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OpenTrials
Completed

NCT Number: NCT01495143

Surgical Stress Measured by Microdialysis

Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery. Minimal invasive surgery is postulated to result in less muscle damage and better outcome. The aim of this study is to monitor metabolic changes of the paraspinal muscle and to evaluate paraspinal muscle damage during surgery using microdialysis (MD).

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Key information

Conditions

Trauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Posterior approach is a common and important surgical procedure for various lumbar diseases. Owing to the anatomy, the damage of paraspinal muscle is inevitable during conventional posterior lumbar fusion surgery. Degeneration and malfunction of the paraspinal muscle might associate with pain and inferior postoperative clinical outcome.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients who undergo conventional instrumented posterolateral lumbar fusion.

Exclusion criteria

  • previous fusion
  • chronic metabolic disease
  • tumor or metastasis
  • postoperative surgical complications and complications during surgery

Treatment and study plan

Posterolateral lumbar fusion surgery

Procedure

Two MD catheters with 1% lidocaine 1-2 ml are placed in the paraspinal muscle.

Other names: Lumbar diseases

Primary outcomes

  1. The glycerol concentration

    Time frame: Two hours

    To study whether the glucerol concentration can be used to evaluate surgery related paraspinal muscle damage

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Registry information

Official study title

Microdialysis of Paraspinal Muscle in Healthy Volunteers and Patients Underwent Posterior Lumbar Fusion Surgery

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Dec 19, 2011
Registry last updated
Sep 15, 2014

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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