Scoliosis
Conditions
Keywords
Congenital Scoliosis, Idiopathic Scoliosis, Spinal Fusion, Post-Operative Pain Management, Infusion Catheter
Brief summary
The purpose of this study is to evaluate the effects of continuous local anesthetic delivery on the immediate post-op recovery of patients undergoing spinal fusion surgery for congenital or idiopathic scoliosis.
Detailed description
Constant local analgesic infusion is a relatively new modality that provides a constant supply of medication without the need for repeat injections. This method has shown encouraging results with respect to pain levels, narcotic use, faster rehabilitation and shorter hospital stay in patients undergoing laparotomies, iliac crest bone graft harvest, and sternotomies. In addition, there have not been any reported complications when used in these scenarios. We hope to confirm better pain control, less narcotic use (i.e. PCA), fewer narcotic side effects, better response to physical therapy and earlier discharge. Which may be generalized to the spinal surgery patient population as less pain and suffering and a better overall hospital course
Interventions
DRUGBupivacaine
Bupivacaine 0.25 - 0.5% @ 4ml/hr for 72 hours
DRUGNormal Saline
Normal Saline, 4ml/hour for 72 hours.
Sponsors
Shriners Hospitals for Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Clinical Diagnosis of Congenital Scoliosis * Clinical Diagnosis of Idiopathic Scoliosis * Anticipated Spinal Fusion Surgery
Exclusion criteria
* Less than 8 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS pain score | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Physical Therapy Progress | Post-op day 1, 2, 3 |
Countries
United States
Outcome results
None listed