Femoral Triangle Block: Early Mobilization and Postoperative Analgesia After Total Knee Arthroplasty
Primary Purpose
Arthroplasty, Replacement, Knee, Anesthesia, Conduction, Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Apex Femoral Triangle Block
Femoral Nerve Block
Adductor Canal Block
Sponsored by
About this trial
This is an interventional treatment trial for Arthroplasty, Replacement, Knee
Eligibility Criteria
Inclusion Criteria:
- Subjects of any gender, from 18 to 90 years old that accept to participate in the study.
- Programmed primary total knee arthroplasty surgery
Exclusion Criteria:
- Emergent surgery
- Reinterventions
- Unstable psychiatric pathology, dementia
- Kidney or hepatic disease that contraindicates the use of NSAIDs and/or Paracetamol.
- Allergy to amides local anesthesics, NSAIDs, opioids and/or Paracetamol.
- Daily use of opioids greater than 30 mg of morphine (or equivalent)
- Patients under 18 or over 90 years old.
- Drug abuse
- Rejection to be a participant of the study.
Sites / Locations
- Hospital Universitari Vall d'Hebron
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Femoral Nerve Block
Adductor Canal Block
Apex Femoral Triangle Block
Arm Description
Ultrasound guided femoral nerve block, 30 ml of 0.25% bupivacaine and 4 mg of dexamethasone to be administered.
Ultrasound guided adductor canal block, at the proximal third of the canal, 30 ml of 0.25% bupivacaine and 4 mg of dexamethasone to be administered.
Ultrasound guided femoral triangle block, at the distal third of the triangle, 30 ml of 0.25% bupivacaine and 4 mg of dexamethasone to be administered.
Outcomes
Primary Outcome Measures
Maximum voluntary isometric contraction (MVIC)
It measures quadriceps strength and is normalized to the body mass index (N * m/kg). This test correlates well with the functional outcome. Will be measured with standard handheld dynamometer (MicroFET2; Hoogan Industries, West Jordan, Utah) perpendicular to the tibial crest 5 cm proximal to the medial malleolus to make the measurement. The patients are told to "reach maximum force and hold for three seconds." Three measurements will be done, and the average will be taken.
The primary effectiveness endpoints of the study will be the percentage of baselineMVIC retained on the quadriceps of the leg receiving arthroplasty for each subject at 6 hours postoperatively.
A higher the percentage will relate with less motor block.
Secondary Outcome Measures
Timed Up and Go (TUG)
Timed Up and Go gauges a patient's sense of balance by measuring the time required for a certain set of movements: stand up from a chair, walk 3 m, walk back, and sit down. It has been verified to serve as a good indicator of functional level.
Measured in seconds, the better values are related to shorter times.
30' CST (30 secs Chair Stand Test)
How many times can a patient stand up and sit down from a chair in 30 seconds. The amount of times will be counted, more times will be related to a better outcome.
Range of Motion (ROM)
Range of motion refers to a knee's degree of extension or flexion and is measured via a goniometer. Considering normal values from 0-120º, the baseline movement will be measured preoperatively to be compared postoperatively.
Daniels' Test
Active extension of the knee against gravity and applied resistance (0-5). 5: normal contraction against gravity and maximal resistance. 0: abscence of contraction.
10-PMS (10 point Mobility Scale)
Scale from 0-10 in which the mobility of the patient is measured; sitting on the bed, chair, edge of the bed, mobilize the knee more than 45º, stand up, walk with or without a mobility aid.
Higher values are related to better outcomes.
An expected degree of flexion of the knee is ≥45 degrees on postoperative day 1 and ≥70 degrees on postoperative day 3.
Expected points for postoperative day 0: 4 points Expected points for postoperative day 1: 8 points Expected points for postoperative day 2: 9-10 points
Pain measurement trough the visual analogue scale (VAS)
Pain will be measured via the VAS pain score by having the patient point on an unmarked scale how their pain was and then translating it to millimeters on the 100-mm scale.
0 mm: no pain 100 mm: severe/extreme pain
Quantity of opioids administered
into morphine equivalent if needed.
APS-POQ-R.
Developed by an interdisciplinary task force of members of the American Pain Society, the Patient Outcome Questionnaire (APS-POQ) for QI has been revised to include instrument psychometrics. The article is available by open access at The Journal of Pain web site.
