Objectives:Understanding the effect of opium addiction on the clinical practice is becoming a necessity due to the high prevalence.
Design:Double Blinded Clinical Trial
Setting and Conduct: Dr. Shariati Hospital Operating Room
Participants:120 patients,aged 18-60 years old who are candidate for upperlimb surgery under supraclavicular block, are selected and are randomized into 4 groups.
Patients with a history of chronic pain or allergies to study drug protocol,and renal or liver disease are excluded from the study.
Intervention:
Group 1, no history of opium addiction,receive 30 milliliters of bupivacaine 0.5%along with 2 milliliters saline as placebo;
Group 2, No history of opium addiction, receive 30 milliliters bupivacaine 0.5% along with 2 milliliters sufentanil (10 micrograms);
Group 3, Positive history of opium addiction, receive 30 milliliters bupivacaine 0.5% along with 2 milliliters saline as placebo;
Group 4, positive history of opium addictions , receive 30 milliliters of bupivacaine along with 2 milliliters sufentanil (10 micrograms).
Main outcome measures:Onset time and length of sensory and motor blocks are recorded in the 4 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209165140N5
Registration date:2014-03-11, 1392/12/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-03-11, 1392/12/20
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
Vice chancellor for research-Tehran University of Medical Sciences-
Expected recruitment start date
2014-04-01, 1393/01/12
Expected recruitment end date
2014-05-01, 1393/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of adding sufentanil to marcaine solution 0.5% on the onset and duration of supraclavicular nerve block in addict and non addict patients
Public title
Supraclavicular nerve block in addicts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
A body mass index (BMI) less than 30 kilograms per cubic meter;American Society of anesthesiologists physical status class I and II;Elective forearm and arm surgery less than 180 minutes
Exclusion criteria:
Study protocol drug allergy ;Hepatic or renal disease ;An addiction to benzodiazepines or other non opioid substances;Pregnant women ;History of chronic pain
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee, Faculty of medicine of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Faculty of Medicine,Poorsina street ,Keshavarz avenue,
City
Tehran
Postal code
Approval date
2013-03-20, 1391/12/30
Ethics committee reference number
846/13684
Health conditions studied
1
Description of health condition studied
Regional anesthesia
ICD-10 code
R29.8
ICD-10 code description
نشانه ها و علایم نامشخص شامل سیستم عصبی و سیستم عضلانی و استخوانی
Primary outcomes
1
Description
Nerve block Duration
Timepoint
every 15 minutes
Method of measurement
pinprick test
Secondary outcomes
1
Description
Onset of nerve block
Timepoint
every 5 minutes
Method of measurement
pinprick test
Intervention groups
1
Description
Patients in group 1 are administered the mentioned solution below in a single shot in the supraclavicular nerve block for upper limb regional anesthesia.
Group 1, no history of opium addiction,receive 30mL of bupivacaine 0.5%along with 2 mL saline as placebo(control group)
Category
Treatment - Drugs
2
Description
Patients in group 2 are administered the mentioned solution below in a single shot in the supraclavicular nerve block for upper limb regional anesthesia.
Group 2, No history of opium addiction who receive 30mL bupivacaine 0.5% along with 2mL sufentanil (10µg); (intervention)
Category
Treatment - Drugs
3
Description
Patients in group 3 are administered the mentioned solution below in a single shot in the supraclavicular nerve block for upper limb regional anesthesia.
Group 3, Positive history of opium addiction who receive 30mL bupivacaine 0.5% along with 2mL saline as placebo; (intervention)
Category
Treatment - Drugs
4
Description
Patients in group 4 are administered the mentioned solution below in a single shot in the supraclavicular nerve block for upper limb regional anesthesia.
Group 4, positive history of opium addictions who receive 30 mL of bupivacaine along with 2 mL sufentanil (10 µg). (intervention)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati Hospital
Full name of responsible person
Dr. Omid Azimaraghi
Street address
Dr Shariati Hospital, North Kargar Ave ,Amirabad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research-Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhoondzadeh
Street address
Tehran University of Medical Sciences, Poorsina street ,Keshavarz avenue,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research-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
Chief Resident of Anesthesiology , Dr Shariati Hospital
Full name of responsible person
Dr. Omid Azimaraghi
Position
Chief Resident of Anesthesiology
Other areas of specialty/work
Street address
Dr Shariati Hospital, North Kargar Ave ,Amirabad
City
Tehran
Postal code
Phone
+98 21 2206 6194
Fax
Email
o.azimaraghi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Professor of Anesthesiology at Dr. Shariati Hospital
Full name of responsible person
Dr. Ali Movafegh
Position
Professor of anesthesiology
Other areas of specialty/work
Street address
Dr.Shariati Hospital, North Kargr ave, Amir Abad
City
Tehran
Postal code
Phone
+98 21 8820 2397
Fax
Email
movafegh@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dr. Shariati Hospital
Full name of responsible person
Dr. Omid Azimaraghi
Position
Chief resident of Anesthesiology
Other areas of specialty/work
Street address
Dr. Shariati Hospital, North Kargar Ave,Amir Abad,
City
Tehran
Postal code
Phone
+98 21 2206 6194
Fax
Email
o.azimaraghi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)