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

Shriners Hospitals for Children

Status and phase: Completed; Phase 4

Conditions: Scoliosis

Treatments: Drug: Bupivacaine; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00508066

SHCLA-0116

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Description:

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.

Treatment:

Drug: Bupivacaine

Arm 2

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal Saline