On-Q Pump vs Epidural for Postoperative Pain Control in Children

Study Overview
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Brief Summary
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Open abdominal and pelvic surgery or thoracotomy (open chest surgery) is frequently performed for tumor excision in children. Post-operative pain management regimens are often at the discretions of the attending surgeon and may include opiods, patient administered analgesia (PCA), epidural catheters, subcutaneous analgesia catheters or NSAIDS to control incisional pain. Currently, both epidural or subcutaneous analgesia catheters (On-Q pumps) are commonly used for children undergoing these operations, at the discretion of the surgeon. There are no studies comparing these regimens in children. The purpose of this study is to compare postoperative pain control of the two strategies.

Detailed Description
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The study design is a randomized, controlled trial to compare the effectiveness of on-q pump subcutaneous incisional analgesia to epidural analgesia for postoperative pain relief in children undergoing open abdominal, thoracic, or pelvic operations for oncologic purposes. The patient and treating team will be blinded to the pain control device. The primary outcome is additional narcotic usage for 3 post-operative days, and secondary outcomes are pain scores for 3 post-operative days, post-surgical day of ambulation, time to regular diet, infectious complications (UTI, wound infection or pneumonia), and hospital length of stay. Outcomes from both groups will be directly compared in order to determine whether one strategy provides more effective pain control with less complications than the other, or whether they are equivalent.

Official Title
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On-Q Pump vs Epidural for Postoperative Pain Control in Children Undergoing Oncologic Surgery

Conditions
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Postoperative Pain

Intervention / Treatment
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* Device: On-Q pump
* Device: Epidural catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Weight > 5kg Age younger than 19 years of age Planned abdominal, pelvic or thoracic operation for an oncologic indication Exclusion Criteria: Patients deemed inappropriate for placement of epidural by anesthesiologist Minimally invasive operation Biopsy through limited incision History of chronic narcotic or opioid use History of drug abuse

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Randomized, controlled study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: On-Q Group<br>Patients in this group will have an On-Q pump placed at the end of the operation | Device: On-Q pump<br>* Type of pain control device used<br>|
| Active Comparator: Epidural Group<br>Patients in this group will have an epidural catheter placed at the end of the operation | Device: Epidural catheter<br>* Type of pain control device used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional narcotic use | Mg of additional narcotics used for 3 post-operative days | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Visual analog scores provided by patients every 4 hours will be collected for 3 post-operative days | 3 days | 
| Days to ambulation | The first post-operative day that patients are ambulating outside the room will be noted | 0-5 days | 
| Days to initiation of regular diet | The first post-operative day of initiation of a regular diet will be noted | 0-5 days | 
| Development of postoperative infection | Infections (such as urinary tract infection, wound infection, or epidural site infection) will be noted | 0-5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, on-Q pump, epidural, children