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

January 13, 2021 updated by: Bahattin Tuncali, Baskent University Ankara Hospital

Does Anesthetic Technique Affect Pneumatic Tourniquet Pressures in Upper Limb Fracture Surgery? A Comparison of General Anesthesia and Axillary Brachial Plexus Block

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Başkent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1 (General anesthesia group)

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

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.
ACTIVE_COMPARATOR: Group 2 (Multiple injection axillary block group)
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.
Procedure: Upper limb fracture surgery and arterial occlusion pressure (AOP) estimation based tourniquet pressure (TP) setting

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial and maximal systolic blood pressure (mmHg)
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.
Intraoperative
Arterial occlusion pressure (mmHg)
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.
Intraoperative
Initial and maximal tourniquet pressures (mmHg)
Time Frame: Intraoperative
Initial and maximal tourniquet pressures define first adjusted and maximal tourniquet pressures during surgery.
Intraoperative
Tourniquet time (minute)
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.
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The quality of bloodless surgical area
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.
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University Ankara Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 8, 2019

Primary Completion (ACTUAL)

January 9, 2021

Study Completion (ACTUAL)

January 9, 2021

Study Registration Dates

First Submitted

January 10, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (ACTUAL)

January 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA19/326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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