Protocol summary

Summary
Goal of study:The goal of this study is evaluation the effect of local methylprednisolone injection during cervical disc surgery on the prevertebral soft tissue swelling from third to seventh vertebrae. Design: This study is a randomized, single blind, clinical trial. Inclusion criteria: Myelopathy or radicular pain due to cervical disc herniation in one or two segments. Exclusion criteria: Cervical disc herniation more than two segments; history of previous surgery in same area; need to corpectomy. Sample size: Forty patients with myelopathy or radicular pain due to cervical disc herniation undergoing operation in two centers Qazvin Shahid Rajaee and Pasteur hospital. Patients by selection colored cards are divided into two equal groups. In interventional group (20 patients), at the end of operation 80 milligrams methylprednisolone is injected into the retropharyngeal and paravertebral muscles. In control group (20 patients) no injection is used. Patients are unaware of the injection or no ninjection of drug. In all patients, lateral neck radiography is performed one day before surgery, two days and ten days after operation later. All radiographs are evaluated by one radiologist. Primary outcome: Prevertebral soft tissue swelling based on the ratio of prevertebral soft tissue thickness to the anteroposterior diameter of vertebral body is calculated on third to seventh cervical vertebrae. Secondary outcome: Postoperative local pain and dysphagia are compared in the second and tenth day after operation in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015072123270N1
Registration date: 2015-10-08, 1394/07/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-08, 1394/07/16
Registrant information
Name
Mohsen Hasani barzi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6005
Email address
smbarzi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2015-08-17, 1394/05/26
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of injection compared to no injection of local methylprednisolone on prevertebral soft tissue swelling during operation in patients with cervical discopathy
Public title
Effect of local corticosteroid injection on prevertebral soft tissue swelling in cervical disc surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with radiculopathy or myelopathy due to cervical disc involving one or two segments. Exclusion criteria: Cervical disc herniation more than two segments; history of previous surgery in same area; need to corpectomy; Herniated disc due to cervical trauma or infection or tumor; underlying diseases such as rheumatoid arthritis; diabetes and chronic heart or renal diseases.
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Qazvin University of Medical Sciences
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
Approval date
2014-06-02, 1393/03/12
Ethics committee reference number
20/11138/د

Health conditions studied

1

Description of health condition studied
Cervical disc
ICD-10 code
M50
ICD-10 code description
Cervical disc disorders

Primary outcomes

1

Description
Prevertebral soft tissue swelling in third to seventh cervical vertebrae
Timepoint
One day before, two days after and ten days after operation
Method of measurement
Measurement by lateral cervical radiography

Secondary outcomes

1

Description
Local pain in operation site
Timepoint
Two days and ten days after operation
Method of measurement
Visual analogue scale

2

Description
Dysphagia
Timepoint
Two days and ten days after operation
Method of measurement
Dysphagia scaling table

Intervention groups

1

Description
Intervention 1: Local injection of 80 milligram methylprednisolone acetate (injectable suspension) produced by caspiantamin factory into the retropharyngeal and prevertebral neck muscles by 5 milliliter syringe with insulin needle following cervical disc surgery
Category
Treatment - Drugs

2

Description
Intervention 2: In this group at the end of operation no injection into the prevertebral and retropharyngeal muscles is used.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaee hospital
Full name of responsible person
Mohsen hasani barzi
Street address
Padegan St, Qazvin, Iran
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Mohsen hasani barzi
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
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 Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Mohsen hasani barzi
Position
Neurosurgeon
Other areas of specialty/work
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
4321102589
Phone
+98 28 3333 6001
Fax
Email
drbarzi2002@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohsen hasani barzi
Position
Neurosurgeon
Other areas of specialty/work
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
4321102589
Phone
+98 28 3333 6001
Fax
Email
drbarzi2002@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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