Patient satisfaction
Scale from 0 to 10, answering how do they feel about the treatment received, being 10 the maximum value related to the highest satisfaction level.
Length of hospital stay
Days from surgery until discharge.
Maximum voluntary isometric contraction (MVIC)
It measures quadriceps strength and is normalized to the body mass index (N * m/kg). This test correlates well with the functional outcome. Will be measured with standard handheld dynamometer (MicroFET2; Hoogan Industries, West Jordan, Utah) perpendicular to the tibial crest 5 cm proximal to the medial malleolus to make the measurement. The patients are told to "reach maximum force and hold for three seconds." Three measurements will be done, and the average will be taken.
The primary effectiveness endpoints of the study will be the percentage of baselineMVIC retained on the quadriceps of the leg receiving arthroplasty for each subject at 6, 24, and 48 hours postoperatively.
A higher the percentage will relate with less motor block.
Full Information
NCT ID
NCT03518450
First Posted
March 17, 2018
Last Updated
January 19, 2020
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03518450
Brief Title
Femoral Triangle Block: Early Mobilization and Postoperative Analgesia After Total Knee Arthroplasty
Official Title
Early Mobilization and Postoperative Analgesia After Total Knee Arthroplasty, a Prospective Comparative Study: Adductor Canal Block vs. Femoral Nerve Block vs. Apex Femoral Triangle Block
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 13, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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 objective of this trial is to compare the efficacy of three different nerve blocks as an analgesic option after total knee arthroplasty (TKA), based on muscle strength, mobilization and pain.
The Adductor Canal Block has been proposed as an equally effective technique to the Femoral Nerve Block in terms of pain control after a TKA, with the benefit of preserving muscle function. We hypothesize that a block performed at the apex of the femoral triangle would best balance analgesia with quadriceps function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Knee, Anesthesia, Conduction, Pain, Postoperative, Ultrasonography, Interventional
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Femoral Nerve Block
Arm Type
Active Comparator
Arm Description
Ultrasound guided femoral nerve block, 30 ml of 0.25% bupivacaine and 4 mg of dexamethasone to be administered.
Arm Title
Adductor Canal Block
Arm Type
Active Comparator
Arm Description
Ultrasound guided adductor canal block, at the proximal third of the canal, 30 ml of 0.25% bupivacaine and 4 mg of dexamethasone to be administered.
Arm Title
Apex Femoral Triangle Block
Arm Type
Experimental
Arm Description
Ultrasound guided femoral triangle block, at the distal third of the triangle, 30 ml of 0.25% bupivacaine and 4 mg of dexamethasone to be administered.
Intervention Type
Procedure
Intervention Name(s)
Apex Femoral Triangle Block
Intervention Description
Nerve block that aims the vastus medialis nerve, the saphenous nerve and the anterior femoral cutaneous nerve.
Intervention Type
Procedure
Intervention Name(s)
Femoral Nerve Block
Intervention Description
Regional anesthetic technique that blocks the sensory and motor information of the femoral nerve (and it's branches).
Intervention Type
Procedure
Intervention Name(s)
Adductor Canal Block
Intervention Description
Interfascial block that targets mainly the saphenous nerve.
Primary Outcome Measure Information:
Title
Maximum voluntary isometric contraction (MVIC)
Description
It measures quadriceps strength and is normalized to the body mass index (N * m/kg). This test correlates well with the functional outcome. Will be measured with standard handheld dynamometer (MicroFET2; Hoogan Industries, West Jordan, Utah) perpendicular to the tibial crest 5 cm proximal to the medial malleolus to make the measurement. The patients are told to "reach maximum force and hold for three seconds." Three measurements will be done, and the average will be taken.
The primary effectiveness endpoints of the study will be the percentage of baselineMVIC retained on the quadriceps of the leg receiving arthroplasty for each subject at 6 hours postoperatively.
A higher the percentage will relate with less motor block.
Time Frame
6 hours postoperatively
Secondary Outcome Measure Information:
Title
Timed Up and Go (TUG)
Description
Timed Up and Go gauges a patient's sense of balance by measuring the time required for a certain set of movements: stand up from a chair, walk 3 m, walk back, and sit down. It has been verified to serve as a good indicator of functional level.
