Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy

NCT06189781 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB#23-000902
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

Brief Summary

Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. This is especially true in patients with cerebral palsy (CP), who often have concomitant developmental delay, intellectual disability and verbal limitations. Current literature indicates pain as a common experience for children with CP but has been understudied in this population. Moreover, inadequate post-operative pain control can result in negative physiologic and psychological complications and lead to poor surgical outcomes. Currently, perioperative pain management following orthopaedic procedures in pediatric patients follows traditional protocols that rely on the administration of opioid medications despite their known adverse side effects including nausea, vomiting, itching, constipation, urinary retention, confusion, and respiratory depression. Epidural anesthesia is a key modality in traditional pain management for pediatric patients with CP given its proven efficacy in decreasing pain and managing spasticity. Yet, administering epidural anesthesia in this patient population poses several risks including damage to preexisting intrathecal baclofen pumps, iatrogenic infection, and technically demanding insertion given high rates of concomitant neuromuscular scoliosis. Alternatively, multimodal analgesic injections theoretically offer an efficacious adjunct to traditional pain management protocols with a lower risk profile. Preliminary data from our study group's pilot randomized control trial comparing the safety and efficacy of a multimodal surgical site injection to placebo showed decreased pain scores and narcotic consumption postoperatively in this patient population. Based on these promising results, the objective of this randomized control trial is to evaluate the efficacy of a multimodal surgical site injection compared to epidural anesthesia for postoperative pain control following operative management of hip dysplasia in pediatric patients with CP.

Conditions

Cerebral Palsy; Hip Dysplasia; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Average postoperative narcotic consumption measured in morphine equivalents per kilograms of patient body weight

  This describes one outcome measure where the amount of opiates consumed will be expressed in morphine equivalents divided by the body weight of patients measured in kilograms.

  First 48 hours after surgery

Secondary Outcomes (3)

• Postoperative pain scores measured by Visual Analogue Scale/Faces Pain Scale/Face, Legs, Activity, Cry, Consolability Scale

  2-4 days

• Hospital length of stay measured in days

  2-4 days

• Parent satisfaction measured on a scale of 1-5

  2-3 weeks postoperatively

Study Arms (2)

Pain Injection

EXPERIMENTAL

The local anesthetic group will be injected with a combination of ropivacaine, epinephrine, and ketorolac.

Drug: Ropivacaine injection

Epidural

ACTIVE COMPARATOR

The control group will receive epidural anesthesia. Lumbar epidural anesthesia will be started intra-operatively.

Drug: Bupivacaine, lidocaine, ropivacaine

Interventions

Ropivacaine injection DRUG

The local anesthetic group will be injected with ropivacaine 2mg/mL (3mg/kg), epinephrine 1mg/mL (0.5mg), and ketorolac 30mg/mL (0.5mg/kg). The maximum dose of ropivacaine regardless of patient weight will be 200mg. This is based on recommended maximum dose protocols from our anesthesia colleagues. If bilateral hips are involved, the total amount will be split evenly between the two sides.

Pain Injection

Bupivacaine, lidocaine, ropivacaine DRUG

The lumbar epidural group will receive a combination of either/or bupivacaine, lidocaine, and ropivacaine, which will be monitored by the anesthesia team.

Epidural

Eligibility Criteria

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

You may qualify if:

• under 18 years old
• diagnosis of cerebral palsy or similar neuromuscular disease
• undergoing uni- or bilateral proximal femoral osteotomy

You may not qualify if:

• ongoing preoperative opioid use
• history of allergic reaction to any component of the pain injection
• history of adverse reaction to epidural anesthesia

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Northwestern University: collaborator

Study Sites (4)

Orthopaedic Institute for Children

Los Angeles, California, 90007, United States

RECRUITING

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

RECRUITING

UCLA Medical Center, Santa Monica

Santa Monica, California, 90404, United States

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Related Publications (16)

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MeSH Terms

Conditions

Cerebral Palsy; Hip Dislocation; Pain, Postoperative

Interventions

Ropivacaine; Bupivacaine; Lidocaine

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Study Officials

• Rachel M Thompson, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel M Thompson, MD

CONTACT

213-742-1369; rathompson@mednet.ucla.edu

Nicole J Hung, MD

CONTACT

310-592-5180; nhung@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Cerebral Palsy

Model Details: Patients will be assigned to either treatment/intervention group (injection only) or control (epidural only). All other aspects of care will be identical between the two groups.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 5, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)