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| Name | Class |
|---|---|
| Pacira Pharmaceuticals, Inc | INDUSTRY |
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The goal of this pilot study is to assess the feasibility of conducting a randomized controlled trial at a single institution comparing erector spinae plane blockade (ESPB) with liposomal bupivacaine (LB, Exparel) to intravenous (IV) methadone for managing pain in pediatric subjects undergoing adolescent and juvenile idiopathic scoliosis correction. Specifically, the goal is to enroll 15 subjects in each group and to complete data collection for all subjects. If this pilot study is successful, we plan to then design a larger scale study powered to compare specific outcomes between the two groups.
Enrolled subjects will be randomized to one of two groups: one group will receive intra-operative IV methadone as the primary means of controlling post-operative pain while the other group will instead receive intra-operative erector spinae plane blocks (ESPB) with liposomal bupivacaine (LB, Exparel) and bupivacaine hydrochloride as the primary means of controlling postoperative pain. All other aspects of peri-operative management will be standardized. Subjects and the post-operative care team will be blinded to which intervention was performed in order to reduce bias. Upon discharge, subjects will receive a wearable activity monitor and a daily journal in order to record post-discharge data. Subjects will receive weekly phone calls for data collection and then will have a final in-person clinic visit, at which point participation in the study will conclude.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous (IV) Methadone | Active Comparator | Subjects will receive IV methadone 0.2 mg/kg (maximum dose 20mg) via an infusion pump over 15 minutes while undergoing continuous monitoring. Additional IV methadone may be given during the case per the anesthesiologist's discretion, but the total dose may not exceed 20mg. |
|
| Liposomal Bupivacaine (LB, Exparel) | Experimental | Subjects will receive four-point ESPB with an admixture of LB and 0.25% bupivacaine hydrochloride. The total LB dose will be 4mg/kg, max dose of 266mg, while the total dose of bupivacaine hydrochloride will be 2mg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | IV Methadone |
| |
| Liposomal bupivacaine (LB, Exparel) |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Enrollment and Data Collection of 30 Subjects | Assess the feasibility of completing a prospective randomized trial pilot study comparing Erector Spinae Plane Blockade (ESPB) with liposomal bupivacaine (LB) to intravenous methadone at a single institution in two years | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Assess whether there is a difference in post-operative opioid consumption between the two study groups. This will evaluated by converting all long-acting opioids to daily morphine equivalents per unit of weight. | 2 years |
| Pain Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Casey Stondell, MD | Shriners Children's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospitals for Children | Sacramento | California | 95817 | United States |
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| Drug |
LB and bupivacaine hydrochloride via erector spinae plane blocks |
|
Assess whether there is a difference in post-operative pain scores between the two study groups. Visual analog scale (VAS) scores with a minimum of 0 and a maximum of 10 will be used where 0 is no pain and 10 is the worst pain imaginable |
| 2 years |
| Length of Stay | Assess whether there is a difference in hospital length of stay between the two study groups | 2 years |
| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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