Surgical Stress Measured by Microdialysis

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495143
• Other study ID #: ON-07-012-RAS
• Status: Completed
• Phase: N/A
• First received: December 29, 2009
• Last updated: September 12, 2014
• Start date: January 2007
• Est. completion date: June 2008

Study information

• Verified date: September 2014
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trauma

Intervention

Procedure:
• Posterolateral lumbar fusion surgery
Two MD catheters with 1% lidocaine 1-2 ml are placed in the paraspinal muscle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The glycerol concentration	To study whether the glucerol concentration can be used to evaluate surgery related paraspinal muscle damage	Two hours	No