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

NCT03496259 | Terminated DMC

• 1 other identifier: H-42606
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Postoperative pain, on-Q pump, epidural, children

Outcome Measures

Primary Outcomes (1)

• Additional narcotic use

  Mg of additional narcotics used for 3 post-operative days

  3 days

Secondary Outcomes (4)

• Pain scores

  3 days

• Days to ambulation

  0-5 days

• Days to initiation of regular diet

  0-5 days

• Development of postoperative infection

  0-5 days

Study Arms (2)

On-Q Group

EXPERIMENTAL

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

Device: On-Q pump

Epidural Group

ACTIVE COMPARATOR

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

Device: Epidural catheter

Interventions

On-Q pump DEVICE

Type of pain control device used

On-Q Group

Epidural catheter DEVICE

Type of pain control device used

Epidural Group

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Weight \> 5kg
• Age younger than 19 years of age
• Planned abdominal, pelvic or thoracic operation for an oncologic indication

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77005, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Bindi Naik-Mathuria, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, controlled study

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 12, 2018
• Study Start: September 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)