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

Not Applicable

Terminated

• Conditions: Postoperative Pain
• Interventions: Device: Epidural catheter; Device: On-Q pump

• Registration Number: NCT03496259
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study First Submitted: 2018-03-30
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-12
• Study Start: 2018-09-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural Group	Epidural catheter	Patients in this group will have an epidural catheter placed at the end of the operation
On-Q Group	On-Q pump	Patients in this group will have an On-Q pump placed at the end of the operation

Primary Outcome Measures

Name	Time	Method
Additional narcotic use	3 days	Mg of additional narcotics used for 3 post-operative days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States