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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508066
• Other study ID #: SHCLA-0116
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2007
• Last updated: January 15, 2013
• Start date: May 2007
• Est. completion date: January 2011

Study information

• Verified date: January 2013
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Clinical Diagnosis of Congenital Scoliosis

• Clinical Diagnosis of Idiopathic Scoliosis

• Anticipated Spinal Fusion Surgery

Exclusion Criteria:

• Less than 8 years of age

Related Conditions & MeSH terms

• Scoliosis

Intervention

Drug:
• Bupivacaine
Bupivacaine 0.25 - 0.5% @ 4ml/hr for 72 hours
• Normal Saline
Normal Saline, 4ml/hour for 72 hours.

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children - Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS pain score		72 hours
Secondary	Physical Therapy Progress		Post-op day 1, 2, 3