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Completed

NCT Number: NCT00508066

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

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.

Completed

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shriners Hospitals for Children - Los Angeles

Los Angeles, California, 90020, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical Diagnosis of Congenital Scoliosis
  • Clinical Diagnosis of Idiopathic Scoliosis
  • Anticipated Spinal Fusion Surgery

Exclusion criteria

  • Less than 8 years of age

Treatment and study plan

Bupivacaine

Drug

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

Other names: Marcaine

normal saline

Drug

Normal Saline, 4ml/hour for 72 hours.

Primary outcomes

  1. VAS pain score

    Time frame: 72 hours

Secondary outcomes

  1. Physical Therapy Progress

    Time frame: Post-op day 1, 2, 3

Sponsors and collaborators

Lead sponsor

Shriners Hospitals for Children

Other

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jul 27, 2007
Registry last updated
Jan 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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