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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518450
• Other study ID #: PR(AG)299/2017
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: October 15, 2019

Study information

• Verified date: November 2019
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 15, 2019
• Est. primary completion date: April 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Conduction
• Arthroplasty, Replacement, Knee
• Pain, Postoperative
• Ultrasonography, Interventional

Intervention

Procedure:
• Apex Femoral Triangle Block
Nerve block that aims the vastus medialis nerve, the saphenous nerve and the anterior femoral cutaneous nerve.
• Femoral Nerve Block
Regional anesthetic technique that blocks the sensory and motor information of the femoral nerve (and it's branches).
• Adductor Canal Block
Interfascial block that targets mainly the saphenous nerve.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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. — View Citation

Bendtsen TF, Moriggl B, Chan V, Børglum J. The Optimal Analgesic Block for Total Knee Arthroplasty. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):711-719. — View Citation

Burckett-St Laurant D, Peng P, Girón 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Wong WY, Bjørn S, Strid JM, Børglum 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Timed Up and Go (TUG)	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.	6, 24 and 48 hours postoperatively.
Secondary	30' CST (30 secs Chair Stand Test)	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.	6, 24 and 48 hours postoperatively.
Secondary	Range of Motion (ROM)	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.	6, 24 and 48 hours postoperatively.
Secondary	Daniels' Test	Active extension of the knee against gravity and applied resistance (0-5). 5: normal contraction against gravity and maximal resistance. 0: abscence of contraction.	6, 24 and 48 hours postoperatively.
Secondary	10-PMS (10 point Mobility Scale)	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, 24 and 48 hours postoperatively.
Secondary	Pain measurement trough the visual analogue scale (VAS)	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	6, 24 and 48 hours postoperatively.
Secondary	Quantity of opioids administered	into morphine equivalent if needed.	6, 24 and 48 hours postoperatively.
Secondary	APS-POQ-R.	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.	At 24 hours postoperatively
Secondary	Patient satisfaction	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.	24 and 48 hours postoperatively
Secondary	Length of hospital stay	Days from surgery until discharge.	at patient discharge, an average of 6 days postoperatively
Secondary	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, 24, and 48 hours postoperatively.; A higher the percentage will relate with less motor block.	24 and 48 hours postoperatively.