Sixty-eight patients scheduled for elective forearm and arm surgery under ultrasound guided supraclavicular brachial plexus block are randomly allocated to receive 30 mL bupivacaine 0.5% with 3 mL of isotonic saline chloride (C Group, n = 15), 30 mL bupivacaine 0.5% with 2 mL (100 µg) of fentanyl and 1 mL of isotonic saline chloride(F Group, n = 15), 30 mL bupivacaine 0.5%with 2 mL isotonic saline chloride and 100ng (1 mL) naloxone (N Group, n = 15), or 30 mL bupivacaine 0.5%with 2 mL(100 µg) of fentanyl and 100 ng (1 mL) naloxone (N + F Group, n = 15).
The onset and duration of sensory and motor blockade are recorded in the 4 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209175140N6
Registration date:2012-09-25, 1391/07/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-09-25, 1391/07/04
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
2012-10-10, 1391/07/19
Expected recruitment end date
2013-12-01, 1392/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ultra Low Dose Naloxane and/or fentanyl on the onset time and duration of Supraclavicular Block using Bupivacaine 0.5%
Public title
Effect of Naloxane and/or Opioids on Supraclavicular Block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with American Society of Anesthesiologists physical status class I and II. Exclusion Criteria: Hepatic or Renal failure; Heart diseases; history of drug allergy; substance abuse (including opioids and benzodiazepines); morbid obesity; history of postoperative nausea and vomiting (PONV); history of motion sickness; smokers.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
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
Ethics Committee, Faculty of Medicine, Tehran University of Medical Sciences and Health Care
Street address
Faculty of Medicine, Tehran University of Medical Sciences and Health Care
City
Tehran
Postal code
Approval date
2011-08-20, 1390/05/29
Ethics committee reference number
90/74982
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
acute pain
Primary outcomes
1
Description
Sensory block Onset time and duration
Timepoint
Every 5 minutes from supraclavicular block
Method of measurement
measurement of time
2
Description
Motor block onset and duration time
Timepoint
Time from supraclavicular block, every 5 minutes
Method of measurement
measurement of time
Secondary outcomes
1
Description
Pruritus
Timepoint
Time from supraclavicular block, every 5 minutes
Method of measurement
measurement of time
Intervention groups
1
Description
30 mL bupivacaine 0.5% with 3 mL of isotonic saline chloride
Category
Treatment - Drugs
2
Description
30 mL bupivacaine 0.5% with 2 mL (100 µg) of fentanyl and 1 mL of isotonic saline chloride
Category
Treatment - Drugs
3
Description
30 mL bupivacaine 0.5%with 2 mL isotonic saline chloride and 100ng (1 mL) naloxone
Category
Treatment - Drugs
4
Description
30 mL bupivacaine 0.5%with 2 mL(100 µg) of fentanyl and 100 ng (1 mL) naloxone
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
Dr. Shahin Akhoondzadeh
Street address
Tehran University of Medical Sciences and Health Services
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
Dr. Shariati Hospital
Full name of responsible person
Dr. Ali Movafegh
Position
Professor
Other areas of specialty/work
Street address
Kargar ave, Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8809 1214
Fax
Email
movafegh@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dr. Shariati Hospital
Full name of responsible person
Dr.Ali Movafegh
Position
Professor
Other areas of specialty/work
Street address
North Kargar Ave,Dr. Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8801 2397
Fax
Email
movafegh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Omid Azimaraghi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)