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Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery

Primary Purpose

Scoliosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Normal Saline
Sponsored by
Shriners Hospitals for Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring Congenital Scoliosis, Idiopathic Scoliosis, Spinal Fusion, Post-Operative Pain Management, Infusion Catheter

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Less than 8 years of age

Sites / Locations

  • Shriners Hospitals for Children - Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

VAS pain score

Secondary Outcome Measures

Physical Therapy Progress

Full Information

First Posted
July 25, 2007
Last Updated
January 15, 2013
Sponsor
Shriners Hospitals for Children
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1. Study Identification

Unique Protocol Identification Number
NCT00508066
Brief Title
Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery
Official Title
Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shriners Hospitals for Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
Congenital Scoliosis, Idiopathic Scoliosis, Spinal Fusion, Post-Operative Pain Management, Infusion Catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Bupivacaine 0.25 - 0.5% @ 4ml/hr for 72 hours
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Normal Saline, 4ml/hour for 72 hours.
Primary Outcome Measure Information:
Title
VAS pain score
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Physical Therapy Progress
Time Frame
Post-op day 1, 2, 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman Otsuka, MD
Organizational Affiliation
Shriners Hospitals for Children - Los Angeles
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anthony Scaduto, MD
Organizational Affiliation
Shriners Hospitals for Children - Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospitals for Children - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90020
Country
United States

12. IPD Sharing Statement

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Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery

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