Comparison of Analgesic Effect of Ketorolac in Intravenous Injection and when Added to Lidocaine in Bier Block in Surgery for Traumatic Upper Extremity Injuries
Objective: To compare the analgesic effect of intravenous ketorolac added to lidocaine in Bier block in the patients undergoing surgery for traumatic upper extremity injuries.
Research Design: Conduction of a randomized, clinical trial
Inclusion criteria: patients aged 20 to 60 years; patients undergoing orthopedic surgery for traumatic injuries of upper extremity; eligible for Bier block; ASA I-II; duration of the surgery will be less than 90 minutes; Patients patient's mental ability to collaborate and answered the questions.
Exclusion criteria: Long-term use of analgesics (including opioid and non-narcotic); depression; Uncontrolled seizures; peripheral nerves diseases ;sensitivity to the study drugs; renal failure; lack of glucose-6-phosphate dehydrogenase; cardiovascular problems and infection in the injured limb; signs of nerve damage in the injured extremities; liver failure.
Interventions: In this study 96 patients with traumatic injury to the upper extremity ketorolac both intravenous systemic and topical added to lidocaine in the Bier block. Patients randomly divided into 3 groups of 32: Distilled water (DW) group: 3 mg / kg lidocaine 5.0 percent in 5 ml of distilled water solution for Bier blocks intravenous (systemic). Topical ketorolac group (RK): 3 mg / kg lidocaine 5.0 percent + 30 mg ketorolac as Bier block and 5 ml of distilled water for intravenous (systemic). Ketorolac group venous (IVK): 3 mg / kg lidocaine 5.0 per cent as Bier block solution and 5 ml distilled water contains 30 mg of ketorolac for intravenous (systemic). Pain intensity will be compared with NRS perioperative, the amount of pain medication needed during the first 24 hours after the operation, the first request for analgesics after the operation and administration of ketorolac and opioid-induced side effects will be investigated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015031419470N20
Registration date:2016-04-26, 1395/02/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-26, 1395/02/07
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Analgesic Effect of Ketorolac in Intravenous Injection and when Added to Lidocaine in Bier Block in Surgery for Traumatic Upper Extremity Injuries
Public title
Comparison of Analgesic Effect of Ketorolac in Intravenous Injection and when Added to Lidocaine in Blocks in the Orthopedic Surgeries.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 20 to 60 years; patients undergoing orthopedic surgery for traumatic injuries of upper extremity; eligible for Bier block; ASA I-II; duration of the surgery will be less than 90 minutes; Patients patient's mental ability to collaborate and answered the questions.
Exclusion criteria: Long-term use of analgesics (including opioid and non-narcotic); depression; Uncontrolled seizures; peripheral nerves diseases ;sensitivity to the study drugs; renal failure; lack of glucose-6-phosphate dehydrogenase; cardiovascular problems and infection in the injured limb; signs of nerve damage in the injured extremities; liver failure.
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:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University Of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.SUMS.Med.RED.1394.19
Health conditions studied
1
Description of health condition studied
Orthopaedic Surgery
ICD-10 code
M96.6
ICD-10 code description
Fracture of bone following insertion of orthopaedic implant, joint prosthesis, or bone plate
Primary outcomes
1
Description
Analgesia prioperatively and post operatively
Timepoint
Every 10 min in the operating room and every 15 min in the recovery ,every one hour at the six first hour in the ward , every two hour after six to 12 hours and every 4 hour until 24 hour
Method of measurement
NRS
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
24 hours after surgery
Method of measurement
Questionaire
Intervention groups
1
Description
Distilled water (DW) group: 3 mg / kg lidocaine 5.0 per cent in 5 ml of distilled water solution for Bier block intravenous (systemic).
Category
Treatment - Drugs
2
Description
Topical ketorolac group (RK): 3 mg / kg lidocaine 5.0 percent + 30 mg ketorolac as Bier block and 5 ml of distilled water for intravenous (systemic).
Category
Treatment - Drugs
3
Description
Ketorolac group venous (IVK): 3 mg / kg lidocaine 5.0 per cent as Bier block solution and 5 ml distilled water contains 30 mg of ketorolac for intravenous (systemic).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Maryam Ghadimi
Street address
Chamran Blv, Chamran Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice Chancellor for Research ,Shiraz University of Medical Sciences-7th floor-Central Building of Shiraz University of Medical Sciences , Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Ghadimi
Position
Physician, Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
ghadimi.maryam@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Afshin Amini
Position
Anesthesilogist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
afshinaminie@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz anesthesiology and critical care research center
Full name of responsible person
Farzaneh Masihi
Position
English Consultant
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Research Tower, 5 th floor, Khalili street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)