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

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: On-Q pump; Device: Epidural catheter

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77005
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: On-Q Group; Patients in this group will have an On-Q pump placed at the end of the operation	Device: On-Q pump; Type of pain control device used
Active Comparator: Epidural Group; Patients in this group will have an epidural catheter placed at the end of the operation	Device: Epidural catheter; Type of pain control device used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional narcotic use	Mg of additional narcotics used for 3 post-operative days	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Visual analog scores provided by patients every 4 hours will be collected for 3 post-operative days	3 days
Days to ambulation	The first post-operative day that patients are ambulating outside the room will be noted	0-5 days
Days to initiation of regular diet	The first post-operative day of initiation of a regular diet will be noted	0-5 days
Development of postoperative infection	Infections (such as urinary tract infection, wound infection, or epidural site infection) will be noted	0-5 days

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Bindi Naik-Mathuria, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: March 30, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative pain, on-Q pump, epidural, children
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: H-42606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No