Clinical trial NCT03473106: Effect of Tourniquet Use on Muscle Thigh Function.
Official title: Effect of the Use of Tourniquet in the Thigh: a Biomechanical Analysis on the Muscular Function of the Quadriceps in the Postoperative Period.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumatic Tourniquet
Muscle Weakness
Keywords: Pneumatic Tourniquet
Postoperative Muscle Dysfunction
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative muscle dysfunction
timeFrame: 24 hours
Secondary outcomes:
measure: Basal upper and lower extremity blood pressures
timeFrame: Up to 2 hours pre spinal anesthesia
measure: Upper and lower extremity blood pressures after spinal anesthesia
timeFrame: 10 minutes after spinal anesthesia
measure: Arterial occlusion pressure
timeFrame: 10 minutes after spinal anesthesia
measure: Pneumatic tourniquet inflation pressure
timeFrame: 3 hours from tourniquet inflation
measure: Pneumatic tourniquet inflation time
timeFrame: 3 hours from tourniquet inflation
measure: Quadriceps electromyographic activation profile
timeFrame: 24 hours
measure: Quadriceps muscle tone
timeFrame: 24 hours
measure: Thigh perimeter
timeFrame: 24 hours
measure: Thigh pain
timeFrame: 24 hours
measure: Postoperative measurements time
timeFrame: 24 hours
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
state: Metropolitana
Study officials:
References:
citation: Halladin NL, Zahle FV, Rosenberg J, Gogenur I. Interventions to reduce tourniquet-related ischaemic damage in orthopaedic surgery: a qualitative systematic review of randomised trials. Anaesthesia. 2014 Sep;69(9):1033-50. doi: 10.1111/anae.12664. Epub 2014 May 7.
citation: Estebe JP, Davies JM, Richebe P. The pneumatic tourniquet: mechanical, ischaemia-reperfusion and systemic effects. Eur J Anaesthesiol. 2011 Jun;28(6):404-11. doi: 10.1097/EJA.0b013e328346d5a9.
citation: Horlocker TT, Hebl JR, Gali B, Jankowski CJ, Burkle CM, Berry DJ, Zepeda FA, Stevens SR, Schroeder DR. Anesthetic, patient, and surgical risk factors for neurologic complications after prolonged total tourniquet time during total knee arthroplasty. Anesth Analg. 2006 Mar;102(3):950-5. doi: 10.1213/01.ane.0000194875.05587.7e.
citation: Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15.
citation: Kam PC, Kavanagh R, Yoong FF. The arterial tourniquet: pathophysiological consequences and anaesthetic implications. Anaesthesia. 2001 Jun;56(6):534-45. doi: 10.1046/j.1365-2044.2001.01982.x.
citation: Tuncali B, Boya H, Kayhan Z, Arac S, Camurdan MA. Clinical utilization of arterial occlusion pressure estimation method in lower limb surgery: effectiveness of tourniquet pressures. Acta Orthop Traumatol Turc. 2016;50(2):171-7. doi: 10.3944/AOTT.2015.15.0175.
citation: Guler O, Mahirogullari M, Isyar M, Piskin A, Yalcin S, Mutlu S, Sahin B. Comparison of quadriceps muscle volume after unilateral total knee arthroplasty with and without tourniquet use. Knee Surg Sports Traumatol Arthrosc. 2016 Aug;24(8):2595-605. doi: 10.1007/s00167-015-3872-5. Epub 2015 Nov 21.
citation: Dennis DA, Kittelson AJ, Yang CC, Miner TM, Kim RH, Stevens-Lapsley JE. Does Tourniquet Use in TKA Affect Recovery of Lower Extremity Strength and Function? A Randomized Trial. Clin Orthop Relat Res. 2016 Jan;474(1):69-77. doi: 10.1007/s11999-015-4393-8.
citation: Kruse H, Christensen KP, Moller AM, Gogenur I. Tourniquet use during ankle surgery leads to increased postoperative opioid use. J Clin Anesth. 2015 Aug;27(5):380-4. doi: 10.1016/j.jclinane.2015.03.034. Epub 2015 May 12.
citation: Smith TO, Hing CB. The efficacy of the tourniquet in foot and ankle surgery? A systematic review and meta-analysis. Foot Ankle Surg. 2010 Mar;16(1):3-8. doi: 10.1016/j.fas.2009.03.006. Epub 2009 May 27.
citation: Nicholas SJ, Tyler TF, McHugh MP, Gleim GW. The effect on leg strength of tourniquet use during anterior cruciate ligament reconstruction: A prospective randomized study. Arthroscopy. 2001 Jul;17(6):603-7. doi: 10.1053/jars.2001.24854.