Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000057684
Ethics application status
Approved
Date submitted
6/01/2014
Date registered
20/01/2014
Date last updated
20/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Ultrasound Guided Saphenous Nerve Block using Two Different Anatomical Approaches in patients undergoing knee surgery
Scientific title
Comparison of the analgesic efficacy and onset time of the ultrasound-guided saphenous nerve block using two different anatomical approach that one of them is subsartorial and the other is level of medial condylar, addition to sciatic nerve block in all patients undergoing knee surgery.
Secondary ID [1] 283850 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lower extremity surgery
 290824 0
ultrasound guided nerve block 290825 0
anesthesia and analgesia 290826 0
Condition category
Condition code
Anaesthesiology 291192 291192 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We apply Ultrasound guided saphenous nerve block at level of medial condyl with 5 mL % 0.25 levobupivacaine + % 1 lidocaine for intraoperative anaesthesia management undergoing sub-knee surgery
Intervention code [1] 288529 0
Treatment: Drugs
Comparator / control treatment
We apply Ultrasound guided saphenous nerve block called subsartorial tecnique at level of mid-thigh with 5 mL % 0.25 levobupivacaine + % 1 lidocaine for intraoperative anaesthesia management undergoing sub-knee surgery
Control group
Active

Outcomes
Primary outcome [1] 291179 0
Duration of anaesthetic effect which is assessed using pin prick test on innervation area of saphenous nerve.
Timepoint [1] 291179 0
First 24 hours since injection
Secondary outcome [1] 306193 0
onset time of sensorial block which is assessed using pin prick test on innervation area of saphenous nerve.
Timepoint [1] 306193 0
From injection to start surgery
Secondary outcome [2] 306194 0
patient satisfaction which is assessed using a numeric scale including 0-4 point. 0; not satisfied, 4; very satisfied
Timepoint [2] 306194 0
First 24 hours post injection

Eligibility
Key inclusion criteria
American Society of Anesthesiologist (ASA) class I-III patients who were scheduled for sub-knee surgery
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychiatric illness, Diabetes mellitus, any organ failure and known hypersensitivity to relevant drugs.

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
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5716 0
Turkey
State/province [1] 5716 0

Funding & Sponsors
Funding source category [1] 288500 0
Hospital
Name [1] 288500 0
Gaziantep University Hospital
Country [1] 288500 0
Turkey
Primary sponsor type
Individual
Name
Levent Sahin
Address
Gaziantep University, Universityst. 27310 Sehitkamil Gaziantep
Country
Turkey
Secondary sponsor category [1] 287205 0
None
Name [1] 287205 0
Address [1] 287205 0
Country [1] 287205 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290358 0
Ethical Committee of Gaziantep University
Ethics committee address [1] 290358 0
Gaziantep University, University st. 27310, Sehitkamil, GAziantep
Ethics committee country [1] 290358 0
Turkey
Date submitted for ethics approval [1] 290358 0
Approval date [1] 290358 0
Ethics approval number [1] 290358 0

Summary
Brief summary
The present study was designed to compare and evaluate to applicable the ultrasound guided saphenous nerve blocks which are supsartorial approach and medial condyl approach, and measure to onset time, block duration time, patient satisfaction. Sixty patients between 18 to 60 years of age undergoing sub-knee surgery were randomized to two groups. Intervention(s): Saphenous nerve block performs using the ultrasound-guided technique with 5 mL 0.25 % levobupivacaine+ %1 lidocaine with either subsartorial tecnique or medial condyl tecnique.
Main outcome measures: Blocks duration time, block onset time and patient satisfaction over the course of 24 hours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45314 0
A/Prof Levent Sahin
Address 45314 0
Gaziantep University, University st. 27310, SEhitkamil Gaziantep
Country 45314 0
Turkey
Phone 45314 0
+905052662564
Fax 45314 0
Email 45314 0
[email protected]
Contact person for public queries
Name 45315 0
A/Prof Levent Sahin
Address 45315 0
Gaziantep University, University st. 27310, SEhitkamil Gaziantep
Country 45315 0
Turkey
Phone 45315 0
+905052662564
Fax 45315 0
Email 45315 0
[email protected]
Contact person for scientific queries
Name 45316 0
A/Prof Levent Sahin
Address 45316 0
Gaziantep University, University st. 27310, SEhitkamil Gaziantep
Country 45316 0
Turkey
Phone 45316 0
+905052662564
Fax 45316 0
Email 45316 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.