Comparison the effect of 0.5% lidocaine local analgesia in combination with and without ketorolac in Bier's Block method in patients with forearm fracture
Objective: Clinical trial of comparison the effect of 0.5% lidocaine local analgesia combination with and without ketorolac in Bier's Block method in patients with forearm fracture. Design of the study: randomization using random permuted blocks, convenience sampling, double-blind, single-center, phase II trial. Study population: all patients of forearm fracture with ASA PS I and II. Main inclusion criteria: age limitation 20-50 years; plating candidates of forearm fracture with ASA PS I and II. Main exclusion criteria: positive history of sensitivity to NSAIDs; history of asthma, nasal polyp, bronchospasm or angioedema; history of bleeding of gastric ulcer; medium to severe renal failure; pregnant women; addiction; multiple fractures. Sample size: 90. Interventions: First group: intravenous infusion of 40 miligrams of 0.5% lidocaine in combination with 1 milligram ketorolac plus 1 cc 0.09% normal saline; second group: intravenous infusion of 40 milligrams of 0.5% lidocaine plus 2 milligrams ketorolac; third group: intravenous infusion of 40 milligrams of 0.5% lidocaine in combination with 2 cc 0.09% normal saline(placebo). Intervention time: before the operation. Outcomes: pain during closing of tourniquet; pain after tourniquet deflation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021232520N1
Registration date:2017-04-10, 1396/01/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-10, 1396/01/21
Registrant information
Name
Leila Kadkhudaei
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5799
Email address
l.kadkhodaee@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2016-06-23, 1395/04/03
Expected recruitment end date
2017-06-24, 1396/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of 0.5% lidocaine local analgesia in combination with and without ketorolac in Bier's Block method in patients with forearm fracture
Public title
Comparison the effect of lidocaine local analgesia in combination with and without ketorolac in patients with forearm fracture
Purpose
Supportive
Inclusion/Exclusion criteria
Main inclusion criteria: age limitation 20-50 years; plating candidates of forearm fracture with ASA PS I and II. Main exclusion criteria: positive history of sensitivity to NSAIDs; history of asthma, nasal polyp, bronchospasm or angioedema; history of bleeding of gastric ulcer; medium to severe renal failure; pregnant women; addiction; multiple fractures.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
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 Zahedan University of Medical Sciences
Street address
Ethics Committee of Zahedan University of Medical Sciences, Zahedan University of Medical Sciences, Dr.Hesabi Square, Zahedan
City
Zahedan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.ZAUMS.REC.1395.36
Health conditions studied
1
Description of health condition studied
Forearm fracture
ICD-10 code
S52.0, S52
ICD-10 code description
Fracture of forearm
Primary outcomes
1
Description
Pain after tourniquet deflation
Timepoint
half of houre,two houres, four houres, six houres, 12 houres and 24 houres after tourniquet deflation
Method of measurement
VAS Criteria
2
Description
Pain during tourniquet closure
Timepoint
5, 10, 15, 20 and 30 minutes after infusion
Method of measurement
VAS Criteria
Secondary outcomes
empty
Intervention groups
1
Description
First group of intervention: intravenous infusion of 40 miligrams of 0.5% lidocaine in combination with 1 milligram ketorolac plus 1 cc 0.09% normal saline
Category
Treatment - Drugs
2
Description
Second group of intervention: intravenous infusion of 40 milligrams of 0.5% lidocaine plus 2 milligrams ketorolac
Category
Treatment - Drugs
3
Description
Control group: intravenous infusion of 40 milligrams of 0.5% lidocaine in combination with 2 cc 0.09% normal saline(placebo)