Your session is about to expire
← Back to Search
Intrathecal Morphine vs Quadratus Lumborum Block for Pediatric Ureteral Reimplantation
Phase 4
Recruiting
Led By Natalie Barnett, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours post-operative
Awards & highlights
Summary
This trial will compare the effects of two methods of pain control on young patients undergoing ureteral reimplantation surgery.
Who is the study for?
This trial is for children aged 12 months to 11 years who are having open lower abdominal surgery, specifically ureteral reimplantation. Kids can't join if they've had spinal surgery with instruments, bleeding issues, allergies to morphine or local anesthetics, skin rash where the block would go, prior belly surgery, or if their parents won't consent.Check my eligibility
What is being tested?
The study compares two pain control methods after belly surgery in kids: intrathecal morphine (ITM) and quadratus lumborum block (QL). It's random which one a child gets. The focus is on how long each method controls pain by looking at pain scores and need for more morphine in the first two days post-surgery.See study design
What are the potential side effects?
Possible side effects include nausea and vomiting as well as itching. These are common reactions when using substances like morphine for pain relief after surgeries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 hours post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 hours post-operative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of analgesia
Secondary outcome measures
Patient/Family Satisfaction
Side effects of each intervention
Total Length of PACU and Hospital Stay
Trial Design
2Treatment groups
Active Control
Group I: Intrathecal MorphineActive Control1 Intervention
Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
Group II: quadratus lumborum blockActive Control1 Intervention
Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
947 Previous Clinical Trials
7,398,038 Total Patients Enrolled
Natalie Barnett, MDPrincipal InvestigatorMedical University of South Carolina
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for an open surgery in my lower abdomen.I have a bleeding disorder.I have a spinal deformity.I am between 1 and 11 years old.I have a rash where I'm supposed to get a regional anesthetic.I have had surgery on my lower back with metal implants.
Research Study Groups:
This trial has the following groups:- Group 1: Intrathecal Morphine
- Group 2: quadratus lumborum block
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger