Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery|
- VAS pain score [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
- Physical Therapy Progress [ Time Frame: Post-op day 1, 2, 3 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Subjects in arm 1 will intraoperatively have a continuous infusion catheter placed in the paraspinal musculature of the posterior spinal wound. Post-operatively, the catheter will infuse 0.25 - 0.5% (according to patient's weight) Bupivacaine at a rate of 4ml/hr for 72 hours. This is in addition to the standardized PCA pain management.
Bupivacaine 0.25 - 0.5% @ 4ml/hr for 72 hours
Other Name: Marcaine
Placebo Comparator: Arm 2
Subjects in arm 2 will intraoperatively have a continuous infusion catheter placed in the paraspinal musculature of the posterior spinal wound. Post-operatively, the catheter will infuse normal saline at a rate of 4ml/hr for 72 hours. This is in addition to the standardized PCA pain management.
Drug: Normal Saline
Normal Saline, 4ml/hour for 72 hours.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508066
|United States, California|
|Shriners Hospitals for Children - Los Angeles|
|Los Angeles, California, United States, 90020|
|Study Director:||Norman Otsuka, MD||Shriners Hospitals for Children - Los Angeles|
|Principal Investigator:||Anthony Scaduto, MD||Shriners Hospitals for Children - Los Angeles|