ITM vs QL for Pediatric Open Lower Abdominal Procedures

Study Overview
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Brief Summary
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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.

Official Title
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Intrathecal Morphine Versus Bilateral Quadratus Lumborum Blocks for Perioperative Analgesia in Pediatric Patients Undergoing Open Lower Abdominal Procedures: A Prospective Randomized Trial

Conditions
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Pain Control, Ureteral Reimplantation, Pediatrics, Intrathecal Morphine

Intervention / Treatment
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* Drug: Intrathecal Morphine
* Drug: Quadratus lumborum block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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) |