Measured in seconds, the better values are related to shorter times.
Time Frame
6, 24 and 48 hours postoperatively.
Title
30' CST (30 secs Chair Stand Test)
Description
How many times can a patient stand up and sit down from a chair in 30 seconds. The amount of times will be counted, more times will be related to a better outcome.
Time Frame
6, 24 and 48 hours postoperatively.
Title
Range of Motion (ROM)
Description
Range of motion refers to a knee's degree of extension or flexion and is measured via a goniometer. Considering normal values from 0-120º, the baseline movement will be measured preoperatively to be compared postoperatively.
Time Frame
6, 24 and 48 hours postoperatively.
Title
Daniels' Test
Description
Active extension of the knee against gravity and applied resistance (0-5). 5: normal contraction against gravity and maximal resistance. 0: abscence of contraction.
Time Frame
6, 24 and 48 hours postoperatively.
Title
10-PMS (10 point Mobility Scale)
Description
Scale from 0-10 in which the mobility of the patient is measured; sitting on the bed, chair, edge of the bed, mobilize the knee more than 45º, stand up, walk with or without a mobility aid.
Higher values are related to better outcomes.
An expected degree of flexion of the knee is ≥45 degrees on postoperative day 1 and ≥70 degrees on postoperative day 3.
Expected points for postoperative day 0: 4 points Expected points for postoperative day 1: 8 points Expected points for postoperative day 2: 9-10 points
Time Frame
6, 24 and 48 hours postoperatively.
Title
Pain measurement trough the visual analogue scale (VAS)
Description
Pain will be measured via the VAS pain score by having the patient point on an unmarked scale how their pain was and then translating it to millimeters on the 100-mm scale.
0 mm: no pain 100 mm: severe/extreme pain
Time Frame
6, 24 and 48 hours postoperatively.
Title
Quantity of opioids administered
Description
into morphine equivalent if needed.
Time Frame
6, 24 and 48 hours postoperatively.
Title
APS-POQ-R.
Description
Developed by an interdisciplinary task force of members of the American Pain Society, the Patient Outcome Questionnaire (APS-POQ) for QI has been revised to include instrument psychometrics. The article is available by open access at The Journal of Pain web site.
Time Frame
At 24 hours postoperatively
Title
Patient satisfaction
Description
Scale from 0 to 10, answering how do they feel about the treatment received, being 10 the maximum value related to the highest satisfaction level.
Time Frame
24 and 48 hours postoperatively
Title
Length of hospital stay
Description
Days from surgery until discharge.
Time Frame
at patient discharge, an average of 6 days postoperatively
Title
Maximum voluntary isometric contraction (MVIC)
Description
It measures quadriceps strength and is normalized to the body mass index (N * m/kg). This test correlates well with the functional outcome. Will be measured with standard handheld dynamometer (MicroFET2; Hoogan Industries, West Jordan, Utah) perpendicular to the tibial crest 5 cm proximal to the medial malleolus to make the measurement. The patients are told to "reach maximum force and hold for three seconds." Three measurements will be done, and the average will be taken.
The primary effectiveness endpoints of the study will be the percentage of baselineMVIC retained on the quadriceps of the leg receiving arthroplasty for each subject at 6, 24, and 48 hours postoperatively.
A higher the percentage will relate with less motor block.
Time Frame
24 and 48 hours postoperatively.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects of any gender, from 18 to 90 years old that accept to participate in the study.
Programmed primary total knee arthroplasty surgery
Exclusion Criteria:
Emergent surgery
Reinterventions
Unstable psychiatric pathology, dementia
Kidney or hepatic disease that contraindicates the use of NSAIDs and/or Paracetamol.
Allergy to amides local anesthesics, NSAIDs, opioids and/or Paracetamol.
Daily use of opioids greater than 30 mg of morphine (or equivalent)
Patients under 18 or over 90 years old.
Drug abuse
Rejection to be a participant of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfons Biarnes Suñe, M.D., Ph.D.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carlos I Salvadores de Arzuaga, M.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25035824
Citation
Danninger T, Opperer M, Memtsoudis SG. Perioperative pain control after total knee arthroplasty: An evidence based review of the role of peripheral nerve blocks. World J Orthop. 2014 Jul 18;5(3):225-32. doi: 10.5312/wjo.v5.i3.225. eCollection 2014 Jul 18.
