Clinical Trials Directory

Trials / Terminated

TerminatedNCT03496259

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

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Baylor College of Medicine · Academic / Other
Sex
All
Age
3 Months – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEOn-Q pumpType of pain control device used
DEVICEEpidural catheterType of pain control device used

Timeline

Start date
2018-09-01
Primary completion
2021-06-01
Completion
2021-12-01
First posted
2018-04-12
Last updated
2022-02-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03496259. Inclusion in this directory is not an endorsement.