Surgical Stress Measured by Microdialysis

Northern Orthopaedic Division, Denmark

Status: Completed

Conditions: Trauma

Treatments: Procedure: Posterolateral lumbar fusion surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01495143

ON-07-012-RAS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Healthy group

Active Comparator group

Description:

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.

Treatment:

Procedure: Posterolateral lumbar fusion surgery

Surgery group

Experimental group

Description:

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.

Treatment:

Procedure: Posterolateral lumbar fusion surgery