Effect of Tourniquet Use on Muscle Thigh Function.

University of Chile

Status: Unknown

Conditions: Pneumatic Tourniquet; Muscle Weakness

Treatments: Device: Pneumatic tourniquet use

Study type: Interventional

Funder types: Other

Identifiers

NCT03473106

OAIC 919/17

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Surgical Side

Experimental group

Description:

Surgical side requiring the use of a pneumatic tourniquet.

Treatment:

Device: Pneumatic tourniquet use

Non Surgical Side

No Intervention group

Description:

Contralateral side (Control Thigh).