Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000892415
Ethics application status
Approved
Date submitted
9/06/2016
Date registered
6/07/2016
Date last updated
6/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of different volumes of local anesthetic used for fascia iliaca compartment block
Scientific title
Comparison of different volumes of local anesthetic used for fascia iliaca compartment block in patients undergoing elective knee or femur surgery
Secondary ID [1] 289507 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain 291536 0
Femur disorder requiring surgery 299345 0
Knee disorder requiring surgery 299346 0
Condition category
Condition code
Anaesthesiology 291914 291914 0 0
Pain management
Musculoskeletal 299329 299329 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three different doses of % 0.25 bupivacaine (0.3 ml/kg (Group 1), 0.4 ml/kg (Group 2), 0.5 ml/kg (Group 3) will be administered via nerve-block needle during single-shot fascia iliaca compartment block application after finishing lower extremity surgery under general anesthsia by an anesthesiologist
Intervention code [1] 289100 0
Treatment: Drugs
Comparator / control treatment
Three different doses of % 0.25 bupivacaine
0.3 ml/kg (Group 1),
0.4 ml/kg (Group 2),
0.5 ml/kg (Group 3)
Control group
Dose comparison

Outcomes
Primary outcome [1] 291824 0
postoperative pain will be assessed by 100mm(10 cm) visual analogue scale,
Timepoint [1] 291824 0
in first 24 hours after completion of block. (0, 1, 2, 4, 6, 12, 24th hour after fascia iliaca compartment block).
Secondary outcome [1] 325034 0
to evaluate additional analgesic need. cumulative diclofenac sodium doses will be recorded
Timepoint [1] 325034 0
in first 24 hours after completion of block. (0, 1, 2, 4, 6, 12, 24th hour after fascia iliaca compartment block).

Eligibility
Key inclusion criteria
Studies elective knee or femur surgery operations to be done with ASA I-II-III patients between the ages of 18 -80 will be included
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA IV-V
studies did not approve those,
abnormal coagulation profile Those with neurologic deficits to be implemented drug history of allergy sufferers,
pregnant women, dermatological disorders, and those with psychiatric patients suffering from the study will be kept

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2013
Date of last participant enrolment
Anticipated
Actual
15/05/2014
Date of last data collection
Anticipated
Actual
15/05/2014
Sample size
Target
45
Accrual to date
Final
45
Recruitment outside Australia
Country [1] 5950 0
Turkey
State/province [1] 5950 0
turkey

Funding & Sponsors
Funding source category [1] 289013 0
Hospital
Name [1] 289013 0
University of Gaziantep
Country [1] 289013 0
Turkey
Primary sponsor type
Individual
Name
metin KILINC
Address
.Faculty of Medicine, University of Gaziantep, university st. 27310 Sehitkamil Gaziantep
Country
Turkey
Secondary sponsor category [1] 287690 0
None
Name [1] 287690 0
Address [1] 287690 0
Country [1] 287690 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290820 0
Ethical Committee of Gaziantep University Hospitals
Ethics committee address [1] 290820 0
Gaziantep University, University st. 27310, Sehitkamil, GAziantep
Ethics committee country [1] 290820 0
Turkey
Date submitted for ethics approval [1] 290820 0
18/10/2013
Approval date [1] 290820 0
19/11/2013
Ethics approval number [1] 290820 0

Summary
Brief summary
In our study, we apply daily routine performed with different local anesthetic volume
FICB in observing the effectiveness of postoperative analgesia in patients with the most effective in patients aimed to find suitable local anesthetic volumes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47154 0
Dr metin kilinc
Address 47154 0
Faculty of Medicine, University of Gaziantep, university st. 27310 Sehitkamil Gaziantep Turkey
Country 47154 0
Turkey
Phone 47154 0
+90,532,4563703
Fax 47154 0
Email 47154 0
[email protected]
Contact person for public queries
Name 47155 0
Dr metin kilinc
Address 47155 0
Faculty of Medicine, University of Gaziantep, university st. 27310 Sehitkamil Gaziantep Turkey
Country 47155 0
Turkey
Phone 47155 0
+90,532,4563703
Fax 47155 0
Email 47155 0
[email protected]
Contact person for scientific queries
Name 47156 0
Dr metin kilinc
Address 47156 0
Faculty of Medicine, University of Gaziantep, university st. 27310 Sehitkamil Gaziantep Turkey
Country 47156 0
Turkey
Phone 47156 0
+90,532,4563703
Fax 47156 0
Email 47156 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.