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

Recruiting at3 trial locations

Overseen by Rachel M Thompson, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of California, Los Angeles

Must not be taking: Opioids

Disqualifiers: Allergy to injection, Epidural reaction

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Epidural Anesthesia for hip surgery in children with cerebral palsy?

Research shows that epidural anesthesia provides excellent pain relief for children with cerebral palsy undergoing hip surgery, as it offers continuous pain relief and reduces the need for other pain medications. It is considered superior to local infiltration analgesia for managing postoperative pain in these patients. ^{1 2 3 4 5}

Is regional anesthesia safe for children undergoing surgery?

Regional anesthesia, including epidural anesthesia, is generally safe for children, with large studies showing a low rate of complications. While serious complications like neurologic injury are rare, they are more likely with central blocks than peripheral ones, and experienced anesthesiologists can manage them effectively. ^{1 2 6 7 8}

How does the treatment for hip surgery in children with cerebral palsy differ from other treatments?

The treatment using epidural anesthesia and pain injection for hip surgery in children with cerebral palsy is unique because it combines regional anesthesia techniques to manage pain effectively while minimizing the use of opioids. This approach is particularly beneficial due to the complex nerve structure around the hip joint, providing comprehensive pain relief without the need for multiple injections. ^{9 10 11 12 13}

Research Team

Rachel M Thompson, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• Epidural Anesthesia (Procedure)
• Pain Injection (Procedure)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Thomas Rando

University of California, Los Angeles

Chief Medical Officer since 2023

MD from UCLA

Amir Naiberg

University of California, Los Angeles

Chief Executive Officer since 2024

JD from UCLA

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pediatric neuraxial blockade. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

[Regional anesthesia procedures in childhood: Austrian interdisciplinary recommendations on pediatric perioperative pain management]. [2021]

3. United States 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. [2022]

4. United States 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. [2023]

5. Sweden pubmed.ncbi.nlm.nih.gov

Epidural analgesia is superior to local infiltration analgesia in children with cerebral palsy undergoing unilateral hip reconstruction. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Updates on neurologic complications in pediatric regional anesthesia. [2021]

7. Italy pubmed.ncbi.nlm.nih.gov

Spinal epidural hematoma following epidural anesthesia. Case report. [2009]

8. United States 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. [2022]

9. China 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. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Periarticular Injection Versus Peripheral Nerve Blockade in Bilateral Total Hip Arthroplasty. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Pericapsular Nerve Group Block: An Excellent Option for Analgesia for Positional Pain in Hip Fractures. [2020]

12. Spain pubmed.ncbi.nlm.nih.gov

Bilateral pericapsular nerves group (PENG) block for analgesia in pediatric hip surgery. [2021]

13. Spain pubmed.ncbi.nlm.nih.gov

Bilateral pericapsular nerves group (PENG) block for analgesia in pediatric hip surgery. [2022]