Pain Injection vs Epidural Anesthesia for Hip Surgery in Children with Cerebral Palsy

Recruiting at 3 trial locations

Overseen By Nicole J Hung, MD

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Los Angeles

Must not be taking: Opioids

Disqualifiers: Allergy to injection, Epidural reaction

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Immediate perioperative period

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best way to manage pain after hip surgery in children with cerebral palsy (CP). It compares two methods: epidural anesthesia (a pain blocker injected near the spine) and a local anesthetic injection at the surgical site. The goal is to identify which method is more effective and has fewer side effects. Children with cerebral palsy undergoing hip surgery may be suitable candidates for this trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and it seeks to understand how it benefits a broader range of patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using opioids.

What is the safety track record for these treatments?

A previous study demonstrated that pain relief injections using multiple methods are safe and effective for adults, reducing post-surgery pain without major side effects. Research in children, particularly those with cerebral palsy, found these injections provided better pain relief and comfort after hip surgery. They also reduced the need for opioids, which can cause serious side effects like nausea and confusion.

Epidural anesthesia is a common method for managing pain in children with cerebral palsy. It effectively reduces pain and helps with muscle stiffness. However, it carries some risks, such as possible infection and complications from the procedure, especially in children with conditions like scoliosis.

Overall, studies have shown that both treatments are safe, but pain relief injections may have fewer side effects and complications compared to epidural anesthesia. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they offer potentially less invasive options for managing pain during hip surgery in children with cerebral palsy. Unlike traditional methods, such as general anesthesia or continuous epidural anesthesia, the experimental pain injection combines ropivacaine, epinephrine, and ketorolac, which may provide targeted pain relief with fewer systemic side effects. This localized approach could lead to quicker recovery times and a more comfortable postoperative experience for young patients. Additionally, the use of ketorolac, a non-steroidal anti-inflammatory drug, in the injection aims to reduce inflammation and enhance pain control, making it a promising alternative to existing treatments.

What evidence suggests that this trial's treatments could be effective for pain management in children with cerebral palsy?

This trial will compare pain injections with epidural anesthesia for managing pain after hip surgery in children with cerebral palsy. Research has shown that a combination of medications in pain injections can effectively manage pain, reducing the need for opioids, which often have many side effects. Studies have found that children receiving these injections experience less pain and become comfortable more quickly than those who do not. This method offers a promising alternative to traditional options like epidural anesthesia, which can pose risks for these children. Overall, pain injections seem to provide better pain relief with fewer complications. ^{1 2 4 6 7}

Who Is on the Research Team?

Rachel M Thompson, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for pediatric patients with cerebral palsy who are undergoing hip surgery. It's aimed at those who may have difficulty communicating their pain due to developmental delays or intellectual disabilities. Patients must be suitable candidates for either epidural anesthesia or surgical site injections.

Inclusion Criteria

I am under 18 years old.

I am having surgery to correct the bone in my upper leg.

I have been diagnosed with cerebral palsy or a similar condition.

Exclusion Criteria

Patients with a history of allergic reaction to any component of the pain injection

Patients with ongoing preoperative opioid use

Patients with a history of adverse reaction to epidural anesthesia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either epidural anesthesia or a multimodal surgical site injection during hip surgery

Immediate perioperative period

1 visit (in-person, surgical procedure)

Postoperative Monitoring

Participants' pain scores and narcotic consumption are monitored in the post-anesthesia care unit and inpatient ward

2-4 days

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including parent satisfaction assessment

2-3 weeks

1 visit (in-person, post-operative clinic)

What Are the Treatments Tested in This Trial?

Interventions

• Epidural Anesthesia
• Pain Injection

Trial Overview The study compares two pain management methods post-hip surgery: multimodal surgical site injections (using drugs like Ropivacaine) versus traditional epidural anesthesia. The goal is to see which method better controls pain without the side effects associated with opioids.

How Is the Trial Designed?

Group I: Pain Injection Experimental Treatment 1 Intervention

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

Group II: Epidural Active Control 1 Intervention

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

Epidural Anesthesia is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidural Anesthesia for:

• Pain management for surgical procedures
• Postoperative pain control

Approved in European Union as Epidural Anesthesia for:

• Pain management for surgical procedures
• Postoperative pain control
• Obstetric anesthesia

Approved in Canada as Epidural Anesthesia for:

• Pain management for surgical procedures
• Postoperative pain control

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

Regional anesthesia is crucial for effective pain management in children and should be performed by experienced practitioners who understand the unique anatomical and physiological differences in pediatric patients.

