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

NCT ID: NCT00508066

Last Updated: 2013-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2011-01-31

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

Conditions

Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

Bupivacaine 0.25 - 0.5% @ 4ml/hr for 72 hours

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.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Normal Saline, 4ml/hour for 72 hours.

Interventions

Bupivacaine

Bupivacaine 0.25 - 0.5% @ 4ml/hr for 72 hours

Intervention Type: DRUG

Normal Saline

Normal Saline, 4ml/hour for 72 hours.

Intervention Type: DRUG

Other Intervention Names

Marcaine

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shriners Hospitals for Children

OTHER

Sponsor Role: lead

Responsible Party

Terri Green

Clinical Data Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norman Otsuka, MD

Role: STUDY_DIRECTOR

Shriners Hospitals for Children - Los Angeles

Anthony Scaduto, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospitals for Children - Los Angeles

Locations

Shriners Hospitals for Children - Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

SHCLA-0116

Identifier Type: -

Identifier Source: org_study_id