On-Q Pump vs Epidural for Postoperative Pain Control in Children Undergoing Oncologic Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Pain
- Sponsor
- Baylor College of Medicine
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Additional narcotic use
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Bindi Naik-Mathuria
Associate Professor
Baylor College of Medicine
Eligibility Criteria
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
Outcomes
Primary Outcomes
Additional narcotic use
Time Frame: 3 days
Mg of additional narcotics used for 3 post-operative days
Secondary Outcomes
- Pain scores(3 days)
- Days to ambulation(0-5 days)
- Days to initiation of regular diet(0-5 days)
- Development of postoperative infection(0-5 days)