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Surgical Stress Measured by Microdialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01495143
First received: December 29, 2009
Last updated: May 1, 2013
Last verified: May 2013
History of Changes

December 29, 2009
May 1, 2013
January 2007
December 2007   (final data collection date for primary outcome measure)
The glycerol concentration [ Time Frame: Two hours ] [ Designated as safety issue: No ]
To study whether the glucerol concentration can be used to evaluate surgery related paraspinal muscle damage
Same as current
Complete list of historical versions of study NCT01495143 on ClinicalTrials.gov Archive Site
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Surgical Stress Measured by Microdialysis
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).

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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Trauma
Procedure: Posterolateral lumbar fusion surgery
Two MD catheters with 1% lidocaine 1-2 ml are placed in the paraspinal muscle.
Other Name: Lumbar diseases
  • 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.
    Intervention: Procedure: Posterolateral lumbar fusion surgery
  • 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.

    Intervention: Procedure: Posterolateral lumbar fusion surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
June 2008
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01495143
ON-07-012-RAS
No
Northern Orthopaedic Division, Denmark
Northern Orthopaedic Division, Denmark
Not Provided
Principal Investigator: Gang Ren, MD, PhD Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
Northern Orthopaedic Division, Denmark
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP