Postoperative Pain
Conditions
Keywords
Postoperative pain, on-Q pump, epidural, children
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.
Interventions
DEVICEOn-Q pump
Type of pain control device used
DEVICEEpidural catheter
Type of pain control device used
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The patient, family and clinical care team (nurses, residents, physician assistants) will be blinded, as well as the research team collecting outcomes. The surgeons (including primary investigator) will not be blinded as will be placing the device.
Intervention model description
Randomized, controlled study
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Additional narcotic use | 3 days | Mg of additional narcotics used for 3 post-operative days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | 3 days | Visual analog scores provided by patients every 4 hours will be collected for 3 post-operative days |
| Days to ambulation | 0-5 days | The first post-operative day that patients are ambulating outside the room will be noted |
| Days to initiation of regular diet | 0-5 days | The first post-operative day of initiation of a regular diet will be noted |
| Development of postoperative infection | 0-5 days | Infections (such as urinary tract infection, wound infection, or epidural site infection) will be noted |
Countries
United States
Outcome results
None listed