NCT05506930

ITM vs QL for Pediatric Open Lower Abdominal Procedures

Intrathecal Morphine Versus Bilateral Quadratus Lumborum Blocks for Perioperative Analgesia in Pediatric Patients Undergoing Open Lower Abdominal Procedures: A Prospective Randomized Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 12 Months – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain Control
• Ureteral Reimplantation
• Pediatrics
• Intrathecal Morphine

Interventions

Type	Name	Description
DRUG	Intrathecal Morphine	One group of subjects will receive intrathecal morphine: spinal (neuraxial) dose of preservative free morphine (Duramorph), usually about 4-5mcg/kg. This is injected into the cerebrospinal fluid under sterile technique by a pediatric anesthesiologist while the subject is already under general anesthesia. This procedure is well-described in the pediatric population and used regularly for postoperative pain relief for a variety of procedures including ureteral reimplantation.
DRUG	Quadratus lumborum block	The second group of subjects will have bilateral quadratus lumborum blocks: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per/ kg per side (total dose approximately 1mL/kg). This is injected in the subject's flank in the fascial plane between the quadratus lumborum muscle and the psoas muscle. Ultrasound guidance is used for needle and structure localization and this procedure is done by a pediatric anesthesiologist while the subject is already under general anesthesia. Quadratus lumborum blocks are regularly used in clinical practice for postoperative pain relief for a variety of abdominal procedures.

Timeline

• Start date: 2022-08-17
• Primary completion: 2024-05-09
• Completion: 2024-05-10
• First posted: 2022-08-18
• Last updated: 2025-04-15
• Results posted: 2025-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study