Comparing the effectiveness of adding paracetamol and dexamethasone to lidocaine for intravenous block of upper extremity on severity of pain and period of painless during and after surgery.
1) Obgectives: Comparing the effectiveness of paracetamol and dexamethasone on the onset and duration of sensory and motor block, tourniquet pain and postoperative analgesia when these drugs are added to lidocaine
2) Design: Sixty patients undergoing upper limb surgery, as double-blind were randomized into four groups.
3) Setting and conduct: After the arrival of patient to the operating room, an intravenous line is established at dorsal vein of the operative hand. Then the proximal cuff of a pneumatic tourniquet that is placed around the upper arm, is inflated to 250 mmHg and IV regional anesthesia (IVRA) is done. Then the desired outcome variables are evaluated.
4) Participants including major eligibility criteria: patients 20 to 60 years old; candidate for upper extremity surgery and with ASA I or II are enrolled and patients with lidocaine allergy; infection; open fracture of limb; liver disease and addiction to opium and alcohol are excluded.
5) Intervention: All of the patients are received lidocaine (3 mg/kg) diluted with normal saline to a total volume of 40 mL. Group 1 received only lidocaine, group 2: lidocaine and dexamethason (8 mg), group 3: lidocaine and paracetamol (300 mg) and group 4: lidocaine and dexamethason (8 mg) and paracetamol (300 mg).
6) Main outcome measures: These include the following: the onset and duration of sensory and motor block, tourniquet pain and surgical site pain
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209053104N2
Registration date:2012-12-20, 1391/09/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-20, 1391/09/30
Registrant information
Name
Mohammad Shabani
Name of organization / entity
Kerman Neuroscience Research Center
Country
Iran (Islamic Republic of)
Phone
+98 34 1226 4196
Email address
shabani@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-12-05, 1391/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of adding paracetamol and dexamethasone to lidocaine for intravenous block of upper extremity on severity of pain and period of painless during and after surgery.
Public title
Comparing the effectiveness of adding paracetamol and dexamethasone to lidocaine for intravenous block of upper extremity on severity of pain and period of painless during and after surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20 to 60 years old; candidate for upper extremity surgery and ASA I or II.
Exclusion criteria:
Lidocaine allergy; infection; open fracture of limb; liver disease and addiction to opium and alcohol
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Vice chancellor for research, Kerman University of Medical Sciences
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman
City
Kerman
Postal code
Approval date
2012-02-20, 1390/12/01
Ethics committee reference number
k/90/462
Health conditions studied
1
Description of health condition studied
IV 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
Tourniquet site pain
Timepoint
After applying the tourniquet and during surgery (at 5, 10, 15, 20, 30, 40 and 50 min)
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Mean Arterial Pressure (MAP)
Timepoint
Before and after applying the tourniquet, during surgery (at 5, 10, 15, 20, 30, 40 and 50 min) and after opening the tourniquet
Method of measurement
By monitoring devices in the operating room (produced by Saadat Co)
2
Description
Heart Rate
Timepoint
Before and after applying the tourniquet, during surgery (at 5, 10, 15, 20, 30, 40 and 50 min) and after opening the tourniquet
Method of measurement
By monitoring devices in the operating room (produced by Saadat Co)
3
Description
Blood Oxygen Saturation
Timepoint
Before and after applying the tourniquet, during surgery (at 5, 10, 15, 20, 30, 40 and 50 min) and after opening the tourniquet
Method of measurement
By the pulse oximeter attached to the monitoring devices in the operating room (produced by Saadat Co)
Intervention groups
1
Description
Group 1: Patients are received lidocaine (3 mg/kg), that diluted with normal saline to a total volume of 40 mL (Injection time: 90 seconds), for regional anesthesia.
Category
Treatment - Drugs
2
Description
Group 2: Patients are received lidocaine (3 mg/kg) and dexamethason (8 mg), that diluted with normal saline to a total volume of 40 mL (Injection time: 90 seconds), for regional anesthesia.
Category
Treatment - Drugs
3
Description
Group 3:Patients are received lidocaine (3 mg/kg) and paracetamol (300 mg), that diluted with normal saline to a total volume of 40 mL (Injection time: 90 seconds), for regional anesthesia.
Category
Treatment - Drugs
4
Description
Group 4: patients are received lidocaine (3 mg/kg) and dexamethason (8 mg) and paracetamol (300 mg), that diluted with normal saline to a total volume of 40 mL (Injection time: 90 seconds), for regional anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic operation room in Kerman Shahid Bahonar Hospital