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

Sponsor

Shriners Hospitals for Children (Other)

Overall Status

Completed

CT.gov ID

NCT00508066

Collaborator

(none)

Enrollment

Location

Arms

44.1

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Scoliosis	Drug: Bupivacaine Drug: Normal Saline	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

VAS pain score [72 hours]

Secondary Outcome Measures

Physical Therapy Progress [Post-op day 1, 2, 3]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shriners Hospitals for Children - Los Angeles	Los Angeles	California	United States	90020

Sponsors and Collaborators

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