Clinical trial NCT04710225: Does Anesthetic Technique Affect Pneumatic Tourniquet Pressures in Upper Limb Fracture Surgery?
Official title: Does Anesthetic Technique Affect Pneumatic Tourniquet Pressures in Upper Limb Fracture Surgery? A Comparison of General Anesthesia and Axillary Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Initial Systolic Blood Pressure (mmHg)
Arterial Occlusion Pressure (mmHg)
Tourniquet Time (Minutes)
Quality of Bloodless Surgical Field (4 Point Scale)
Initial Tourniquet Pressure (mmHg)
Maximal Systolic Blood Pressure (mmHg)
Maximal Tourniquet Pressure (mmHg)
Keywords: Pneumatic tourniquet
Pressure
Upper extremity
General anesthesia
Axillary brachial plexus block.
Lead sponsor: Baskent University Ankara Hospital
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing upper limb fracture surgery

Exclusion Criteria:

* The age below 18 and above 85 years,
* American Society of Anesthesiology (ASA) physical status \>2
* Any contraindication to axillary block or general anesthesia
* Any contraindication to tourniquet use
* Adverse reaction history to anesthetic drugs
* Severe anemia
* Refusal to give informed consent

Primary outcomes:
measure: Initial and maximal systolic blood pressure (mmHg)
timeFrame: Intraoperative
measure: Arterial occlusion pressure (mmHg)
timeFrame: Intraoperative
measure: Initial and maximal tourniquet pressures (mmHg)
timeFrame: Intraoperative
measure: Tourniquet time (minute)
timeFrame: Intraoperative
Secondary outcomes:
measure: The quality of bloodless surgical area
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
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