Post Operative Pain Control After Pediatric Hip Surgery

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Seattle Children's Healthcare System

Status

Terminated

Conditions

Hip Surgery
Post Operative Pain Control

Treatments

Drug: Ondansetron
Procedure: Lumbar Plexus Catheter
Procedure: Patient Controlled Analgesia
Drug: Acetaminophen
Drug: Morphine
Drug: Fentanyl
Drug: Lorazepam
Drug: Oxycodone
Drug: Diphenhydramine
Procedure: Lumbar Epidural Catheter
Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03435692
13144

Details and patient eligibility

About

Hip surgery in children is painful and the optimal modality for managing post-operative pain has not been established. This prospective randomized controlled trail compares lumbar plexus catheter (LPC), lumbar epidural catheter (LEC) and continuous patient-controlled analgesia (PCA) with intravenous morphine.

Full description

Approximately 1 in 1,000 children born in the US have hip dislocation and 10 in 1,000 have hip subluxation requiring surgical intervention. Pain after major hip surgery in children is severe, yet there is no agreement on the most effective method for pain control. Post-operative pain modalities including lumbar epidural catheters (LEC), lumbar plexus catheters (LPC) and intravenous patient controlled analgesia (IV-PCA) have been described. IV-PCA has historically been the standard of care in spite of its numerous associated side effects. Regional anesthesia modalities have gained popularity because of superior pain control with lower opioid requirements. In this study, the investigators describe the first prospective randomized controlled trial comparing lumbar plexus catheter to alternatives for post-operative pain management in children after major hip surgery. The investigators hypothesized that LPC would be as safe and efficacious as LEC and IV-PCA with the added advantage of a decreased length of stay. The investigators primary aim was to compare hospital length of stay. Secondary aim was to compare pain scores, opioid consumption and opioid-related side effects.

Enrollment

42 patients

Sex

All

Ages

1 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Children undergoing unilateral hip surgery, including pelvic innominate osteotomies, proximal femoral osteotomies, and arthrotomies (for open reduction, loose body removal, labral debridement or labral repair).

Exclusion criteria

History of a previous spine surgery, spina bifida, coagulopathy, skin infection, allergies to study medications (i.e. local anesthetics and opioids), patients taking opioids at the time of enrollment and, those having concurrent procedures distal to the hip.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

42 participants in 3 patient groups

Lumbar Plexus Catheter
Experimental group
Description:
Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. An intraoperative pain protocol will dictate if the patient will receive intravenous fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with as needed (PRN) morphine and oxycodone as well as scheduled acetaminophen.
Treatment:
Drug: Ropivacaine
Drug: Diphenhydramine
Drug: Oxycodone
Drug: Lorazepam
Drug: Fentanyl
Drug: Morphine
Drug: Acetaminophen
Procedure: Lumbar Plexus Catheter
Drug: Ondansetron
Lumbar Epidural Catheter
Active Comparator group
Description:
Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. An intraoperative pain protocol will dictate if the patient will receive intravenous fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with as needed (PRN) morphine and oxycodone as well as scheduled acetaminophen.
Treatment:
Drug: Ropivacaine
Procedure: Lumbar Epidural Catheter
Drug: Diphenhydramine
Drug: Oxycodone
Drug: Lorazepam
Drug: Fentanyl
Drug: Morphine
Drug: Acetaminophen
Drug: Ondansetron
Patient Controlled Analgesia
Active Comparator group
Description:
Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control. An intraoperative pain protocol will dictate if the patient will receive intravenous fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with as needed (PRN) morphine and oxycodone as well as scheduled acetaminophen.
Treatment:
Drug: Diphenhydramine
Drug: Oxycodone
Drug: Lorazepam
Drug: Fentanyl
Drug: Morphine
Drug: Acetaminophen
Procedure: Patient Controlled Analgesia
Drug: Ondansetron

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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