Effect of minocycline on postoperative pain after lumbar discectomy
Design
Two arm parallel group randomized trial with blinded postoperative care and outcome assessment; with parallel groups and 40 patients in intervention group and 40 patients in control group.
Settings and conduct
In two different surgical centers of Imam Reza hospital and Tabriz shohada hospital, blindness was performed only on patients using placebo, and staff and surgeons, mediators and analyzers, etc. will be unaware of the two main arms of the study. Intervention was minocyclin tablet and placebo.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: Age over 18 and under 70 years, Weight between 60 and 80 kilograms, Adaptation of symptoms and clinical signs with MRI findings.
Exit criteria: History of previous lumbar surgery, Breastfeeding and pregnancy, Decisions to increase the scope of the surgery field,Alcoholism or drug abuse.
Intervention groups
The intervention group will receive the main drug and the placebo control group. The dosage will be 4 doses. A tablet will be given one day before the surgery, one tablet before surgery and one tablet after surgery procedure, and one tablet one day after the procedure. The minosylcine drug will be taken in the form of a 50-mg tablet of the Hexal company.
Main outcome variables
Lumbar pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N2
Registration date:2018-08-18, 1397/05/27
Registration timing:registered_while_recruiting
Last update:2018-08-18, 1397/05/27
Update count:0
Registration date
2018-08-18, 1397/05/27
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
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of minocycline on postoperative pain after lumbar discectomy
Public title
Evaluation the effect of minocycline in reducing postoperative pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 70 years
Weight between 60 and 80 kilograms
Conformity of clinical signs and symptoms with MRI findings
ُSigned informed consent
Exclusion criteria:
Previous lumbar surgery
History of alcohol or drug addiction
Morphine complications during examination
Pregnancy
Breast feeding
Decisions to increase the extent of surgery
Use of analgesics over the last 24 hours
Full improvement of neuropathic pain after surgery
The presence of aphasia and visual impairment or illiteracy that prevents communication with the patient.
Lumbar canal stenosis, Listeriosis, Infection, Spinal cord or bone tumors
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Selecting groups is completely random and will be done after matching. Randomization of patients will be done by file number using www.random.org site. On this site, the Gaussian rendumization method was used with normal distribution.
Blinding (investigator's opinion)
Double blinded
Blinding description
The main intervention medication and placebo are both ordered by the HEXAL Company and will be completely alike.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Science
Street address
Tabriz University of Medical Science , Gholghasht street , Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2018-08-06, 1397/05/15
Ethics committee reference number
IR.TBZMED.REC.1397.386
Health conditions studied
1
Description of health condition studied
Lumbar disc discectomy
ICD-10 code
M51.9
ICD-10 code description
Intervertebral disc disorder, unspecified
Primary outcomes
1
Description
Lumbar pain after surgery
Timepoint
After surgery in recovery, one day after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Minocycline tablet (50 mg) in 4 dose: one tablet one day before surgery, one tablet before surgery procedure, one tablet after surgery procedure, one tablet one day after surgery.
Category
Treatment - Surgery
2
Description
Control group: Placebo tablet, (50 mg) in 4 dose: one tablet one day before surgery, one tablet before surgery procedure, one tablet after surgery procedure, one tablet one day after surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurosurgery Ward of Shohada hospital
Full name of responsible person
Sajjad Ghaemi
Street address
Gholshahr Ave, Shahgoli Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5155841692
Phone
+98 41 3389 3336
Fax
+98 41 3389 3337
Email
shohadahospital@tbzmed.ac.ir
Web page address
https://shohadahosp.tbzmed.ac.ir/
2
Recruitment center
Name of recruitment center
Neurosurgery Ward of Emem Reza hospital
Full name of responsible person
Mir Sajjad Ghaemi
Street address
Daneshghah Ave, Pishghadam Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 0754
Fax
+98 41 3334 0754
Email
info@imamreza.tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Shimya
Street address
Vice Chancellor for Research , Faculty of Medicine , Gholghasht Street, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 6923
Fax
+98 41 3337 6923
Email
info@medfac.tbzmed.ac.ir
Web page address
https://medfac.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?