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

Not Applicable

Completed

• Conditions: Anesthesia, Conduction; Pain, Postoperative; Ultrasonography, Interventional; Arthroplasty, Replacement, Knee
• Interventions: Procedure: Femoral Nerve Block; Procedure: Adductor Canal Block; Procedure: Apex Femoral Triangle Block

• Registration Number: NCT03518450
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-17
• Study Start: 2018-04-01
• Study First Submitted QC: 2018-05-05
• Study First Posted: 2018-05-08
• Primary Completion: 2019-04-13
• Study Completion: 2019-10-15
• Status Verified: 2019-11
• Last Update Submitted: 2020-01-19
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral Nerve Block	Femoral Nerve Block	Ultrasound guided femoral nerve block, 30 ml of 0.25% bupivacaine and 4 mg of dexamethasone to be administered.
Adductor Canal Block	Adductor Canal Block	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.
Apex Femoral Triangle Block	Apex Femoral Triangle Block	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.

Primary Outcome Measures

Name	Time	Method
Maximum voluntary isometric contraction (MVIC)	6 hours postoperatively	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

Name	Time	Method
30' CST (30 secs Chair Stand Test)	6, 24 and 48 hours postoperatively.	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.
Quantity of opioids administered	6, 24 and 48 hours postoperatively.	into morphine equivalent if needed.
APS-POQ-R.	At 24 hours postoperatively	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.
Pain measurement trough the visual analogue scale (VAS)	6, 24 and 48 hours postoperatively.	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
Maximum voluntary isometric contraction (MVIC)	24 and 48 hours postoperatively.	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.
Timed Up and Go (TUG)	6, 24 and 48 hours postoperatively.	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.
Range of Motion (ROM)	6, 24 and 48 hours postoperatively.	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	6, 24 and 48 hours postoperatively.	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)	6, 24 and 48 hours postoperatively.	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
Patient satisfaction	24 and 48 hours postoperatively	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	at patient discharge, an average of 6 days postoperatively	Days from surgery until discharge.

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain