Aim: Is to evaluate the effectiveness of Intrathecal adenosine in controlling post operative neuropathic pain in one-level lumbar discectomy. Method: A number of 40 patients were admitted to the study after obtaining written consent at Imam Reza Hospital and were studied for a year. Inclusion criteria: all patients aged 20-60 referred from the neurosurgery clinic with radicular pain following a discectomy in one level. Exclusion criteria: Asthma; liver impairment; renal impairment; endocrine disorders; coronary diseases; allergy to Methyl Xanthenes; addiction and psychogenic disorders. At first the scale of Patients pain were recorded using the VAS and subsequently the amount of analgesic dose was noted then patients were admitted to the outpatient ward and hospitalized. After obtaining a solid IV access and making sure the patient is well hydrated using normal saline, in a sitting position with a gauge 25 Quinke needle is inserted into the L4-L5 space and after observing the CSF an amount of 1000 micrograms of Adenosine without any other excipients
was injected into the Intrathecal space. During of the procedure and recovery, routine monitoring was conducted. After making sure there were no sensory, motor, urinary and autonomic dysfunction, a second set of questionnaire was handed out to the patients regarding their pain scale and analgesic consumption in the first , 6th,12th hour ; first, second and third day; first, second and third week. First, second and third month and soon were obtained and recorded using telephone. At last all data, before and after intervention were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608171772N20
Registration date:2016-08-28, 1395/06/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-28, 1395/06/07
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1381 8940
Email address
aghamohammadid@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Unite 2 Vice Chancellor for Research, Faculty of Medicine,Tabriz University of Medical Sciences
Expected recruitment start date
2015-11-10, 1394/08/19
Expected recruitment end date
2016-08-05, 1395/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Intrathecal Adenosine in the control of neuropathic pain after lumbar discectomy in one level
Public title
Intrathecal Adenosine effect for controlling post discectomy neuropathic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria; Patients aged 20-60 referred from the neurosurgery clinic with radicular pain following a discectomy in one level. Exclusion criteria: asthma; liver impairment; renal impairment; endocrine disorders; coronary diseases; allergy to Methyl Xanthenes; addiction and psychogenic disorders
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences University of Medical Sciences
Street address
Daneshghah street . Fuculty of medicine ,Vice Chancellor for Research-Tabriz University of Medical Sciencest- Daneshghah Street Tabriz East Azarbaijan
City
Tabriz
Postal code
Approval date
2015-11-09, 1394/08/18
Ethics committee reference number
TBZMED.REC.1394,781
Health conditions studied
1
Description of health condition studied
Postlaminectomy syndrome, not elsewhere classified
ICD-10 code
M96.1
ICD-10 code description
Postlaminectomy syndrome, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
first , 6th,12th hour ; first,second and third day; first, second and third week. First, second and third month
Method of measurement
visual analog scale
Secondary outcomes
1
Description
Amount of analgesic consumption
Timepoint
first , 6th,12th hour ; first,second and third day; first, second and third week. First, second and third month
Method of measurement
dose
Intervention groups
1
Description
Intrathecal administration of 1000 microgram
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital/Tabriz
Full name of responsible person
Dawood Aghamohammadi
Street address
Imam Reza Hospital, Tabriz University of Medical Sciencest, Daneshghah street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Faculty of Medicine,Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Street address
Unite 2 ,Vice Chancellor for Research,Tabriz University of Medical Sciencest, Daneshghah Street, Tabriz
City
Tabriz
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, Faculty of Medicine,Tabriz 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
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science
Full name of responsible person
Dawood Aghamohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science, Daneshghah street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3381 8940
Fax
Email
daghamohamadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science
Full name of responsible person
Dawood Aghamohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science, Daneshghah street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3381 8940
Fax
Email
daghamohamadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science
Full name of responsible person
Dawood Aghamohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science, Daneshghah street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3381 8940
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)