NCT03435692

Post Operative Pain Control After Pediatric Hip Surgery

Post Operative Analgesia After Pediatric Hip Surgery - PCA, Epidural or Lumbar Plexus Catheter: A Prospective Randomized Control Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hip Surgery
• Post Operative Pain Control

Interventions

Type	Name	Description
PROCEDURE	Lumbar Plexus Catheter	lumbar plexus catheter placed intraoperatively for perioperative pain control
PROCEDURE	Lumbar Epidural Catheter	lumbar epidural catheter placed intraoperatively for perioperative pain control
PROCEDURE	Patient Controlled Analgesia	Patient Controlled Analgesia (PCA) was started post operatively for perioperative pain control
DRUG	Fentanyl	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.
DRUG	Morphine	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.
DRUG	Lorazepam	Intravenous Lorazepam was administered as needed for muscle spasm post operatively.
DRUG	Ondansetron	Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.
DRUG	Diphenhydramine	Intravenous Diphenhydramine was administered as needed for itching postoperatively.
DRUG	Acetaminophen	Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours.
DRUG	Oxycodone	Oral Oxycodone was administered as needed for breakthrough pain post operatively.
DRUG	Ropivacaine	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.

Timeline

• Start date: 2011-07-15
• Primary completion: 2014-07-29
• Completion: 2014-07-29
• First posted: 2018-02-19
• Last updated: 2021-11-02
• Results posted: 2021-11-02