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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-12-01

Brief Summary

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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.

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Detailed Description

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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

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

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On-Q Group

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

Group Type EXPERIMENTAL

On-Q pump

Intervention Type DEVICE

Type of pain control device used

Epidural Group

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

Group Type ACTIVE_COMPARATOR

Epidural catheter

Intervention Type DEVICE

Type of pain control device used

Interventions

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On-Q pump

Type of pain control device used

Intervention Type DEVICE

Epidural catheter

Type of pain control device used

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No