Protocol summary

Summary
With the development of regional anesthetic techniques, in addition to reducing the number of cases of general anesthesia, patients were more satisfied with the surgery and the anesthesia techniques. Infra-clavicular regional local anesthesia techniques including low morbidity and a high level of acceptance by patients, is one of the most widely used method, especially in the upper extremity surgery. Both simple and multiple injection techniques were used in different studies eventhough the Superiority of anyone compared to the other is controversial. The aim of this study was to compare single and multiple injection methods in infraclavicular local anesthesia. This study is designed as a randomized controlled double-blinded trial and were performed on two groups of 20 patients who underwent upper extremity surgery In Beast medical Center of Hamedan. Patients, 15-70 years old, were randomly divided into two study groups, and After localizing the axillary artery under an ultrasound Guide, regional anesthesia with lidocaine 1.5%, either posteriorly simple or multiple injections around artery were done. Within 5-15, 30 minutes and one hour after blocks, the amount of pain on a visual analog scale (VAS) in two groups were measured and compared. Also, the procedure time, anesthesia time to complete anesthesia, the number of cases of complete anesthesia, the number of cases that are in need of additional anesthesia, patient and doctor satisfaction conducting the study were been compared in the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012103011326N1
Registration date: 2012-11-19, 1391/08/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-11-19, 1391/08/29
Registrant information
Name
Aireza Gelini Moghaddam
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2269 5853
Email address
agm@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sceinces
Expected recruitment start date
2011-12-21, 1390/09/30
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of single injection with multiple injection in infraclavicular local anesthesia under guide of ulterasonogeraphy in patients undergone upper limp surgery
Public title
The comparison of single injection with multiple injection in local anesthesia in patients undergone upper limp surgery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criterion: 15-70 years old patients undergoing elective surgery in the upper extremities. Exclusion criteria: hypersensitivity to any of the drugs used; concurrent coagulopathy; localized infection at the injection site; systemic infection; the neurological deficit in the lower limbs; pregnancy and BMI>40.
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences Ethics Committee
Street address
Hamedan University of Medical Sciences- Abaas Abad square
City
Hamedan
Postal code
65178518
Approval date
2012-10-20, 1391/07/29
Ethics committee reference number
د-پ-16-35-9-1558

Health conditions studied

1

Description of health condition studied
upper limb injuries
ICD-10 code
T11.9
ICD-10 code description
Injury of arm NOS

Primary outcomes

1

Description
Patient satisfaction of anesthesia
Timepoint
End of procedure
Method of measurement
0-10 scale

2

Description
Painlessness of patients
Timepoint
5, 15, 30 and 60 min after injection
Method of measurement
Visual analog scale

3

Description
Anesthesiologist satisfaction of anesthesia
Timepoint
End of procedure
Method of measurement
0-10 scale

4

Description
Need to addition of ketamine
Timepoint
End of procedure
Method of measurement
yes/no

Secondary outcomes

1

Description
Time of injection procedure
Timepoint
End of injection
Method of measurement
Minute

2

Description
Time to maximum analgesia
Timepoint
End of injection to maximum analgesia
Method of measurement
Minute

Intervention groups

1

Description
Simple injection for infraclavicular regional anasthesia
Category
Treatment - Drugs

2

Description
Multiple injection for infraclavicular regional anasthesia
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Beasat hospital
Full name of responsible person
Dr Alireza Moghadam
Street address
Resalat square. Beasat haopital
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mrs Frahadi - research assistance
Street address
Hamedan- Hamedan University of Medical Sciences- research assistance
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Alireza Galini Moghadam
Position
MD, Anesthesiology resident
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences- Beasat hospital
City
Hamedan
Postal code
Phone
+98 81 1264 0020
Fax
Email
agm@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Alireza Galini Moghadam
Position
MD, Anesthesiology resident
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences- Beasat hospital
City
Hamedan
Postal code
Phone
+98 81 1264 0020
Fax
Email
agm@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Alireza Galini Moghadam
Position
MD, Anesthesiology resident
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences -Beasat hospital
City
Hamedan
Postal code
Phone
+98 81 1264 0020
Fax
Email
homeopathylover@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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