Effect of Tourniquet Use on Muscle Thigh Function.

Muscle Weakness Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03473106
• Other study ID #: OAIC 919/17
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: April 2020

Study information

• Verified date: July 2019
• Source: University of Chile
• Contact: Daniela Bravo, MD
• Phone: 56984276252
• Email: dbravoadvis[@]uchile.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Pneumatic Tourniquet

Intervention

Device:
• Pneumatic tourniquet use
Surgery requiring a pneumatic tourniquet on the thigh

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad de Chile	Santiago	Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (11)

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. — View 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. Review. — View 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 — View Citation

Halladin NL, Zahle FV, Rosenberg J, Gögenur 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 201 — View 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 — View Citation

Kam PC, Kavanagh R, Yoong FF. The arterial tourniquet: pathophysiological consequences and anaesthetic implications. Anaesthesia. 2001 Jun;56(6):534-45. Review. Erratum in: Anaesthesia 2001 Aug;56(8):821. Kavanaugh R [corrected to Kavanagh R]. — View Citation

Kruse H, Christensen KP, Møller AM, Gögenur 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Tuncali B, Boya H, Kayhan Z, Araç S, Çamurdan 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.2015.15.0 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative muscle dysfunction	Fall greater or equal than 10% of the voluntary isometric muscle contraction from basal	24 hours
Secondary	Basal upper and lower extremity blood pressures	Pre spinal anesthesia measured blood pressures	Up to 2 hours pre spinal anesthesia
Secondary	Upper and lower extremity blood pressures after spinal anesthesia	Post spinal anesthesia measured blood pressures	10 minutes after spinal anesthesia
Secondary	Arterial occlusion pressure	Doppler estimation of arterial occlusion pressure of the lower extremity surgical side	10 minutes after spinal anesthesia
Secondary	Pneumatic tourniquet inflation pressure	Arterial occlusion pressure plus a safety margin	3 hours from tourniquet inflation
Secondary	Pneumatic tourniquet inflation time	Time from inflation to release of the pneumatic tourniquet	3 hours from tourniquet inflation
Secondary	Quadriceps electromyographic activation profile	Basal and 24 hours (post surgery) quadriceps activation on surgical side	24 hours
Secondary	Quadriceps muscle tone	Basal and 24 hours (post surgery) measurement of quadriceps muscle tone on surgical side	24 hours
Secondary	Thigh perimeter	Basal and 24 hours (post surgery) bilateral measurement of thigh perimeter	24 hours
Secondary	Thigh pain	Basal and 24 hours (post surgery) bilateral thigh pain measured with a numerical rating scale (0-10)	24 hours
Secondary	Postoperative measurements time	Time from pneumatic tourniquet release to postoperative muscle function measurements	24 hours