Clinical trial NCT03496259: 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
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative pain, on-Q pump, epidural, children
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 32
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Additional narcotic use
timeFrame: 3 days
Secondary outcomes:
measure: Pain scores
timeFrame: 3 days
measure: Days to ambulation
timeFrame: 0-5 days
measure: Days to initiation of regular diet
timeFrame: 0-5 days
measure: Development of postoperative infection
timeFrame: 0-5 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Bindi Naik-Mathuria, MD
role: PRINCIPAL_INVESTIGATOR
References: