Surgical Stress Measured by Microdialysis

NCT ID: NCT01495143

Last Updated: 2014-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-06-30

Brief 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).

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.

Conditions

Trauma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Posterolateral lumbar fusion surgery

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Posterolateral lumbar fusion surgery

Intervention Type: PROCEDURE

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

Interventions

Posterolateral lumbar fusion surgery

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

Intervention Type: PROCEDURE

Other Intervention Names

Lumbar diseases

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gang Ren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

Other Identifiers

ON-07-012-RAS

Identifier Type: -

Identifier Source: org_study_id