Recruiting

Pain Injection vs. Epidural Anesthesia

Sponsor:

UCLA

Code:

NCT06189781

Conditions

Cerebral Palsy

Hip Dysplasia

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Ropivacaine injection

Bupivacaine, lidocaine, ropivacaine

Study Details

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

Study ID

NCT06189781

Start date

Dec 1, 2023

Status verified date

Jun, 2024

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pain Injection

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

active comparator: Epidural

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

Interventions

Ropivacaine injection

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.

Bupivacaine, lidocaine, ropivacaine

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

Primary outcome measure

  • Average postoperative narcotic consumption measured in morphine equivalents per kilograms of patient body weight [ Time Frame: First 48 hours after surgery ]

Central Contacts and Locations

Central contacts

Locations

Orthopaedic Institute for Children

Recruiting

Los Angeles, California, United States, 90007

Contacts

Nicole J Hung, MD

310-592-5180

Principal Investigator:

Rachel M Thompson, MD

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Rachel M Thompson, MD

UCLA Medical Center, Santa Monica

Recruiting

Santa Monica, California, United States, 90404

Contacts

Nicole J Hung, MD

310-592-5180

Principal Investigator:

Rachel M Thompson, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Jun 11, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2024-06-11.