NCT03518450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
Last Updated

January 22, 2020

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

March 17, 2018

Last Update Submit

January 19, 2020

Conditions

Arthroplasty, Replacement, KneeAnesthesia, ConductionPain, PostoperativeUltrasonography, Interventional

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 hours postoperatively

Secondary Outcomes (11)

  • 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.

  • +6 more secondary outcomes

Study Arms (3)

Femoral Nerve Block

ACTIVE COMPARATOR

Ultrasound guided femoral nerve block, 30 ml of 0.25% bupivacaine and 4 mg of dexamethasone to be administered.

Procedure: Femoral Nerve Block

Adductor Canal Block

ACTIVE COMPARATOR

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.

Procedure: Adductor Canal Block

Apex Femoral Triangle Block

EXPERIMENTAL

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.

Procedure: Apex Femoral Triangle Block

Interventions

Apex Femoral Triangle BlockPROCEDURE

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

Apex Femoral Triangle Block
Femoral Nerve BlockPROCEDURE

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

Femoral Nerve Block
Adductor Canal BlockPROCEDURE

Interfascial block that targets mainly the saphenous nerve.

Adductor Canal Block

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects of any gender, from 18 to 90 years old that accept to participate in the study.
  • Programmed primary total knee arthroplasty surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (13)

  • 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.

    PMID: 25035824BACKGROUND

  • 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.

    PMID: 27015172BACKGROUND

  • 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.

    PMID: 20966667BACKGROUND

  • 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.

    PMID: 11402405BACKGROUND

  • 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.

    PMID: 19680735BACKGROUND

  • 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.

    PMID: 27015545BACKGROUND

  • 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.

    PMID: 26938989BACKGROUND

  • 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.

    PMID: 27007076BACKGROUND

  • 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.

    PMID: 28002228BACKGROUND

  • 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.

    PMID: 26678763BACKGROUND

  • 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.

    PMID: 23241723BACKGROUND

  • 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.

    PMID: 27685346BACKGROUND

  • de Arzuaga CIS, Miguel M, Biarnes A, Garcia M, Naya J, Khoudeir A, Minguell J, Pujol O. Single-injection nerve blocks for total knee arthroplasty: femoral nerve block versus femoral triangle block versus adductor canal block-a randomized controlled double-blinded trial. Arch Orthop Trauma Surg. 2023 Nov;143(11):6763-6771. doi: 10.1007/s00402-023-04960-5. Epub 2023 Jun 30.

    PMID: 37391523DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Alfons Biarnes Suñe, M.D., Ph.D.

    STUDY DIRECTOR

  • Carlos I Salvadores de Arzuaga, M.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2018

First Posted

May 8, 2018

Study Start

April 1, 2018

Primary Completion

April 13, 2019

Study Completion

October 15, 2019

Last Updated

January 22, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)