Ultrasound-guided techniques are recommended for regional anesthesia in children, as they enhance the safety and acceptance of the procedure, although specialized techniques should be reserved for expert centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Regional anesthesia procedures in childhood: Austrian interdisciplinary recommendations on pediatric perioperative pain management]. Messerer, B., Platzer, M., Justin, C., et al.[2021]

A 5-year-old girl with cerebral palsy successfully managed her postoperative pain after hip surgery using a bilateral PENG block and femoral cutaneous nerve block, which effectively targeted the sensory nerves of the hip joint.

This technique simplifies pain management by covering all relevant nerves with fewer injections, potentially reducing the risk of complications associated with standard regional anesthesia methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral pericapsular nerves group (PENG) block for analgesia in pediatric hip surgery. Anido Guzmán, JA., Javier Robles Barragán, F., Funcia de la Torre, I., et al.[2021]

A 5-year-old girl with cerebral palsy successfully managed her postoperative pain after hip surgery using a bilateral PENG block and femoral cutaneous nerve block, which effectively targeted the complex innervation of the hip joint.

This technique simplifies pain management by covering all relevant sensory nerves with fewer injections, potentially reducing the risk of complications associated with standard regional anesthesia methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral pericapsular nerves group (PENG) block for analgesia in pediatric hip surgery. Anido Guzmán, JA., Robles Barragán, FJ., Funcia de la Torre, I., et al.[2022]

A large prospective study involving 85,412 pediatric anesthesia procedures found that regional anesthesia, particularly central blocks, is generally safe, with a low overall complication rate of 0.9 per 1000 procedures, primarily occurring in central blocks.

The study highlights that complications from peripheral nerve blocks are extremely rare (zero incidents reported), suggesting that pediatric anesthesiologists should consider using these techniques more frequently as a safer alternative to central blocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology and morbidity of regional anesthesia in children: a one-year prospective survey of the French-Language Society of Pediatric Anesthesiologists. Giaufré, E., Dalens, B., Gombert, A.[2022]

In a study of 60 patients undergoing total hip arthroplasty, the pericapsular nerve group (PENG) block provided comparable pain relief to periarticular infiltration (PAI) 12 hours post-surgery, indicating its effectiveness as an analgesic technique.

The results showed no significant differences in opioid consumption or quality of recovery between the two groups, suggesting that both methods are effective for managing postoperative pain without compromising recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the analgesic efficacy of periarticular infiltration and pericapsular nerve group block for total hip arthroplasty: a randomized, non-inferiority study. Zheng, L., Jo, Y., Hwang, J., et al.[2022]

Regional anesthetic techniques, such as spinal and epidural blocks, provide excellent pain relief for children during and after surgery with minimal physiological changes, making them a safe option when performed by experienced practitioners.

These techniques can reduce the amount of general anesthesia needed, leading to quicker recovery times and a more comfortable postoperative experience for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric neuraxial blockade. Pullerits, J., Holzman, RS.[2019]

Epidural anesthesia is commonly used for pain relief during and after limb surgery and is generally regarded as very safe, with serious complications occurring in only 0.1-1 per 10,000 injections.

The case presented highlights a rare but serious complication: an acute lumbar epidural hematoma, which can occur following epidural anesthesia, emphasizing the need for careful monitoring and risk assessment during this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal epidural hematoma following epidural anesthesia. Case report. Ulivieri, S., Oliveri, G.[2009]

In a study of 54 children with cerebral palsy undergoing hip reconstruction, those who received lumbar plexus blocks (LPB) experienced significantly lower postoperative pain scores and required less narcotic medication compared to those receiving general anesthesia alone or with an epidural.

Patients in the LPB group also had a lower average heart rate and shorter hospital stay, indicating that this pain management technique may lead to better overall recovery outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumbar Plexus Nerve Blocks for Perioperative Pain Management in Cerebral Palsy Patients Undergoing Hip Reconstruction: More Effective Than General Anesthesia and Epidurals. Trionfo, A., Zimmerman, R., Gillock, K., et al.[2022]

In a study of 60 children with cerebral palsy undergoing hip reconstruction, those who received preoperative fascia iliaca (FI) blocks experienced significantly lower pain scores on the first postoperative day compared to those who received epidural anesthesia.

