The analgesic effect of paracetamol when added to lidocaine for intravenous regional anesthesia
Design
A randomized clinical trial with parallel groups. 60 patients have randomly divided into intervention groups A, B and C with a table of random numbers and Randomizer software.
Settings and conduct
The population of this study was aged 20-60 years old who referred to Ayatollah Rouhani Hospital in Babol. Patients are randomly divided into three Intervention groups with a Table of random numbers by computer.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:20--60 years old, Patients undergoing hand surgeries, ASA ClassI,II
Exclusion Criteria: History of allergic reaction, Addiction, Pregnancy
Intervention groups
Intervention group A: intravenous regional anesthesia with 200 mg lidocaine diluted with normal saline (40 ml) would be done. Also, patients received with peripheral venous catheter 20 ml normal saline.
Intervention group B: All patients would received the same premeditation (200 ml of normal saline, 1 mg of midazolam and 50 micrograms fentanyl).intravenous regional anesthesia with 300 mg parasetamol (40 ml) would be done.Also, patients received with peripheral venous catheter 20 ml normal saline.
Intervention group C: All patients would received the same premeditation (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. Also, patients received with peripheral venous catheter 300 mg of paracetamol (20 ml).
Main outcome variables
Surgical site pain, Onset and duration of sensory and motor block, Time to the first request for analgesic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141121020020N3
Registration date:2019-08-18, 1398/05/27
Registration timing:retrospective
Last update:2019-08-18, 1398/05/27
Update count:0
Registration date
2019-08-18, 1398/05/27
Registrant information
Name
Shahram Seyfi
Name of organization / entity
Babol University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8284
Email address
sh.seyfi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
2013-07-23, 1392/05/01
Actual recruitment end date
2014-01-21, 1392/11/01
Trial completion date
2014-01-21, 1392/11/01
Scientific title
The analgesic effect of paracetamol when added to lidocaine for intravenous regional anesthesia
Public title
The analgesic effect of paracetamol when added to lidocaine for intravenous regional anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20--60 years old
Patients undergoing hand surgeries
ASA ClassI,II
Exclusion criteria:
History of allergic reaction
Addiction
Pregnancy
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into three groups A, B and C 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,The participants allocation sequence in three groups performed with a
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
2013-07-16, 1392/04/25
Ethics committee reference number
MUBABOL.REC.1392.21
Health conditions studied
1
Description of health condition studied
Intera venous Regional Anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
Surgical site pain
Timepoint
After the start of surgical process (at 5, 10, 15, 20, 30, 40 and 50 min) and after the end of surgery
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Onset and duration of sensory and motor block
Timepoint
From the start of anesthetics injection to the end of operation
Method of measurement
Evaluate the patients response to needle hitting on surgical site and request of the patients to hand flexion and extension
3
Description
Time to the first request for analgesic
Timepoint
Once at the moment of first request
Method of measurement
Time elapsed from tourniquet deflation in minutes
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All patients would received 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. Also, patients received with peripheral venous catheter 20 ml normal saline.
Category
Treatment - Drugs
2
Description
Intervention group: All patients would received the same premedication (200 ml of normal saline, 1 mg of midazolam and 50 micrograms fentanyl).intravenous regional anesthesia with 300 mg parasetamol (40 ml) would be done.Also, patients received with peripheral venous catheter 20 ml normal saline.
Category
Treatment - Drugs
3
Description
Intervention group: All patients would received 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. Also, patients received with peripheral venous catheter 300 mg of paracetamol (20 ml).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
shahram Seyfi
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
ficu_ss@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Reza Ghadimi
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?