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

Sponsor

Baylor College of Medicine (Other)

Overall Status

Terminated

CT.gov ID

NCT03496259

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Device: On-Q pump Device: Epidural catheter	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, controlled studyRandomized, controlled study

Masking:

Triple (Participant, Care Provider, 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2018

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Additional narcotic use [3 days]
Mg of additional narcotics used for 3 post-operative days

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Children's Hospital	Houston	Texas	United States	77005

Sponsors and Collaborators

Baylor College of Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bindi Naik-Mathuria, Associate Professor, Baylor College of Medicine

ClinicalTrials.gov Identifier:

NCT03496259

Other Study ID Numbers:

H-42606

First Posted:

Apr 12, 2018

Last Update Posted:

Feb 3, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bindi Naik-Mathuria, Associate Professor, Baylor College of Medicine

Postoperative pain, on-Q pump, epidural, children

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Feb 3, 2022