous use of ropivacaine in children undergoing major scoliosis surgery successfully managed pain without major side effects.
Overall, existing evidence supports ropivacaine as a safe option for managing pain in surgical settings, including for children undergoing spinal surgery.12345Why do researchers think this study treatment might be promising for scoliosis?
Researchers are excited about using Ropivacaine for pain management in pediatric scoliosis surgery because it offers a targeted approach through the erector spinae plane block (ESPB). Unlike standard treatments that often rely on systemic opioids, Ropivacaine provides localized pain relief, potentially reducing the need for opioids and their associated side effects. This method could enhance recovery by managing pain more effectively right at the source. Additionally, by integrating Ropivacaine with the standard postoperative pain protocol, there is hope for improved overall pain management outcomes for young patients undergoing this surgery.
What evidence suggests that the ESPB with Ropivacaine is effective for pain management in pediatric scoliosis surgery?
Research has shown that using ropivacaine in an erector spinae plane block (ESPB) can reduce pain after spinal surgery. In this trial, one group of participants will receive ESPB with ropivacaine alongside the standard postoperative pain protocol. Studies from Asia have found that ESPB significantly decreases pain in the first 24 hours after surgery. Another study discovered that directly applying ropivacaine to the surgical area improved immediate pain relief. These findings suggest that ropivacaine can effectively manage pain after surgery for children with scoliosis, potentially reducing the need for additional pain medication.12567
Who Is on the Research Team?
Ishaan Swarup, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for children and teens with adolescent idiopathic scoliosis or neuromuscular scoliosis who are having posterior spinal fusion surgery. It excludes those with other types of scoliosis, different spine surgeries, allergies to the anesthetic used, or those already taking opioid painkillers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Immediate Postoperative Care
Participants undergo Posterior Spinal Fusion surgery and receive immediate postoperative care, including ESPB with Ropivacaine or standard pain protocol
Postoperative Pain Management
Participants are monitored for pain management effectiveness using oral morphine equivalents and benzodiazepine doses, and pain scores are recorded
Physical Therapy and Recovery
Participants engage in physical therapy to achieve functional mobilization and are monitored until clearance for safe discharge
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ropivacaine Hydrochloride
Trial Overview
The study tests whether an injection called erector spinae plane block (ESPB) using ropivacaine can better control pain after back surgery in kids with certain types of scoliosis compared to standard care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Erector spinae plan block (ESPB) with Ropivacaine and standard postoperative pain protocol
No erector spinae plane block (ESPB) or type of injection and standard posteropative pain protocol
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Citations
Posterior spinal fusion for adolescent idiopathic scoliosis and ...
The aims of this QI were to (1) minimize opioid usage, (2) decrease pain scores, and (3) decrease length of stay below our previously reported ...
2.
journals.lww.com
journals.lww.com/spineopen/fulltext/2026/03010/intraoperative_erector_spinae_plane_block_with.17.aspxIntraoperative Erector Spinae Plane Block With...
The first reports of efficacy of ESPB in spine surgery were from Asia and showed promising reductions in pain in the first 24 hours ...
Postoperative pain management in patients undergoing ...
Intravenous patient-controlled analgesia with opioids has been the mainstay of postoperative pain management in these patients.
Postoperative Pain Management in Pediatric Spinal Fusion ...
This article reviews and summarizes current evidence and knowledge gaps regarding postoperative analgesia after pediatric posterior spine fusion for adolescent ...
Comparison of the Efficacy and Safety Profiles of a Mixed ' ...
Local Infiltration with Ropivacaine Improves Immediate Postoperative Pain Control After Hemorrhoidal Surgery. Dis Colon Rectum 2002 Jan;45(1): ...
Effect of a Surgeon-Directed Cocktail of Ropivacaine ...
Conclusions Surgeon-directed cocktail therapy alone is insufficient to achieve significant improvements in pain control, as evidenced by the minimal impact on ...
Australian Public Assessment Report for Ropivacaine
Dowling et al. 200315. Improved pain control after cardiac surgery: results of a randomised, double- blind, clinical trial. Forastiere et al.
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