Results Reference
background
PubMed Identifier
27015172
Citation
Dong CC, Dong SL, He FC. Comparison of Adductor Canal Block and Femoral Nerve Block for Postoperative Pain in Total Knee Arthroplasty: A Systematic Review and Meta-analysis. Medicine (Baltimore). 2016 Mar;95(12):e2983. doi: 10.1097/MD.0000000000002983.
Results Reference
background
PubMed Identifier
20966667
Citation
Paul JE, Arya A, Hurlburt L, Cheng J, Thabane L, Tidy A, Murthy Y. Femoral nerve block improves analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials. Anesthesiology. 2010 Nov;113(5):1144-62. doi: 10.1097/ALN.0b013e3181f4b18.
Results Reference
background
PubMed Identifier
11402405
Citation
Chelly JE, Greger J, Gebhard R, Coupe K, Clyburn TA, Buckle R, Criswell A. Continuous femoral blocks improve recovery and outcome of patients undergoing total knee arthroplasty. J Arthroplasty. 2001 Jun;16(4):436-45. doi: 10.1054/arth.2001.23622.
Results Reference
background
PubMed Identifier
19680735
Citation
Sharma S, Iorio R, Specht LM, Davies-Lepie S, Healy WL. Complications of femoral nerve block for total knee arthroplasty. Clin Orthop Relat Res. 2010 Jan;468(1):135-40. doi: 10.1007/s11999-009-1025-1. Epub 2009 Aug 13.
Results Reference
background
PubMed Identifier
27015545
Citation
Burckett-St Laurant D, Peng P, Giron Arango L, Niazi AU, Chan VW, Agur A, Perlas A. The Nerves of the Adductor Canal and the Innervation of the Knee: An Anatomic Study. Reg Anesth Pain Med. 2016 May-Jun;41(3):321-7. doi: 10.1097/AAP.0000000000000389.
Results Reference
background
PubMed Identifier
26938989
Citation
Abdallah FW, Whelan DB, Chan VW, Prasad GA, Endersby RV, Theodoropolous J, Oldfield S, Oh J, Brull R. Adductor Canal Block Provides Noninferior Analgesia and Superior Quadriceps Strength Compared with Femoral Nerve Block in Anterior Cruciate Ligament Reconstruction. Anesthesiology. 2016 May;124(5):1053-64. doi: 10.1097/ALN.0000000000001045.
Results Reference
background
PubMed Identifier
27007076
Citation
Elkassabany NM, Antosh S, Ahmed M, Nelson C, Israelite C, Badiola I, Cai LF, Williams R, Hughes C, Mariano ER, Liu J. The Risk of Falls After Total Knee Arthroplasty with the Use of a Femoral Nerve Block Versus an Adductor Canal Block: A Double-Blinded Randomized Controlled Study. Anesth Analg. 2016 May;122(5):1696-703. doi: 10.1213/ANE.0000000000001237.
Results Reference
background
PubMed Identifier
28002228
Citation
Wong WY, Bjorn S, Strid JM, Borglum J, Bendtsen TF. Defining the Location of the Adductor Canal Using Ultrasound. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):241-245. doi: 10.1097/AAP.0000000000000539.
Results Reference
background
PubMed Identifier
26678763
Citation
Kardash KJ, Noel GP. The SPANK Block: A Selective Sensory, Single-Injection Solution for Posterior Pain After Total Knee Arthroplasty. Reg Anesth Pain Med. 2016 Jan-Feb;41(1):118-9. doi: 10.1097/AAP.0000000000000330. No abstract available.
Results Reference
background
PubMed Identifier
23241723
Citation
Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
Results Reference
background
PubMed Identifier
27685346
Citation
Bendtsen TF, Moriggl B, Chan V, Borglum J. The Optimal Analgesic Block for Total Knee Arthroplasty. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):711-719. doi: 10.1097/AAP.0000000000000485.
Results Reference
background
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Femoral Triangle Block: Early Mobilization and Postoperative Analgesia After Total Knee Arthroplasty
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