Post Operative Pain Control After Pediatric Hip Surgery

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)

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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