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Completed

NCT Number: NCT03518450

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

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.

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Key information

Conditions

Arthroplasty, Replacement, Knee Anesthesia, Conduction Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Ultrasonography, Interventional

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apex Femoral Triangle Block

Procedure

Nerve block that aims the vastus medialis nerve, the saphenous nerve and the anterior femoral cutaneous nerve.

Femoral Nerve Block

Procedure

Regional anesthetic technique that blocks the sensory and motor information of the femoral nerve (and it's branches).

Adductor canal block

Procedure

Interfascial block that targets mainly the saphenous nerve.

Primary outcomes

  1. Maximum voluntary isometric contraction (MVIC)

    Time frame: 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 outcomes

  1. Timed Up and Go (TUG)

    Time frame: 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.

  2. 30' CST (30 secs Chair Stand Test)

    Time frame: 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.

  3. Range of Motion (ROM)

    Time frame: 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.

  4. Daniels' Test

    Time frame: 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.

  5. 10-PMS (10 point Mobility Scale)

    Time frame: 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

  6. Pain measurement trough the visual analogue scale (VAS)

    Time frame: 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

  7. Quantity of opioids administered

    Time frame: 6, 24 and 48 hours postoperatively.

    into morphine equivalent if needed.

  8. APS-POQ-R.

    Time frame: 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.

  9. Patient satisfaction

    Time frame: 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.

  10. Length of hospital stay

    Time frame: at patient discharge, an average of 6 days postoperatively

    Days from surgery until discharge.

  11. Maximum voluntary isometric contraction (MVIC)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 8, 2018
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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