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

Primary Purpose

Postoperative Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
On-Q pump
Epidural catheter
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, on-Q pump, epidural, children

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

On-Q Group

Epidural Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 30, 2018
Last Updated
January 20, 2022
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03496259
Brief Title
On-Q Pump vs Epidural for Postoperative Pain Control in Children
Official Title
On-Q Pump vs Epidural for Postoperative Pain Control in Children Undergoing Oncologic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment, one of investigators left institution.
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, on-Q pump, epidural, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled study
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
On-Q Group
Arm Type
Experimental
Arm Description
Patients in this group will have an On-Q pump placed at the end of the operation
Arm Title
Epidural Group
Arm Type
Active Comparator
Arm Description
Patients in this group will have an epidural catheter placed at the end of the operation
Intervention Type
Device
Intervention Name(s)
On-Q pump
Intervention Description
Type of pain control device used
Intervention Type
Device
Intervention Name(s)
Epidural catheter
Intervention Description
Type of pain control device used
Primary Outcome Measure Information:
Title
Additional narcotic use
Description
Mg of additional narcotics used for 3 post-operative days
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Pain scores
Description
Visual analog scores provided by patients every 4 hours will be collected for 3 post-operative days
Time Frame
3 days
Title
Days to ambulation
Description
The first post-operative day that patients are ambulating outside the room will be noted
Time Frame
0-5 days
Title
Days to initiation of regular diet
Description
The first post-operative day of initiation of a regular diet will be noted
Time Frame
0-5 days
Title
Development of postoperative infection
Description
Infections (such as urinary tract infection, wound infection, or epidural site infection) will be noted
Time Frame
0-5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bindi Naik-Mathuria, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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