Patients in the FI block group also used fewer opioids and had shorter hospital stays, indicating that FI blocks may be a more effective pain management strategy than epidural anesthesia in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fascia Iliaca Pain Block Results in Lower Overall Opioid Usage and Shorter Hospital Stays than Epidural Anesthesia After Hip Reconstruction in Children With Cerebral Palsy. Laron, D., Kelley, J., Chidambaran, V., et al.[2023]

In a study involving 18 children with cerebral palsy undergoing unilateral hip reconstruction, epidural analgesia significantly reduced postoperative pain compared to local infiltration analgesia (LIA) and a placebo, with pain scores measured 4 hours post-surgery showing lower levels in the epidural group.

Epidural analgesia also resulted in lower opioid consumption compared to both LIA and placebo groups, indicating it may be a more effective and safer option for managing postoperative pain in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural analgesia is superior to local infiltration analgesia in children with cerebral palsy undergoing unilateral hip reconstruction. Kjeldgaard Pedersen, L., Nikolajsen, L., Rahbek, O., et al.[2022]

Regional anesthesia is a safe and effective option for pain management in pediatric patients, with safety levels comparable to those in adults, despite concerns about potential neurologic injuries.

Large database reviews indicate that the risk of neurologic complications from regional blocks in children is low, supporting the use of this technique in pediatric anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates on neurologic complications in pediatric regional anesthesia. Chun, Y., Phillips, M., Suresh, S.[2021]

In a case study of a patient undergoing bilateral total hip arthroplasty, preoperative motor-sparing peripheral nerve blocks (PNB) provided better postoperative pain control compared to periarticular injection (PAI) with liposomal bupivacaine.

The patient experienced consistently lower pain scores for the hip treated with PNB over the first five days after surgery, highlighting the efficacy of PNB in enhancing recovery and patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periarticular Injection Versus Peripheral Nerve Blockade in Bilateral Total Hip Arthroplasty. Sivco, C., Townsend, D., Leslie, MP., et al.[2023]

In a series of ten cases, the pericapsular nerve group (PENG) block was successfully used to provide effective pain relief for patients with hip fractures before positioning them for spinal anesthesia procedures.

The PENG block is a new regional anesthesia technique that not only alleviates pain from hip fractures but also facilitates easier patient positioning for subsequent anesthesia, making it a valuable option in emergency settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pericapsular Nerve Group Block: An Excellent Option for Analgesia for Positional Pain in Hip Fractures. Acharya, U., Lamsal, R.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39140418/

Efficacy of a Multimodal Surgical Site Injection for ... In patients with CP undergoing hip reconstruction, surgical-site injection with a multimodal analgesic combination improves pain control and reduces narcotic ...

2. luskinoic.org luskinoic.org/improving-pain-management-after-hip-surgery-in-children-with-cerebral-palsy-a-new-multicenter-study/

Improving Pain Management After Hip Surgery in Children ... The findings showed that the multimodal injection led to better pain control, faster comfort, and reduced reliance on opioids compared to ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/65/NCT04074265/Prot_SAP_001.pdf

Official Title: Efficacy of a Peri-Operative Surgical-Site Efficacy of a Peri-Operative Surgical-Site, Multimodal Drug Injection in Pediatric Patients with. Cerebral Palsy Undergoing Hip Surgery: A Randomized Controlled ...

4. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT06189781

UCLA Cerebral Palsy Trial → Pain Injection Versus Epidural ... As described in Preliminary Data section below, the investigators' pilot randomized control trial demonstrated significantly decreased pain ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04074265

Peri-operative Use of a Pain Injection in Pediatric Patients ... The goal of this study is to assess the efficacy of a surgical-site pain injection administered in pediatric patients with cerebral palsy undergoing major hip ...

6. trialx.com trialx.com/clinical-trials/listings/256076/pain-injection-versus-epidural-anesthesia-for-hip-surgery-in-pediatric-patients-with-cerebral-palsy/

Pain Injection Versus Epidural Anesthesia for Hip Surgery in ... Preliminary data from our study group's pilot randomized control trial comparing the safety and efficacy of a multimodal surgical site injection to placebo ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/447816

Pain Injection Versus Epidural Anesthesia for Hip Surgery in ... Preliminary data from our study group's pilot randomized control trial comparing the safety and efficacy of a multimodal surgical site injection to placebo ...