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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Side | Experimental | Surgical side requiring the use of a pneumatic tourniquet. |
|
| Non Surgical Side | No Intervention | Contralateral side (Control Thigh). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumatic tourniquet use | Device | Surgery requiring a pneumatic tourniquet on the thigh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative muscle dysfunction | Fall greater or equal than 10% of the voluntary isometric muscle contraction from basal | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Basal upper and lower extremity blood pressures | Pre spinal anesthesia measured blood pressures | Up to 2 hours pre spinal anesthesia |
| Upper and lower extremity blood pressures after spinal anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Bravo, MD | Contact | 56984276252 | dbravoadvis@uchile.cl | |
| Julian Aliste, MD | Contact | 56998189445 | julian.aliste@uchile.cl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universidad de Chile | Recruiting | Santiago | Santiago Metropolitan | 8380456 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24800642 | Result | 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. | |
| 21502865 | Result | 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. |
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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Surgical side can not be randomized. Only data assessor will be blinded.
Post spinal anesthesia measured blood pressures
| 10 minutes after spinal anesthesia |
| Arterial occlusion pressure | Doppler estimation of arterial occlusion pressure of the lower extremity surgical side | 10 minutes after spinal anesthesia |
| Pneumatic tourniquet inflation pressure | Arterial occlusion pressure plus a safety margin | 3 hours from tourniquet inflation |
| Pneumatic tourniquet inflation time | Time from inflation to release of the pneumatic tourniquet | 3 hours from tourniquet inflation |
| Quadriceps electromyographic activation profile | Basal and 24 hours (post surgery) quadriceps activation on surgical side | 24 hours |
| Quadriceps muscle tone | Basal and 24 hours (post surgery) measurement of quadriceps muscle tone on surgical side | 24 hours |
| Thigh perimeter | Basal and 24 hours (post surgery) bilateral measurement of thigh perimeter | 24 hours |
| Thigh pain | Basal and 24 hours (post surgery) bilateral thigh pain measured with a numerical rating scale (0-10) | 24 hours |
| Postoperative measurements time | Time from pneumatic tourniquet release to postoperative muscle function measurements | 24 hours |
| 16492857 | Result | 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. |
| 21161177 | Result | 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. |
| 11412159 | Result | 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. |
| 26969952 | Result | 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. |
| 26590567 | Result | 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. |
| 26100254 | Result | 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. |
| 25979462 | Result | 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. |
| 20152747 | Result | 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. |
| 11447547 | Result | 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. |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |