Epidural Analgesia for Pediatric Surgery

JR
CR
Overseen ByCatherine Roth, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of pain relief after surgery in children: a constant flow of pain medication (continuous infusion) and timed doses (intermittent bolus) through an epidural. Researchers aim to determine which method better manages pain and reduces the need for additional pain medication. They will also assess factors such as how soon children can resume normal eating and any side effects like low blood pressure. Children under 18 who have undergone a Kelly procedure or similar surgery and require at least three days of epidural pain relief may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to enhance understanding of effective pain management in children after surgery.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both continuous epidural infusion (CEI) and programmed intermittent epidural bolus (PIEB) are generally safe for managing pain in children after surgery.

For CEI with ropivacaine, studies have found it provides safe and effective pain relief, similar to other anesthetics like bupivacaine, without serious side effects. One study confirmed that epidural pain relief is safe and effective after various surgeries, including those for spinal issues.

When using chloroprocaine in CEI, results are mixed. Some studies report excellent pain relief with minor side effects, while others note a higher chance of side effects compared to other drugs, though the evidence is not consistent.

For PIEB, research suggests it may spread pain relief medication effectively, improving pain control without major side effects. In some cases, it even reduces the need for extra pain medication.

Overall, both methods appear well-tolerated, but individual responses can vary. Discuss any concerns with the medical team involved in the trial.12345

Why are researchers excited about this trial?

Researchers are excited about the trial exploring different methods of epidural analgesia for pediatric surgery because it aims to compare the effectiveness of continuous infusion versus programmed intermittent bolus of anesthetics. Unlike traditional methods, which often involve patient-controlled epidural analgesia, these techniques are managed without patient involvement, allowing for potentially more consistent pain management. The continuous infusion method delivers a steady flow of anesthetic, which might offer more stable pain relief, while the intermittent bolus approach provides periodic doses that could maximize pain control with potentially lower overall drug usage. By comparing these innovative delivery methods, researchers hope to discover more effective ways to manage pain for children undergoing surgery.

What evidence suggests that this trial's treatments could be effective for pediatric post-surgical pain management?

This trial will compare two methods of administering epidural analgesia for pediatric surgery: continuous epidural infusion (CEI) and programmed intermittent epidural bolus (PIEB). Studies have shown that both chloroprocaine and ropivacaine effectively relieve pain after surgery. In this trial, some participants will receive chloroprocaine, which, when administered continuously, reduces pain and the need for additional pain medication in babies and newborns. Research also suggests that administering chloroprocaine in small doses at intervals can improve surgical outcomes by better managing pain. Other participants will receive ropivacaine, which, whether given continuously or in small doses, significantly reduces opioid use and increases patient satisfaction. Administering ropivacaine in small doses at intervals, compared to continuous infusion, provides better pain relief and uses less anesthetic. These findings indicate promising benefits for both medications in managing postoperative pain in children.16789

Who Is on the Research Team?

GV

Giorgio Veneziano, MD

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children who have had surgery for bladder exstrophy and need pain control after their operation. Patients with certain medical conditions or complications may not be eligible, but specific exclusions are not listed.

Inclusion Criteria

I have had a Kelly procedure or similar surgery to bring tissues together.
I am under 18 years old.
I will need epidural pain relief for at least 72 hours after surgery.

Exclusion Criteria

Allergy to chlorhexidine, Dermabond, or Tegaderm CHG dressing
Epidural pump unable to be initiated in the operating room or within 30 minutes of arrival to PACU
I am not taking blood thinners that are unsafe with spinal or epidural anesthesia.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either programmed intermittent epidural bolus (PIEB) or continuous epidural infusion (CEI) for postoperative analgesia

3 days
Frequent monitoring visits during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores, opioid consumption, and incidence of complications

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Chloroprocaine continuous infusion
  • Chloroprocaine intermittent bolus
  • Ropivacaine (Epidural analgesia) continuous infusion
  • Ropivacaine (Epidural analgesia) intermittent bolus

Trial Overview

The study compares two ways of giving epidural pain relief—either as a steady continuous infusion or as programmed intermittent doses (boluses)—using either ropivacaine or chloroprocaine. Children are randomly assigned to one method after surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Programmed intermittent epidural bolus (PIEB)Experimental Treatment2 Interventions
Group II: Continuous epidural infusion (CEI)Active Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Giorgio Veneziano

Lead Sponsor

Trials
2
Recruited
300+

Citations

A Randomized, Triple-Blind, Noninferiority Study

Data from the current study provide insufficient evidence to confirm that CP is noninferior to LEBF for rapid epidural extension anesthesia for CD, and further ...

Chloroprocaine Lavage to Improve Outcomes Related to ...

In this case series, the technique of chloroprocaine lavage helped investigators to avoid general endotracheal anesthesia in 32 women having a ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/25819374/

Continuous local anesthetic infusion for children with spina ...

Conclusions: Continuous local anesthetic catheters are a simple, effective alternative strategy to provide postoperative analgesia while ...

Comparison of Chloroprocaine vs Lidocaine for Epidural ...

It was found that the chloroprocaine group had a significantly faster onset of anesthesia compared to the lidocaine group. Both drugs provided ...

Postoperative Analgesia in Neonates and Infants Using ...

These studies have demonstrated effective analgesia with acceptable pain scores and limitation of postoperative opioid needs with the use of a ...

Comparative Evaluation of Ropivacaine for Caudal ...

Conclusion Ropivacaine provides safe, effective, and stable postoperative analgesia comparable to bupivacaine and levobupivacaine in pediatric lower abdominal ...

The Efficacy and Safety of Chloroprocaine 1% and 2% in ...

A total of 174 (87 per treatment group, allocated to 1% or 2% arm in a ratio of 1:1) male and female paediatric patients (age range from birth to <18 years) ...

The safety of continuous epidural infusion for postoperative ...

It is concluded that epidural analgesia is as safe and effective after spinal-deformity surgery as it is after other types of surgery. Epidural analgesia ...

Chloroprocaine 1% Versus Ropivacaine 0,75% During ...

This will be a prospective randomized study, aiming at comparing an intrathecal fixed dose of chloroprocaine 1% versus an intrathecal fixed ...