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Clinical Trials/NCT03518450
NCT03518450
Completed
Not Applicable

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

Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country78 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthroplasty, Replacement, Knee
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
78
Locations
1
Primary Endpoint
Maximum voluntary isometric contraction (MVIC)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
October 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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.

Outcomes

Primary Outcomes

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

  • Quantity of opioids administered(6, 24 and 48 hours postoperatively.)
  • APS-POQ-R.(At 24 hours postoperatively)
  • Pain measurement trough the visual analogue scale (VAS)(6, 24 and 48 hours postoperatively.)
  • Maximum voluntary isometric contraction (MVIC)(24 and 48 hours postoperatively.)
  • Timed Up and Go (TUG)(6, 24 and 48 hours postoperatively.)
  • 30' CST (30 secs Chair Stand Test)(6, 24 and 48 hours postoperatively.)
  • Range of Motion (ROM)(6, 24 and 48 hours postoperatively.)
  • Daniels' Test(6, 24 and 48 hours postoperatively.)
  • 10-PMS (10 point Mobility Scale)(6, 24 and 48 hours postoperatively.)
  • Patient satisfaction(24 and 48 hours postoperatively)
  • Length of hospital stay(at patient discharge, an average of 6 days postoperatively)

Study Sites (1)

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