MedPath

ITM vs QL for Pediatric Open Lower Abdominal Procedures

Phase 4
Terminated
Conditions
Pain Control
Ureteral Reimplantation
Pediatrics
Intrathecal Morphine
Interventions
Drug: Quadratus lumborum block
Registration Number
NCT05506930
Lead Sponsor
Medical University of South Carolina
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
14
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
quadratus lumborum blockQuadratus lumborum blockQuadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
Intrathecal MorphineIntrathecal MorphineIntrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
Primary Outcome Measures
NameTimeMethod
Duration of Analgesia - Pain Score 0-10Up to 24 hours post-op

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.

Duration of Analgesia - MME/kg in First 24 HoursUp to 24 hours post-op

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.

Secondary Outcome Measures
NameTimeMethod
Number of Participants With Side Effects of Each Interventionup to 48 hours post-operative

The secondary endpoint will assess the side effects of each intervention such as nausea and vomiting, and pruritis.

Severity of Side Effects With Each Intervention0-48 hours post-operatively

The secondary endpoint assesses the severity of side effects with each intervention such as nausea and/or vomiting, and pruritus in the patients who experienced a side effect. Parents of participants who experienced the side effects listed rated the severity of them using a Visual Analog Scale from 0-100mm. The higher the score, the worse the side effect.

Patient/Family Satisfactionup to 48 hours post-operative

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).

Total Length of PACU Stay - Minutestime to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)

This endpoint will assess how long the patient's PACU stay was in minutes. The longer the stay, the worse the outcome.

Total Length of Hospital Stay - Length of Stay, Daystime to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)

This endpoint will assess how long the patient's hospital stay was overall in days. The higher the number of days, the worse the outcome.

Trial Locations

Locations (1)

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

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