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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain Control; Pediatrics; Intrathecal Morphine; Ureteral Reimplantation
• Intervention / Treatment: Drug: Intrathecal Morphine; Drug: Quadratus lumborum block

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Haley Nitchie, MHA; Phone Number: 843-792-1869; Email: nitchie@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Principal Investigator: Natalie Barnett, MD
      • Contact: Haley Nitchie, MHA; Phone Number: 843-792-1869; Email: nitchie@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 11 years (Child)
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intrathecal Morphine; Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg	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.; Other Names: ITM
Active Comparator: quadratus lumborum block; 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; 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.; Other Names: QL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analgesia	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 and morphine equivalents in the first 24 hours.	Up to 24 hours post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects of each intervention	The secondary endpoint will assess the side effects of each intervention such as nausea and vomiting, and pruritis.	up to 48 hours post-operative
Patient/Family Satisfaction	This endpoint will assess patient and family overall satisfaction with their child's pain control and experience of their child's post-op recovery. Satisfaction will be rated using VAS 0 (not satisfied) to 100 (completely satisfied).	up to 48 hours post-operative
Total Length of PACU and Hospital Stay	This endpoint will assess how long the patient's PACU stay was in days, and how long their hospital stay overall was, also in days.	time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Natalie Barnett, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Estimated): July 26, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: Pro00121082

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No