Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 25, 2007
CompletedFirst Posted
Study publicly available on registry
July 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJanuary 25, 2013
January 1, 2013
3.7 years
July 25, 2007
January 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VAS pain score
72 hours
Secondary Outcomes (1)
Physical Therapy Progress
Post-op day 1, 2, 3
Study Arms (2)
Arm 1
EXPERIMENTALSubjects 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.
Arm 2
PLACEBO COMPARATORSubjects 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.
Interventions
Eligibility Criteria
You may qualify if:
- Clinical Diagnosis of Congenital Scoliosis
- Clinical Diagnosis of Idiopathic Scoliosis
- Anticipated Spinal Fusion Surgery
You may not qualify if:
- Less than 8 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shriners Hospitals for Children - Los Angeles
Los Angeles, California, 90020, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Norman Otsuka, MD
Shriners Hospitals for Children - Los Angeles
- PRINCIPAL INVESTIGATOR
Anthony Scaduto, MD
Shriners Hospitals for Children - Los Angeles
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Data Coordinator
Study Record Dates
First Submitted
July 25, 2007
First Posted
July 27, 2007
Study Start
May 1, 2007
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
January 25, 2013
Record last verified: 2013-01