Femoral Triangle Block: Early Mobilization and Postoperative Analgesia After Total Knee Arthroplasty

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Apex Femoral Triangle Block

Femoral Nerve Block

Adductor Canal Block

About this trial

This is an interventional treatment trial for Arthroplasty, Replacement, Knee

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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