The aim of this study is to evaluate the paraspinal muscle dissection safe method. This study is double-blind interventional study. Every patient is both case and control. Inclusion criteria: Patients with a fractured spine who are candidate for posterior segmental fixation surgery. Exclusion criteria: Lack of consent to participate in the study; Patients with neurological deficit before surgery; Hemodynamic instability and etc.
interventions of the study are Paraspinal muscle dissection with Monopolar Electrocautery in right side and Paraspinal muscle dissection with a Scalpel in left side. The main outcome variable is F-wave latency in preoperation and postoperation over the three lower extremity nerves (Femoral nerve, Tibial nerve and Peroneal nerve).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041233383N1
Registration date:2017-06-17, 1396/03/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-17, 1396/03/27
Registrant information
Name
Keramat Saeidi
Name of organization / entity
Neurosurgery resident
Country
Iran (Islamic Republic of)
Phone
+98 86 3277 7502
Email address
a.nazemirafie@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Monopolar Electrocautery versus Scalpel on paraspinal muscle dissections: The effect on electrodiagnostic study
Public title
Effect of Monopolar Electrocautery versus Scalpel
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with a fractured spine who candidates for posterior segmental fixation surgery.
Exclusion criteria: Lack of consent to participate in the study; Patients with significant preoperative paresis; Patients in need of laminectomy, foraminotomy or obvious distraction; Unstable conditions and non-cooperative patients( Critically ill, Incomplete consciousness); Vertebral fractures outside the scope of T10 to S1.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Arak University of Medical Sciences
Street address
Ethics Committee , Arak University of Medical Sciences , Aalam al-Hoda St , Shahid Shirodi Ave , Arak , Iran
City
Arak
Postal code
3819693345
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
9317420
Health conditions studied
1
Description of health condition studied
Fractured spine candidates for posterior segmental fixation surgery
ICD-10 code
G54.3; G54
ICD-10 code description
Thoracic root disorders, Not elsewhere classified; Lumbosacral root disorders, Not elsewhere classified
Primary outcomes
1
Description
Nerve Conduction Velocity( F-wave latency)
Timepoint
Before surgery; One day after surgery
Method of measurement
F-wave latency time in milliseconds by an Electromyogram
Secondary outcomes
1
Description
Neurologic deficit
Timepoint
Before surgery; One day after surgery
Method of measurement
Physical examination: Sensory; Motor; Sphincter
Intervention groups
1
Description
The right side paraspinal muscles cut with Monopolar Electrocautery.
Category
Treatment - Surgery
2
Description
The left side paraspinal muscles cut with Scalpel.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Neurosurgery Valiasr Hospital, Arak
Full name of responsible person
Keramat Saeidi
Street address
Valiasr Hospital , Valiasr Sq, Arak , Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Ali Arash Anooshirvani
Street address
Vice President of Research , Arak University of Medical Sciences , Aalam al-Hoda St , Shahid Shirodi Ave , Arak , Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Neurosurgery resident of Arak University of Medical Sciences
Full name of responsible person
Keramat Saeidi
Position
Neurosurgery resident
Other areas of specialty/work
Street address
Valiasr Hospital , Valiasr Sq, Arak , Iran
City
Arak
Postal code
3816148185
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
ka017sam@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Ali Nazemi Rafie
Position
Associate Professor, Department of Neurosurgery
Other areas of specialty/work
Street address
Valiasr Hospital , Valiasr Sq, Arak , Iran
City
Arak
Postal code
Phone
+98 86 3222 2005
Fax
Email
nazemirafie.ali@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Neurosurgery resident of Arak University of Medical Sciences
Full name of responsible person
Keramat Saeidi
Position
Neurosurgery resident
Other areas of specialty/work
Street address
Valiasr Hospital , Valiasr Sq, Arak , Iran
City
Arak
Postal code
Phone
Fax
Email
ka017sam@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)