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Does Anesthetic Technique Affect Pneumatic Tourniquet Pressures in Upper Limb Fracture Surgery?

Primary Purpose

Initial Systolic Blood Pressure (mmHg), Arterial Occlusion Pressure (mmHg), Tourniquet Time (Minutes)

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Upper limb fracture surgery and arterial occlusion pressure (AOP) estimation based tourniquet pressure (TP) setting

About this trial

This is an interventional prevention trial for Initial Systolic Blood Pressure (mmHg) focused on measuring Pneumatic tourniquet, Pressure, Upper extremity, General anesthesia, Axillary brachial plexus block.

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Baskent University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group 1 (General anesthesia group)

Group 2 (Multiple injection axillary block group)

Arm Description

Upper limb fracture surgery will be performed with the aid of pneumatic tourniquet. General anesthesia will be induced with intravenous (IV) thiopental sodium and fentanyl. Rocuronium will be used as the neuromuscular blocking agent. Endotracheal tube will be placed and anesthesia will be maintained with sevoflurane and IV fentanyl while the lungs were ventilated with O2-N2O (50-50%) to achieve an EtCO2 at 30-35 mm Hg.

Multiple injection axillary block will be performed with the aid of a nerve stimulator. When the slight twitching of the motor response from the relevant muscles is achieved (at 0.4 mA, 2Hz, 0.1 ms) % 18-20 ml of Bupivacaine 0.5 (90-100 mg) will be injected.

Outcomes

Primary Outcome Measures

Initial and maximal systolic blood pressure (mmHg)

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.

Arterial occlusion pressure (mmHg)

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.

Initial and maximal tourniquet pressures (mmHg)

Initial and maximal tourniquet pressures define first adjusted and maximal tourniquet pressures during surgery.

Tourniquet time (minute)

Tourniquet time defines the time period between the inflation and deflation of the tourniquet cuff at the beginning and end of the surgery respectively.

Secondary Outcome Measures

The quality of bloodless surgical area

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.

Full Information

NCT ID

NCT04710225

First Posted

January 10, 2021

Last Updated

January 13, 2021

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