Effect of Tourniquet Use on Muscle Thigh Function.

July 18, 2019 updated by: Daniela Bravo Advis, University of Chile

Effect of the Use of Tourniquet in the Thigh: a Biomechanical Analysis on the Muscular Function of the Quadriceps in the Postoperative Period.

The use of a pneumatic tourniquet with the purpose of maintaining an operative field free of blood is a common practice in orthopedic surgery. Its use is associated with local and systemic consequences related to hemodynamic and reperfusion ischemia phenomena. Although is known that its use is not an innocuous measure, there is still certain degree blurriness regarding the potential metabolic and functional consequences that may result in the involved limb.

In this trial, the investigators are setting out to discriminate the effect of the pneumatic tourniquet on thigh muscle function (strength, tone and activation). The hypothesis is that the pneumatic tourniquet by itself causes a significant postoperative muscular dysfunction of the quadriceps and, thus, the main outcome will be the presence of postoperative quadriceps muscle dysfunction, defined as a fall greater than or equal to 10% of the maximal voluntary isometric contraction measured at 24 hours post surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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

  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile, 8380456

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing forefoot surgery that requires the use of a pneumatic tourniquet
  • American Society of Anesthesiologists classification 1-3

Exclusion Criteria:

  • Ambulatory surgery
  • Adults who are unable to give their own consent
  • Pre-existing neuropathy or myopathy
  • Contraindication of tourniquet use
  • Bilateral surgery
  • Pregnancy
  • Hip, thigh, knee, leg or ankle pathologies that prevent or contraindicate using a dynamometer, tonometer or surface electromyographer
  • Arterial hypertension with systolic pressures above 200mmHg
  • Renal failure
  • Hepatic failure

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical Side
Surgical side requiring the use of a pneumatic tourniquet.
Device: Pneumatic tourniquet use
Surgery requiring a pneumatic tourniquet on the thigh
No Intervention: Non Surgical Side
Contralateral side (Control Thigh).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative muscle dysfunction
Time Frame: 24 hours
Fall greater or equal than 10% of the voluntary isometric muscle contraction from basal
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Basal upper and lower extremity blood pressures
Time Frame: Up to 2 hours pre spinal anesthesia
Pre spinal anesthesia measured blood pressures
Up to 2 hours pre spinal anesthesia
Upper and lower extremity blood pressures after spinal anesthesia
Time Frame: 10 minutes after spinal anesthesia
Post spinal anesthesia measured blood pressures
10 minutes after spinal anesthesia
Arterial occlusion pressure
Time Frame: 10 minutes after spinal anesthesia
Doppler estimation of arterial occlusion pressure of the lower extremity surgical side
10 minutes after spinal anesthesia
Pneumatic tourniquet inflation pressure
Time Frame: 3 hours from tourniquet inflation
Arterial occlusion pressure plus a safety margin
3 hours from tourniquet inflation
Pneumatic tourniquet inflation time
Time Frame: 3 hours from tourniquet inflation
Time from inflation to release of the pneumatic tourniquet
3 hours from tourniquet inflation
Quadriceps electromyographic activation profile
Time Frame: 24 hours
Basal and 24 hours (post surgery) quadriceps activation on surgical side
24 hours
Quadriceps muscle tone
Time Frame: 24 hours
Basal and 24 hours (post surgery) measurement of quadriceps muscle tone on surgical side
24 hours
Thigh perimeter
Time Frame: 24 hours
Basal and 24 hours (post surgery) bilateral measurement of thigh perimeter
24 hours
Thigh pain
Time Frame: 24 hours
Basal and 24 hours (post surgery) bilateral thigh pain measured with a numerical rating scale (0-10)
24 hours
Postoperative measurements time
Time Frame: 24 hours
Time from pneumatic tourniquet release to postoperative muscle function measurements
24 hours

Collaborators and Investigators

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

Sponsor

University of Chile

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)

April 24, 2018

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

March 11, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 22, 2018

Study Record Updates

Last Update Posted (Actual)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OAIC 919/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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