Post Operative Pain Control After Pediatric Hip Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hip Surgery, Post Operative Pain Control

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumbar Plexus Catheter<br>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. | Procedure: Lumbar Plexus Catheter<br>* lumbar plexus catheter placed intraoperatively for perioperative pain control<br>* Other names: LPC;Drug: Fentanyl<br>* 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.<br>Drug: Morphine<br>* 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.<br>Drug: Lorazepam<br>* Intravenous Lorazepam was administered as needed for muscle spasm post operatively.<br>* Other names: Ativan;Drug: Ondansetron<br>* Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.<br>* Other names: Zofran;Drug: Diphenhydramine<br>* Intravenous Diphenhydramine was administered as needed for itching postoperatively.<br>* Other names: Benadryl;Drug: Acetaminophen<br>* Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours.<br>* Other names: Tylenol;Drug: Oxycodone<br>* Oral Oxycodone was administered as needed for breakthrough pain post operatively.<br>Drug: Ropivacaine<br>* 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.<br>|
| Active Comparator: Lumbar Epidural Catheter<br>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. | Procedure: Lumbar Epidural Catheter<br>* lumbar epidural catheter placed intraoperatively for perioperative pain control<br>* Other names: LEC;Drug: Fentanyl<br>* 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.<br>Drug: Morphine<br>* 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.<br>Drug: Lorazepam<br>* Intravenous Lorazepam was administered as needed for muscle spasm post operatively.<br>* Other names: Ativan;Drug: Ondansetron<br>* Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.<br>* Other names: Zofran;Drug: Diphenhydramine<br>* Intravenous Diphenhydramine was administered as needed for itching postoperatively.<br>* Other names: Benadryl;Drug: Acetaminophen<br>* Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours.<br>* Other names: Tylenol;Drug: Oxycodone<br>* Oral Oxycodone was administered as needed for breakthrough pain post operatively.<br>Drug: Ropivacaine<br>* 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.<br>|
| Active Comparator: Patient Controlled Analgesia<br>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. | Procedure: Patient Controlled Analgesia<br>* Patient Controlled Analgesia (PCA) was started post operatively for perioperative pain control<br>* Other names: PCA;Drug: Fentanyl<br>* 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.<br>Drug: Morphine<br>* 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.<br>Drug: Lorazepam<br>* Intravenous Lorazepam was administered as needed for muscle spasm post operatively.<br>* Other names: Ativan;Drug: Ondansetron<br>* Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.<br>* Other names: Zofran;Drug: Diphenhydramine<br>* Intravenous Diphenhydramine was administered as needed for itching postoperatively.<br>* Other names: Benadryl;Drug: Acetaminophen<br>* Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours.<br>* Other names: Tylenol;Drug: Oxycodone<br>* Oral Oxycodone was administered as needed for breakthrough pain post operatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of Stay | Total hospital length of stay | Through hospital stay, an average of 2-3 days. | 
| Maximum Pain Score | Mean of Maximum Pain Score POD 0-2 Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC) for children 1-3 years of age, Faces Pain Scale - Revised (FPS-R) for children over age 3 and the Numeric scale (0-10) for children over age 7. minimum value = 0, maximum value 10 (higher score is worse) | Post-Operative Days 0-2 | 
| Total Perioperative Morphine Equivalents | All administered opioids measured as morphine equivalents (mg/kg) | Post-Operative Days 0-2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea | % of patients with nausea | Post-Operative Days 0-2 | 
| Itching | % of patients with itching | Post-Operative Days 0-2 | 
| Muscle Spasm | % of patients w/ muscle spasm | Post-Operative days 0-2 |