Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery
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|ClinicalTrials.gov Identifier: NCT00508066|
Recruitment Status : Completed
First Posted : July 27, 2007
Last Update Posted : January 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Scoliosis||Drug: Bupivacaine Drug: Normal Saline||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
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.
- VAS pain score [ Time Frame: 72 hours ]
- Physical Therapy Progress [ Time Frame: Post-op day 1, 2, 3 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|