Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189781
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-12-13
Brief Title:
Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Peri-operative Use of a Pain Injection Versus Epidural in Pediatric Patients With Cerebral Palsy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 groups 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
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 groups 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
Detailed Description:
Over the past decade there has been an ongoing shift away from the use of opioids in the postoperative setting due to both their negative side effects and their high potential for dependence and abuse Various new techniques for multimodal pain management are increasingly being utilized in adult orthopaedics including injection of local anesthetics and analgesic agents These techniques aim to block pain directly at the site of injection in order to reduce postoperative pain while minimizing systemic effects and preserving motor function allowing for early mobilization Numerous randomized controlled trials in both the arthroplasty and adult trauma populations have demonstrated reduced pain and narcotic consumption with local analgesia injection but there is scant evidence on the efficacy of similar injections in pediatric surgical patients While robust evidence demonstrating both safety and efficacy of these injections has led to routine use in the adult orthopaedic population use in pediatric patients still remains limited likely due to a lack of level I therapeutic evidence
Local anesthetic injections offer several theoretical advantages over current pain management modalities When compared with other methods of anesthesia including epidural anesthesia or some peripheral nerve blocks local anesthetic injections preserve motor function allowing for early mobilization and rehabilitation Additionally they do not require specialized equipment or anesthesia personnel and can be administered in the operating room without significantly affecting the duration of the procedure While a mainstay in traditional pain management protocols epidural anesthesia in the pediatric CP population poses specific risks including damage to preexisting intrathecal baclofen pumps and iatrogenic infection Moreover epidural insertion can be a technically demanding procedure in these patients given high rates of concomitant neuromuscular scoliosis Prior retrospective studies comparing peripheral nerve and lumbar plexus blocks compared to epidural anesthesia have shown mixed results in decreasing pain scores and opioid use in this patient population As described in Preliminary Data section below the investigators pilot randomized control trial demonstrated significantly decreased pain scores and narcotic use postoperatively in pediatric patients with CP who received multimodal analgesia injection compared to placebo while undergoing hip surgery The present study aims to substantively contribute to current literature by providing level I evidence comparing the safety and efficacy of surgical site injections with epidural anesthesia in a patient population for whom pain management remains challenging
Local anesthetic injections offer several theoretical advantages over current pain management modalities When compared with other methods of anesthesia including epidural anesthesia or some peripheral nerve blocks local anesthetic injections preserve motor function allowing for early mobilization and rehabilitation Additionally they do not require specialized equipment or anesthesia personnel and can be administered in the operating room without significantly affecting the duration of the procedure While a mainstay in traditional pain management protocols epidural anesthesia in the pediatric CP population poses specific risks including damage to preexisting intrathecal baclofen pumps and iatrogenic infection Moreover epidural insertion can be a technically demanding procedure in these patients given high rates of concomitant neuromuscular scoliosis Prior retrospective studies comparing peripheral nerve and lumbar plexus blocks compared to epidural anesthesia have shown mixed results in decreasing pain scores and opioid use in this patient population As described in Preliminary Data section below the investigators pilot randomized control trial demonstrated significantly decreased pain scores and narcotic use postoperatively in pediatric patients with CP who received multimodal analgesia injection compared to placebo while undergoing hip surgery The present study aims to substantively contribute to current literature by providing level I evidence comparing the safety and efficacy of surgical site injections with epidural anesthesia in a patient population for whom pain management remains challenging
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None