ITM vs QL for Pediatric Open Lower Abdominal Procedures

RECRUITING

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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.

Conditions:

Pain Control Ureteral Reimplantation Pediatrics Intrathecal Morphine

Study Start (Actual) 2022-08-17

Primary Completion (Estimated) 2026-07-26

Study Completion (Estimated) 2027-02-01

Enrollment (Estimated) 30

Study Type INTERVENTIONAL

Phase PHASE4

Locations:

📍 Charleston, South Carolina, United States

Eligibility Criteria

Description

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

Ages Eligible for Study: 12 Months to 11 Years (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2022-08-12
First Submitted that Met QC Criteria2022-08-17
First Posted2022-08-18

Study Record Updates

Last Update Submitted that Met QC Criteria2023-10-17
Last Update Posted2023-10-19
Last Verified2023-10