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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

Study 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 weeks
Treatment ~ Varies
Follow Up ~up to 48 hours post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 hours post-operative for reporting.

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
933 Previous Clinical Trials
7,394,605 Total Patients Enrolled
Natalie Barnett, MDPrincipal InvestigatorMedical University of South Carolina

Media Library

Intrathecal Morphine Clinical Trial Eligibility Overview. Trial Name: NCT05506930 — Phase 4
Pain Management Research Study Groups: Intrathecal Morphine, quadratus lumborum block
Pain Management Clinical Trial 2023: Intrathecal Morphine Highlights & Side Effects. Trial Name: NCT05506930 — Phase 4
Intrathecal Morphine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05506930 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled slots available for potential participants in this experiment?

"This clinical trial is still enrolling participants, with the initial posting taking place on August 17th 2022 and most recent alterations being made October 14th of that same year."

Answered by AI

Is the eligibility for this research limited to individuals over eighteen years old?

"For this particular clinical trial, the age requirement for participants is between twelve months and eleven years. There are twenty-three trials available to minors and three that cater exclusively to seniors over sixty-five."

Answered by AI

Is it possible to enroll in this experiment?

"In this clinical trial, 30 minors between 12 months and 11 years old undergoing ureteral reimplantation are being sought. To be eligible for participation, patients must meet the age requirement of 1 year to 11 years old."

Answered by AI

How many subjects are taking part in this medical experiment?

"Affirmative. Information from clinicaltrials.gov indicates that this medical experiment, initially advertised on August 17th 2022, is currently seeking out patients to participate. 30 individuals will be accepted across 1 facility for the duration of the trial."

Answered by AI

To what extent does the administration of Intrathecal Morphine pose a safety risk?

"Intrathecal Morphine is already approved, so its safety score was rated at 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
ITM vs QL for Pediatric Open Lower Abdominal Procedures
Natalie Barnett 2022. "ITM vs QL for Pediatric Open Lower Abdominal Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05506930.
~17 spots leftby Jul 2026
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