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

January 15, 2013 updated by: Terri Green, Shriners Hospitals for Children
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90020
        • Shriners Hospitals for Children - Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Less than 8 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS pain score
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Physical Therapy Progress
Time Frame: Post-op day 1, 2, 3
Post-op day 1, 2, 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shriners Hospitals for Children

Investigators

  • Study Director: Norman Otsuka, MD, Shriners Hospitals for Children - Los Angeles
  • Principal Investigator: Anthony Scaduto, MD, Shriners Hospitals for Children - Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

July 25, 2007

First Submitted That Met QC Criteria

July 25, 2007

First Posted (Estimate)

July 27, 2007

Study Record Updates

Last Update Posted (Estimate)

January 25, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHCLA-0116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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