Clinical trial NCT03518450: 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
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Anesthesia, Conduction
Pain, Postoperative
Ultrasonography, Interventional
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Maximum voluntary isometric contraction (MVIC)
timeFrame: 6 hours postoperatively
Secondary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: 6, 24 and 48 hours postoperatively.
measure: 30' CST (30 secs Chair Stand Test)
timeFrame: 6, 24 and 48 hours postoperatively.
measure: Range of Motion (ROM)
timeFrame: 6, 24 and 48 hours postoperatively.
measure: Daniels' Test
timeFrame: 6, 24 and 48 hours postoperatively.
measure: 10-PMS (10 point Mobility Scale)
timeFrame: 6, 24 and 48 hours postoperatively.
measure: Pain measurement trough the visual analogue scale (VAS)
timeFrame: 6, 24 and 48 hours postoperatively.
measure: Quantity of opioids administered
timeFrame: 6, 24 and 48 hours postoperatively.
measure: APS-POQ-R.
timeFrame: At 24 hours postoperatively
measure: Patient satisfaction
timeFrame: 24 and 48 hours postoperatively
measure: Length of hospital stay
timeFrame: at patient discharge, an average of 6 days postoperatively
measure: Maximum voluntary isometric contraction (MVIC)
timeFrame: 24 and 48 hours postoperatively.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
name: Alfons Biarnes Suñe, M.D., Ph.D.
role: STUDY_DIRECTOR
name: Carlos I Salvadores de Arzuaga, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.