A comparison between intravenous regional anesthesia and spinal block efficacy in the foot surgery
Design
A randomized clinical trial with parallel groups. 60 patients have randomly divided into intervention groups A and B with a table of random numbers and Randomizer software.
Settings and conduct
The population of this study was aged 15-70 years old who referred to Ayatollah Rouhani Hospital in Babol. Patients are randomly divided into two Intervention groups (A and B) with a Table of random numbers by computer. All patients would receive the same premedication (200 ml of normal saline, 1 mg of midazolam and 50 micrograms fentanyl).
Intervention group A: The Intravenous regional anesthesia with 200 mg lidocaine diluted with normal saline (40 ml) and Intervention group B: The spinal anesthesia in the sitting position with Marcaine 0.5% at 12 mg
Participants/Inclusion and exclusion criteria
Inclusion criteria: 15 to 70-year-old patients ASA class 1,2
Exclusion criteria: Emergency patients, vascular dysfunction and chronic diabetes
Intervention groups
Intervention group A: The intravenous regional anesthesia with 200 mg lidocaine diluted with normal saline (40 ml).
Intervention group B: The spinal anesthesia in the sitting position with Marcaine 0.5% at 12 mg
Main outcome variables
Anesthesia quality, the onset of local anesthetic effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101013004923N8
Registration date:2019-02-22, 1397/12/03
Registration timing:registered_while_recruiting
Last update:2019-02-22, 1397/12/03
Update count:0
Registration date
2019-02-22, 1397/12/03
Registrant information
Name
Bahman Hasannasab
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
bahmanh2002@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between intravenous regional anesthesia and spinal block efficacy in foot surgery
Public title
Intravenous regional anesthesia and spinal block efficacy in foot surgery
Patients are randomly divided into two intervention A and B groups with a table of random numbers (a random number table is a collection of numbers that are generated without a specific pattern or order and completely randomized), then samples are randomly selected by Randomizer software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Approval date
2018-12-16, 1397/09/25
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.239
Health conditions studied
1
Description of health condition studied
Local anaesthetics
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
Onset of analgesia
Timepoint
Every 5 minutes after start of anesthetics injection
Method of measurement
Evaluate the patients response to needle hitting on surgical site
Secondary outcomes
1
Description
Postoperative Pain
Timepoint
1, 6, 12, 24 Hours after operation
Method of measurement
Visual Analog Scale
2
Description
Overall analgesic requirement post operative
Timepoint
In the first 24 hours after operation
Method of measurement
Nursing Report
Intervention groups
1
Description
Intervention group: All patients would receive the same premedication (200 ml of normal saline, 1 mg of midazolam and 50 micrograms fentanyl). intravenous regional anesthesia with 200 mg lidocaine diluted with normal saline (40 ml) would be done.
Category
Treatment - Drugs
2
Description
Intervention group: All patients would receive the same premedication (200 ml of normal saline, 1 mg of midazolam and 50 micrograms fentanyl). The spinal anesthesia in the sitting position with Marcaine 0.5% at 12 mg would be done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Bahman Hassannasab
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3223 8301
Email
bahmanh2002@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 9595
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?