Baskent University
Ankara, Turkey (Türkiye)
NCT Number: NCT04710225
In pneumatic tourniquet applications, the use of an individualized, lowest-effective tourniquet pressure (TP) has been recommended, in order to avoid pressure related complications. The aim of this study is to compare the effects of general anesthesia and axillary block on arterial occlusion pressure (AOP) estimation based TP settings in upper limb fracture surgery.
After, ethical committee approval 80 adult patients undergoing upper limb fracture surgery who gave their signed informed consent will be included. The age below 18 and above 85 years, American Society of Anesthesiology (ASA) physical status >2, any contraindication to axillary block or GA, adverse reaction history to anesthetic drugs, severe anemia, and refusal to give informed consent will be the exclusion criteria. The patients will be randomized to one of two study groups using a computer-generated randomization list to receive GA (Group 1) and axillary block (Group 2).
Main endpoints are initial and maximal blood pressures, AOP, initial and maximal TPs, and tourniquet time. Additionally, the surgeon will evaluate the quality of bloodless surgical area with respect to the amount of blood using a 4-point scale (1: Excellent= No blood in the surgical field, 2: Good= Some blood in the surgical field but no interference with surgery, 3: Fair= Blood in the surgical field but no significant interference with surgery, 4: Poor= Blood in the surgical field obscures the view) at the beginning, in the middle, and at the end of the surgical procedure. The patients will be observed for signs of tourniquet related complications by a blind investigator. SPSS 20.0 for Windows is used for data analysis. The t test and the χ2 test will be used for continuous and categorical data respectively. A P value below 0.05 will be considered as statistically significant.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Ankara, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Upper limb fracture surgery will be performed with the aid of a pneumatic tourniquet.
The cuff (11 cm) of the tourniquet will be placed around the arm with the distal edge 5 cm above the olecranon. AOP estimation formula according to initial systolic blood pressure (SBP) and Tissue Padding Coefficient (KTP) values (AOP= [SBP+10]/KTP) from a list (Table 1) will be used to calculate AOP (17). After calculation of AOP, a safety margin of 20 mmHg will be added to AOP to determine the TP (TP=AOP+20 mm Hg). Exsanguination of the limb will be provided with an Esmarch bandage and the cuff will be inflated to the predetermined TP. TP will be manually raised in response to each 10 mmHg increase in SBP during the surgical procedure.
Time frame: Intraoperative
Initial and maximal systolic blood pressures define the systolic blood pressures measured and recorded by the patient monitor just before tourniquet inflation and during tourniquet application respectively.
Time frame: Intraoperative
Arterial occlusion pressure is the minimal tourniquet pressure required to cease arterial blood flow to the limb and calculated with AOP estimation formula according to initial SBP and Tissue Padding Coefficient (KTP) values (AOP= [SBP+10]/KTP) from a list.
Time frame: Intraoperative
Initial and maximal tourniquet pressures define first adjusted and maximal tourniquet pressures during surgery.
Time frame: Intraoperative
Tourniquet time defines the time period between the inflation and deflation of the tourniquet cuff at the beginning and end of the surgery respectively.
Time frame: Intraoperative
The quality of bloodless surgical area will be evaluated by the surgeon respect to the amount of blood using a 4-point scale (1: Excellent= No blood in the surgical field, 2: Good= Some blood in the surgical field but no interference with surgery, 3: Fair= Blood in the surgical field but no significant interference with surgery, 4: Poor= Blood in the surgical field obscures the view) at the beginning, in the middle, and at the end of the surgical procedure.
Baskent University Ankara Hospital
Other
Does Anesthetic Technique Affect Pneumatic Tourniquet Pressures in Upper Limb Fracture Surgery? A Comparison of General Anesthesia and Axillary Brachial Plexus Block
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