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Effect of Tourniquet Use on Muscle Thigh Function.

Primary Purpose

Pneumatic Tourniquet, Muscle Weakness

Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Pneumatic tourniquet use
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pneumatic Tourniquet focused on measuring Pneumatic Tourniquet, Postoperative Muscle Dysfunction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Clínico Universidad de ChileRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgical Side

Non Surgical Side

Arm Description

Surgical side requiring the use of a pneumatic tourniquet.

Contralateral side (Control Thigh).

Outcomes

Primary Outcome Measures

Postoperative muscle dysfunction
Fall greater or equal than 10% of the voluntary isometric muscle contraction from basal

Secondary Outcome Measures

Basal upper and lower extremity blood pressures
Pre spinal anesthesia measured blood pressures
Upper and lower extremity blood pressures after spinal anesthesia
Post spinal anesthesia measured blood pressures
Arterial occlusion pressure
Doppler estimation of arterial occlusion pressure of the lower extremity surgical side
Pneumatic tourniquet inflation pressure
Arterial occlusion pressure plus a safety margin
Pneumatic tourniquet inflation time
Time from inflation to release of the pneumatic tourniquet
Quadriceps electromyographic activation profile
Basal and 24 hours (post surgery) quadriceps activation on surgical side
Quadriceps muscle tone
Basal and 24 hours (post surgery) measurement of quadriceps muscle tone on surgical side
Thigh perimeter
Basal and 24 hours (post surgery) bilateral measurement of thigh perimeter
Thigh pain
Basal and 24 hours (post surgery) bilateral thigh pain measured with a numerical rating scale (0-10)
Postoperative measurements time
Time from pneumatic tourniquet release to postoperative muscle function measurements

Full Information

First Posted
March 11, 2018
Last Updated
July 18, 2019
Sponsor
University of Chile
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1. Study Identification

Unique Protocol Identification Number
NCT03473106
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumatic Tourniquet, Muscle Weakness
Keywords
Pneumatic Tourniquet, Postoperative Muscle Dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Surgical side can not be randomized. Only data assessor will be blinded.
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical Side
Arm Type
Experimental
Arm Description
Surgical side requiring the use of a pneumatic tourniquet.
Arm Title
Non Surgical Side
Arm Type
No Intervention
Arm Description
Contralateral side (Control Thigh).
Intervention Type
Device
Intervention Name(s)
Pneumatic tourniquet use
Intervention Description
Surgery requiring a pneumatic tourniquet on the thigh
Primary Outcome Measure Information:
Title
Postoperative muscle dysfunction
Description
Fall greater or equal than 10% of the voluntary isometric muscle contraction from basal
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Basal upper and lower extremity blood pressures
Description
Pre spinal anesthesia measured blood pressures
Time Frame
Up to 2 hours pre spinal anesthesia
Title
Upper and lower extremity blood pressures after spinal anesthesia
Description
Post spinal anesthesia measured blood pressures
Time Frame
10 minutes after spinal anesthesia
Title
Arterial occlusion pressure
Description
Doppler estimation of arterial occlusion pressure of the lower extremity surgical side
Time Frame
10 minutes after spinal anesthesia
Title
Pneumatic tourniquet inflation pressure
Description
Arterial occlusion pressure plus a safety margin
Time Frame
3 hours from tourniquet inflation
Title
Pneumatic tourniquet inflation time
Description
Time from inflation to release of the pneumatic tourniquet
Time Frame
3 hours from tourniquet inflation
Title
Quadriceps electromyographic activation profile
Description
Basal and 24 hours (post surgery) quadriceps activation on surgical side
Time Frame
24 hours
Title
Quadriceps muscle tone
Description
Basal and 24 hours (post surgery) measurement of quadriceps muscle tone on surgical side
Time Frame
24 hours
Title
Thigh perimeter
Description
Basal and 24 hours (post surgery) bilateral measurement of thigh perimeter
Time Frame
24 hours
Title
Thigh pain
Description
Basal and 24 hours (post surgery) bilateral thigh pain measured with a numerical rating scale (0-10)
Time Frame
24 hours
Title
Postoperative measurements time
Description
Time from pneumatic tourniquet release to postoperative muscle function measurements
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Bravo, MD
Phone
56984276252
Email
dbravoadvis@uchile.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Julian Aliste, MD
Phone
56998189445
Email
julian.aliste@uchile.cl
Facility Information:
Facility Name
Hospital Clínico Universidad de Chile
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8380456
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Bravo, MD
Phone
56984276252
Email
dbravoadvis@uchile.cl
First Name & Middle Initial & Last Name & Degree
Julian Aliste, MD
Phone
56998189445
Email
julian.aliste@uchile.cl

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24800642
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.
Results Reference
result
PubMed Identifier
21502865
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.
Results Reference
result
PubMed Identifier
16492857
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.
Results Reference
result
PubMed Identifier
21161177
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.
Results Reference
result
PubMed Identifier
11412159
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. Erratum In: Anaesthesia 2001 Aug;56(8):821. Kavanaugh R [corrected to Kavanagh R].
Results Reference
result
PubMed Identifier
26969952
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.
Results Reference
result
PubMed Identifier
26590567
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.
Results Reference
result
PubMed Identifier
26100254
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.
Results Reference
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PubMed Identifier
25979462
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.
Results Reference
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PubMed Identifier
20152747
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.
Results Reference
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PubMed Identifier
11447547
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.
Results Reference
result

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Effect of Tourniquet Use on Muscle Thigh Function.

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