Evaluation of spinal anaesthesia blockade time with 0.5% bupivacaine-with or without sufentanil-in opium addict patients in comparison with non-addicts: a randomized clinical trial
With the prevalence of illicit opioid use in different regions around the world, understanding the effect of opium addiction on the clinical practice is becoming a necessity. 60 patients, who are candidate for lower limb surgery, are selected from patients referred to Dr. Shariati hospital and are randomized into 4 groups. Patients with a history of chronic pain or allergies are excluded from the study. Group 1, no history of opium addiction who receive intrathecal bupivacaine along with 1 mL saline as placebo; group 2, no history of opium addiction who receive intrathecal bupivacaine along with 1 mL sufentanil (5 µg); group 3, Positive history of opium addiction who receive intrathecal bupivacaine along with 1 mL saline as placebo; and group 4, positive history of opium addictions who receive intrathecal bupivacaine along with 1 mL sufentanil (5 µg). Onset time and lenghth of sensory and motor blocks are recorded in the 4 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012045140N2
Registration date:2012-09-11, 1391/06/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-11, 1391/06/21
Registrant information
Name
Omid Azimaraghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 6194
Email address
cazimaraghi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-04-13, 1388/01/24
Expected recruitment end date
2011-07-19, 1390/04/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of spinal anaesthesia blockade time with 0.5% bupivacaine-with or without sufentanil-in opium addict patients in comparison with non-addicts: a randomized clinical trial
Public title
The effect of opioids on spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA physical status I and II scheduled for orthopedic surgery less than 2 hours. Exclusion criteria: Hepatic or Renal failure; Heart diseases; History of drug allergy; Morbid obesity; History of postoperative nausea and vomiting (PONV); history of motion sickness; Patients with Chronic pains.
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee, Faculty of medicine of Tehran University of Medical Sciences
Street address
Second floor, Faculty of Medicine, Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
381/1388-34
Health conditions studied
1
Description of health condition studied
Regional anesthesia
ICD-10 code
R29.8
ICD-10 code description
unspecified symptoms and signs involving the nervous and musculoskeletal systems
Primary outcomes
1
Description
Block Time
Timepoint
Every 5 minutes
Method of measurement
Pinprick test
Secondary outcomes
1
Description
Post-operative pain
Timepoint
every 4 hours
Method of measurement
Numeric Rating Score(NRS)
Intervention groups
1
Description
group 1, No history of opium addiction who receive intrathecal bupivacaine along with 1 mL saline as placebo.
Category
Placebo
2
Description
group 2, No history of opium addiction who receive intrathecal bupivacaine along with 1 mL sufentanil (5 µg).
Category
Treatment - Drugs
3
Description
group 3, Positive history of opium addictions who receive intrathecal bupivacaine along with 1 mL saline as placebo.
Category
Treatment - Drugs
4
Description
group 4, Positive history of opium addictions who receive intrathecal bupivacaine along with 1 mL sufentanil (5 µg).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhoundzade
Street address
Faculty of Medicine, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Department of Anesthesiology, Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Movafegh
Position
Assocciate Prof.
Other areas of specialty/work
Street address
Department of Anesthesiology,Tehran University of medical sciences
City
Tehran
Postal code
Phone
+98 21 8490 2372
Fax
Email
movafegh@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiology,Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Movafegh
Position
Assocciate Prof.
Other areas of specialty/work
Street address
Dr.Ali Shariati Hospital, North Karegar St.
City
Tehran
Postal code
Phone
+98 21 8490 2372
Fax
Email
movafegh@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Anesthesiology, Tehran University of Medical Sciences
Full name of responsible person
Omid Azimaraghi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)