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

Baylor College of Medicine

Status: Terminated

Conditions: Postoperative Pain

Treatments: Device: Epidural catheter; Device: On-Q pump

Study type: Interventional

Funder types: Other

Identifiers

NCT03496259

H-42606

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

32 participants in 2 patient groups

On-Q Group

Experimental group

Description:

Patients in this group will have an On-Q pump placed at the end of the operation

Treatment:

Device: On-Q pump

Epidural Group

Active Comparator group

Description:

Patients in this group will have an epidural catheter placed at the end of the operation

Treatment:

Device: Epidural catheter