Determine the effect of Clonidine on pain relief after lumbar disc surgery
Design
Clinical trial with control group, with parallel groups, Triple blind, 60 patients
Settings and conduct
Two engines will be used in place of placebo and in a clinical trial in two parallel groups. During the entire study period, patients, staff and surgeons will be unaware of the two main study arms.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 70 years
Weight 60 to 80 kg
Having satisfaction
Adherence of clinical signs and symptoms to MRI findings
The presence of a disc in a lumbar space in an MRI
Exit criteria:
History of lumbar surgery
Drug Addiction or Alcohol
Pregnancy and lactation
Previous use of the same drugs
Seizures and other neurological diseases
Intervention over a diskette only involves the use of a discectomy or diskette over a disk space
Use of other medications the day before or after surgery (unwanted)
The patient's disability is due to retardation, aphasia, visual impairment, and other things that prevent the patient from communicating.
The patient's over-standard need for opioid and analgesic neuropathic drugs
History of obstructive peripheral vascular disease
Intervention groups
Intervention group: Clonidine capsule form will given to patients.
Control group: Placebo capsule form will given to patients.
Main outcome variables
Post-operative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N11
Registration date:2019-10-20, 1398/07/28
Registration timing:prospective
Last update:2019-10-20, 1398/07/28
Update count:0
Registration date
2019-10-20, 1398/07/28
Registrant information
Name
Firooz Salehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0830
Email address
salehpourf@tbzmed.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2640-01-26, 2018/11/06
Expected recruitment end date
2640-06-27, 2019/04/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Role of clonidine in management of pain after lumbar discectomy
Public title
The effect of medication on reducing lumbar pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 70 years
Weight 60 to 80 kg
Having satisfaction
Adherence of clinical signs and symptoms to MRI findings
The presence of a disc in a lumbar space in an MRI
Exclusion criteria:
History of lumbar surgery
Drug or Alcohol Addiction
Pregnancy and lactation
Previous use of the same drugs
Seizures and other neurological diseases
Intervention over a diskette only involves the use of a discectomy or diskette over a disk space
Use of other medications the day before or after surgery (unwanted)
The patient's disability is due to retardation, aphasia, visual impairment, and other things that prevent the patient from communicating.
The patient's over-standard need for opioid and analgesic neuropathic drugs
History of obstructive peripheral vascular disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into case and control groups. Randomization will be done using the Gaussian command at www.random.org.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Two engines will be used in place of placebo and in a clinical trial in two parallel groups. During the entire study period, patients, staff and surgeons will be unaware of the two main study arms.
The use of Visual Analogue Scale (VAS) will be done to measure pain in the lower limbs and wrists of patients receiving Clonidine and placebo. Clonidine used in the form of capsules and 2 hours before surgical intervention will be given to patients in the study group. Oral Gabapentin begins with a standard dose for the patient. The placebo capsule, taken in the shape and size and color and weight of the actual drug by the head nurse, is considered to be blind to 2 hours before surgery. Two arms of control and case will be mediation by an anesthetic protocol and a profile.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Floor 3, Center building N 2, Tabriz university of medical sciences, Golgasht street.
City
Tabriz
Province
East Azarbaijan
Postal code
04133357310
Approval date
2018-08-27, 1397/06/05
Ethics committee reference number
IR.TBZMED.REC.1397.481
Health conditions studied
1
Description of health condition studied
Post-procedural Pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Post-operative pain
Timepoint
Clonidine used in capsule form and 2 hours before surgical intervention in the case group will be given to patients. After surgery for the first 24 hours and at the end of 6 hours, one physician who is blind to the study will record the parametric / VAS pain rate in the sheet. The amount of Opioid ingestion in the first 24 hours after surgery will also be measured for each patient.
Method of measurement
Using VAS (virtual analogue scale) to measure pain in the lower extremities and wrists of patients receiving clonidine and placebo.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Clonidine produced by Zahravi Tabriz Company will be given orally to the patients in the form of 0.2 mg tablet twice daily.
Category
Treatment - Drugs
2
Description
Control group: Placebo produced by Zahravi Tabriz Company will be given orally to the patients in the form of 0.2 mg tablet twice daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza hospital and Shohada hospital
Full name of responsible person
Javad Aghazadeh
Street address
Golgash street, Tabriz university of medical science.
City
Tabriz
Province
East Azarbaijan
Postal code
5165686713
Phone
+98 41 3334 0830
Email
mahni81@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Joyban
Street address
Headquarters No. 2, Third Floor of Research & Technology Dept. Golgasht Street , Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5165686713
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Aghazade
Position
Neurosurgical Specialist - Neurosurgery
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Tabriz university of medical science
City
Tabriz
Province
East Azarbaijan
Postal code
5165686713
Phone
+98 41 3333 8397
Email
jaghazadeh56@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Aghazade
Position
Neurosurgical Specialist - Neurosurgery
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Tabriz university of medical science
City
Tabriz
Province
East Azarbaijan
Postal code
5165686713
Phone
+98 41 3333 8397
Email
jaghazadeh56@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Aghazade
Position
Neurosurgical Specialist - Neurosurgery
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Tabriz university of medical science
City
Tabriz
Province
East Azarbaijan
Postal code
5165686713
Phone
+98 41 3333 8397
Email
jaghazadeh56@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is available for sharing.
When the data will become available and for how long
Start the access period 3 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Research and Therapeutic Use
From where data/document is obtainable
Resident of neurosurgery at Imam Reza Hospital
09143141602
What processes are involved for a request to access data/document
Three months after publication of results, the writing request were submitted in the Office of the Department of neurosurgery at Imam Reza Hospital in Tabriz and will be contacted with the relevant resident.