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

Phase 4

Completed

• Conditions: Scoliosis
• Interventions: Drug: Bupivacaine; Drug: Normal Saline

• Registration Number: NCT00508066
• Lead Sponsor: Shriners Hospitals for Children

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

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-07-25
• Study First Submitted QC: 2007-07-25
• Study First Posted: 2007-07-27
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-15
• Disposition First Submitted QC: 2013-01-15
• Last Update Submitted: 2013-01-15
• Disposition First Posted: 2013-01-25
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Bupivacaine	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 2	Normal Saline	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.

Primary Outcome Measures

Name	Time	Method
VAS pain score	72 hours

Secondary Outcome Measures

Name	Time	Method
Physical Therapy Progress	Post-op day 1, 2, 3

Trial Locations

Locations (1)

Shriners Hospitals for Children - Los Angeles; 🇺🇸 Los Angeles, California, United States