Ropivacaine for Pain Management in Pediatric Scoliosis Surgery

(ESPB Trial)

Overseen By Stephanie Chu

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: University of California, San Francisco

Must not be taking: Opioids

Disqualifiers: Other scoliosis, Other surgeries, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Ishaan Swarup, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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

How Is the Trial Designed?

Group I: ESPB with Ropivacaine + standard postoperative pain protocol Experimental Treatment 1 Intervention

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

Group II: No ESPB + standard postoperative pain protocol Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+