Surgical Stress Measured by Microdialysis

September 12, 2014 updated by: Northern Orthopaedic Division, Denmark

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy group
Eight healthy volunteers (five males and three females) with a body mass index of 23.8 and without chronic metabolic disease or low back pain. They are all non-smokers and non-medicated.
Procedure: Posterolateral lumbar fusion surgery
Two MD catheters with 1% lidocaine 1-2 ml are placed in the paraspinal muscle.
Other Names:
  • Lumbar diseases
Experimental: Surgery group

Two MD catheters is placed in the paraspinal muscle at the level of midpoint of incision bilaterally.

A reference catheter is placed in the deltoid muscle.
Procedure: Posterolateral lumbar fusion surgery
Two MD catheters with 1% lidocaine 1-2 ml are placed in the paraspinal muscle.
Other Names:
  • Lumbar diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The glycerol concentration
Time Frame: Two hours
To study whether the glucerol concentration can be used to evaluate surgery related paraspinal muscle damage
Two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Investigators

  • Principal Investigator: Gang Ren, MD, PhD, Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

December 29, 2009

First Submitted That Met QC Criteria

December 15, 2011

First Posted (Estimate)

December 19, 2011

Study Record Updates

Last Update Posted (Estimate)

September 15, 2014

Last Update Submitted That Met QC Criteria

September 12, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ON-07-012-RAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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