ITM vs QL for Pediatric Open Lower Abdominal Procedures (NCT05506930) | Clinical Trial Compass
TerminatedPhase 4
ITM vs QL for Pediatric Open Lower Abdominal Procedures
Stopped: The study was stopped early based on the anecdotal evidence from a surgeon who felt one group was experiencing more side effects than the other. Exposing pediatric patients who would be assigned to the inferior arm was difficult to justify ethically.
United States14 participantsStarted 2022-08-17
Plain-language summary
Patients between the ages of 12 months and 11 years who are undergoing an open lower abdominal procedure will be randomized to receive intrathecal morphine, or bilateral quadratus lumborum block. The investigators will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of pain control as demonstrated by charted pain scores and morphine equivalents in the first 48 hours. This study will also assess the side effects of each intervention such as nausea and vomiting, and itching.
Who can participate
Age range
12 Months – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ages 12 months to 11 years old
* Undergoing an open lower abdominal procedure
Exclusion Criteria:
* Allergy to morphine or amide local anesthetics
* Localized rash at site of planned regional anesthetic block
* Bleeding diathesis
* Spinal dysmorphism
* Previous spinal surgery with instrumentation of the lumbar spine
* Inability or unwillingness of parent or legal guardian to give informed consent.
* Prior enrollment and randomization in this study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — do you know why it was stopped, and does that affect whether intrathecal morphine or quadratus lumborum block is considered safe and effective for my child's ureteral reimplantation pain?
2Since this was a Phase 4 trial comparing two real-world pain control approaches, what does current evidence say about which method — intrathecal morphine or the quadratus lumborum block — tends to work better for children having open lower abdominal surgery like this?
3The trial was measuring how much opioid medication kids needed in the first 24 hours after surgery — based on what your team knows so far, which approach tends to reduce opioid use more in children my child's age?
4Because the trial was terminated, the data may be incomplete — is there other completed research you'd recommend I look at to understand the risks and benefits of each pain control option for pediatric open abdominal procedures?
5What pain management approach would you recommend for my child given that this study didn't fully complete, and are there any standard-of-care protocols at your hospital that are based on stronger evidence?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.