ITM vs QL for Pediatric Open Lower Abdominal Procedures
- Conditions
- Pain ControlUreteral ReimplantationPediatricsIntrathecal 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
- Ages 12 months to 11 years old
- Undergoing an open lower abdominal procedure
- 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
Group Intervention Description quadratus lumborum block 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). Intrathecal Morphine Intrathecal Morphine Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
- Primary Outcome Measures
Name Time Method Duration of Analgesia - Pain Score 0-10 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 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 Outcome Measures
Name Time Method Number of Participants With Side Effects of Each Intervention up 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 Intervention 0-48 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 Satisfaction up 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 - Minutes time 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, Days time 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