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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
Sponsor:
Information provided by (Responsible Party):
Terri Green, Shriners Hospitals for Children

Study Description
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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.

Condition or disease Intervention/treatment Phase
Scoliosis Drug: Bupivacaine Drug: Normal Saline Phase 4

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Bupivacaine
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.


Outcome Measures
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Primary Outcome Measures :
  1. VAS pain score [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Physical Therapy Progress [ Time Frame: Post-op day 1, 2, 3 ]

Eligibility Criteria
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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical Diagnosis of Congenital Scoliosis
  • Clinical Diagnosis of Idiopathic Scoliosis
  • Anticipated Spinal Fusion Surgery

Exclusion Criteria:

  • Less than 8 years of age
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
Shriners Hospitals for Children - Los Angeles
Los Angeles, California, United States, 90020
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
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Study Director: Norman Otsuka, MD Shriners Hospitals for Children - Los Angeles
Principal Investigator: Anthony Scaduto, MD Shriners Hospitals for Children - Los Angeles
More Information
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Responsible Party: Terri Green, Clinical Data Coordinator, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00508066    
Other Study ID Numbers: SHCLA-0116
First Posted: July 27, 2007    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013
Keywords provided by Terri Green, Shriners Hospitals for Children:
Congenital Scoliosis
Idiopathic Scoliosis
Spinal Fusion
Post-Operative Pain Management
Infusion Catheter
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Bupivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents