Effect of Tourniquet Use on Muscle Thigh Function.
- Conditions
- Pneumatic TourniquetMuscle Weakness
- Interventions
- Device: Pneumatic tourniquet use
- Registration Number
- NCT03473106
- Lead Sponsor
- University of Chile
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Patients undergoing forefoot surgery that requires the use of a pneumatic tourniquet
- American Society of Anesthesiologists classification 1-3
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgical Side Pneumatic tourniquet use Surgical side requiring the use of a pneumatic tourniquet.
- Primary Outcome Measures
Name Time Method Postoperative muscle dysfunction 24 hours Fall greater or equal than 10% of the voluntary isometric muscle contraction from basal
- Secondary Outcome Measures
Name Time Method Thigh pain 24 hours Basal and 24 hours (post surgery) bilateral thigh pain measured with a numerical rating scale (0-10)
Postoperative measurements time 24 hours Time from pneumatic tourniquet release to postoperative muscle function measurements
Upper and lower extremity blood pressures after spinal anesthesia 10 minutes after spinal anesthesia Post spinal anesthesia measured blood pressures
Arterial occlusion pressure 10 minutes after spinal anesthesia Doppler estimation of arterial occlusion pressure of the lower extremity surgical side
Basal upper and lower extremity blood pressures Up to 2 hours pre spinal anesthesia Pre spinal anesthesia measured blood pressures
Pneumatic tourniquet inflation pressure 3 hours from tourniquet inflation Arterial occlusion pressure plus a safety margin
Pneumatic tourniquet inflation time 3 hours from tourniquet inflation Time from inflation to release of the pneumatic tourniquet
Quadriceps electromyographic activation profile 24 hours Basal and 24 hours (post surgery) quadriceps activation on surgical side
Quadriceps muscle tone 24 hours Basal and 24 hours (post surgery) measurement of quadriceps muscle tone on surgical side
Thigh perimeter 24 hours Basal and 24 hours (post surgery) bilateral measurement of thigh perimeter
Trial Locations
- Locations (1)
Hospital Clínico Universidad de Chile
🇨🇱Santiago, Metropolitana, Chile