Postoperative PainNCT03496259
On-Q Pump vs Epidural for Postoperative Pain Control in Children
A study testing On-Q pump and Epidural catheter in people with Postoperative Pain, run by Baylor College of Medicine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- On-Q pump and Epidural catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Weight > 5kg
- Age younger than 19 years of age
- Planned abdominal, pelvic or thoracic operation for an oncologic indication
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: On-Q Pump vs Epidural for Postoperative Pain Control in Children Undergoing Oncologic Surgery
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- On-Q pump, Epidural catheter
- Keywords
- Postoperative pain, on-Q pump, epidural, children
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-Q pumpDevice
Type of pain control device used
Epidural catheterDevice
Type of pain control device used
| Study group | Role | What they receive |
|---|---|---|
| On-Q Group | Experimental | Patients in this group will have an On-Q pump placed at the end of the operation Receives: Device: On-Q pump |
| Epidural Group | Active comparator | Patients in this group will have an epidural catheter placed at the end of the operation Receives: Device: Epidural catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Additional narcotic use
Mg of additional narcotics used for 3 post-operative days
Measured: 3 days
Secondary outcomes (4)
Pain scores
Visual analog scores provided by patients every 4 hours will be collected for 3 post-operative days
Measured: 3 days
Days to ambulation
The first post-operative day that patients are ambulating outside the room will be noted
Measured: 0-5 days
Days to initiation of regular diet
The first post-operative day of initiation of a regular diet will be noted
Measured: 0-5 days
Development of postoperative infection
Infections (such as urinary tract infection, wound infection, or epidural site infection) will be noted
Measured: 0-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Sep 2018
- Primary completion1 Jun 2021
- Study completion1 Dec 2021
Why it stopped: Poor recruitment, one of investigators left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bindi Naik-Mathuria, Baylor College of Medicine
- Investigators
- Bindi Naik-Mathuria, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496259
- Sponsor's protocol ID
- H-42606
- Status last verified
- Jan 2022
- First submitted
- 30 Mar 2018
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-Q Pump vs Epidural for Postoperative Pain Control in Children Undergoing Oncologic Surgery
- ClinicalTrials.gov ID
- NCT03496259
- Acronym / sponsor ID
- H-42606
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, on-Q pump, epidural, children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment, one of investigators left institution.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| On-Q Group | Experimental | Device: On-Q pumpPatients in this group will have an On-Q pump placed at the end of the operation |
| Epidural Group | Active comparator | Device: Epidural catheterPatients in this group will have an epidural catheter placed at the end of the operation |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Weight > 5kg
- Age younger than 19 years of age
- Planned abdominal, pelvic or thoracic operation for an oncologic indication
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-Q pumpType of pain control device used | Device | On-Q Group |
| Epidural catheterType of pain control device used | Device | Epidural Group |
Primary outcome
Additional narcotic use
Time frame: 3 days
Mg of additional narcotics used for 3 post-operative days
4 secondary outcomes
Pain scores
Time frame: 3 days
Days to ambulation
Time frame: 0-5 days
Days to initiation of regular diet
Time frame: 0-5 days
Development of postoperative infection
Time frame: 0-5 days
Results and safety
The study was stopped early (reason given: Poor recruitment, one of investigators left institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bindi Naik-Mathuria, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-Q pump and Epidural catheter in people with Postoperative Pain, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment, one of investigators left institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Additional narcotic use (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.