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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03496259
• Other study ID #: H-42606
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2022
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: December 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• On-Q pump
Type of pain control device used
• Epidural catheter
Type of pain control device used

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Additional narcotic use	Mg of additional narcotics used for 3 post-operative days	3 days
Secondary	Pain scores	Visual analog scores provided by patients every 4 hours will be collected for 3 post-operative days	3 days
Secondary	Days to ambulation	The first post-operative day that patients are ambulating outside the room will be noted	0-5 days
Secondary	Days to initiation of regular diet	The first post-operative day of initiation of a regular diet will be noted	0-5 days
Secondary	Development of postoperative infection	Infections (such as urinary tract infection, wound infection, or epidural site infection) will be noted	0-5 days