ITM vs QL for Pediatric Open Lower Abdominal Procedures

NCT05506930 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00121082
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Duration of Analgesia - Pain Score 0-10

  The primary endpoint will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of analgesia as demonstrated by charted pain scores in the first 24 hours. Pain scores were collected from the medical record on a scale from 0-10; the higher the score, the worse the outcome/pain. Time points in the 24 hours post op for each patient varied based on nursing care as the data was collected from the medical record.

  Up to 24 hours post-op

• Duration of Analgesia - MME/kg in First 24 Hours

  The primary endpoint will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of analgesia as demonstrated by morphine milligram equivalents (MME)/kg in the first 24 hours. The higher the MME/kg, the worse the pain.

  Up to 24 hours post-op

Secondary Outcomes (5)

• Number of Participants With Side Effects of Each Intervention

  up to 48 hours post-operative

• Severity of Side Effects With Each Intervention

  0-48 hours post-operatively

• Patient/Family Satisfaction

  up to 48 hours post-operative

• Total Length of PACU Stay - Minutes

  time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)

• Total Length of Hospital Stay - Length of Stay, Days

  time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)

Study Arms (2)

Intrathecal Morphine

ACTIVE COMPARATOR

Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg

Drug: Intrathecal Morphine

quadratus lumborum block

ACTIVE COMPARATOR

Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).

Drug: Quadratus lumborum block

Interventions

Intrathecal Morphine DRUG

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.

Also known as: ITM

Intrathecal Morphine

Quadratus lumborum block DRUG

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.

Also known as: QL

quadratus lumborum block

Eligibility Criteria

• Age: 12 Months - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 12 months to 11 years old
• Undergoing an open lower abdominal procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Natalie Barnett
• Organization: Medical University of South Carolina

barnettn@musc.edu

(843) 792-5454

Study Officials

• Natalie Barnett, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient and their parent/guardians will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 18, 2022
• Study Start: August 17, 2022
• Primary Completion: May 9, 2024
• Study Completion: May 10, 2024
• Last Updated: April 15, 2025
• Results First Posted: April 15, 2025

Record last verified: 2025-04

Locations

US (1)