42 Participants NeededMy employer runs this trial

Ropivacaine for Pain Management in Pediatric Scoliosis Surgery

(ESPB Trial)

TR
SC
Overseen ByStephanie Chu
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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?

IS

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

I am having posterior spinal fusion surgery.
I have been diagnosed with adolescent idiopathic scoliosis or neuromuscular scoliosis.

Exclusion Criteria

I am having spinal deformity surgery that is not a posterior spinal fusion.
Patients with forms of scoliosis other than AIS or NM Scoliosis
I do not have an allergy or contraindication to ESPB with Ropivacaine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Postoperative Care

Participants undergo Posterior Spinal Fusion surgery and receive immediate postoperative care, including ESPB with Ropivacaine or standard pain protocol

1 week
Inpatient hospital stay

Postoperative Pain Management

Participants are monitored for pain management effectiveness using oral morphine equivalents and benzodiazepine doses, and pain scores are recorded

72 hours
Daily assessments

Physical Therapy and Recovery

Participants engage in physical therapy to achieve functional mobilization and are monitored until clearance for safe discharge

From postoperative day 1 to physical therapy clearance

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: ESPB with Ropivacaine + standard postoperative pain protocolExperimental Treatment1 Intervention
Group II: No ESPB + standard postoperative pain protocolActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

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 ...

Intraoperative 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.