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ITM vs QL for Pediatric Open Lower Abdominal Procedures

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status and phase

Terminated
Phase 4

Conditions

Pediatrics
Pain Control
Intrathecal Morphine
Ureteral Reimplantation

Treatments

Drug: Quadratus lumborum block
Drug: Intrathecal Morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT05506930
Pro00121082

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

12 months to 11 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

14 participants in 2 patient groups

Intrathecal Morphine
Active Comparator group
Description:
Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
Treatment:
Drug: Intrathecal Morphine
quadratus lumborum block
Active Comparator group
Description:
Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
Treatment:
Drug: Quadratus lumborum block

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Haley Nitchie, MHA

Data sourced from clinicaltrials.gov

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