Intrathecal Morphine Versus Bilateral Quadratus Lumborum Blocks for Perioperative Analgesia in Pediatric Patients Undergoing Open Lower Abdominal Procedures: A Prospective Randomized Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Duration of Analgesia - Pain Score 0-10
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The patient and their parent/guardians will be blinded.
Eligibility Criteria
- Ages
- 12 Months to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intrathecal Morphine
Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
Intervention: Intrathecal Morphine (Drug)
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).
Intervention: Quadratus lumborum block (Drug)
Outcomes
Primary Outcomes
Duration of Analgesia - Pain Score 0-10
Time Frame: Up 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 Hours
Time Frame: Up 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 Outcomes
- 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))
Investigators
Natalie Barnett
Principal Investigator
Medical University of South Carolina