Clinical trial NCT03435692
Conditions: Hip Surgery Post Operative Pain Control
Sponsor: Seattle Children's Hospital
Start date: 2011-07-15; Completion date: 2014-07-29
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed 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.

Arms: arm 1: 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. arm 2: 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. arm 3: 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.
Interventions: intervention 1: Lumbar Plexus Catheter intervention 2: Lumbar Epidural Catheter intervention 3: Patient Controlled Analgesia intervention 4: Fentanyl intervention 5: Morphine intervention 6: Lorazepam intervention 7: Ondansetron intervention 8: Diphenhydramine intervention 9: Acetaminophen intervention 10: Oxycodone intervention 11: Ropivacaine
Intervention descriptions: intervention 1: lumbar plexus catheter placed intraoperatively for perioperative pain control intervention 2: lumbar epidural catheter placed intraoperatively for perioperative pain control intervention 3: Patient Controlled Analgesia (PCA) was started post operatively for perioperative pain control intervention 4: Intravenous fentanyl was administered in the operating room for induction of anesthesia. Subsequent doses in the operating room were standardized to be given only for heart rate or blood pressure increases \> 20% above baseline and occurring more than 30 minutes after the block if applicable. intervention 5: In the operating room patients, intravenous morphine was administered if patients had a failed block and standardized to be given only for heart rate or blood pressure increases \> 20% above baseline and after fentanyl had been administered. Intravenous Morphine was also administered in the operating room if the patient was randomized to the Patient Controlled Analgesia (PCA) arm of the study. Post operatively intravenous Morphine was administered as needed for severe pain. intervention 6: Intravenous Lorazepam was administered as needed for muscle spasm post operatively. intervention 7: Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively. intervention 8: Intravenous Diphenhydramine was administered as needed for itching postoperatively. intervention 9: Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours. intervention 10: Oral Oxycodone was administered as needed for breakthrough pain post operatively. intervention 11: Intravenous Ropivacaine was administered as part of the initial bolus after placement of the lumbar epidural or lumbar plexus catheter and then as a continuous infusion post operatively.

Protocol documents: