Femoral Triangle and Adductor Canal Blocks Versus Femoral Nerve Block for Total Knee Arthroplasty

NCT03645954 | Completed Results

• 1 other identifier: BEC-MF-172
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, double-blinded, randomized controlled study evaluates effects of femoral triangle and adductor canal blocks in comparison with femoral nerve block for primary total knee arthroplasty. Patients undergoing primary total knee arthroplasty will be randomly assigned to receive either femoral triangle and adductor canal blocks or femoral nerve block. Comparison of these two groups of patients will be based on the effects on postoperative pain control, extent of motor blockade, ability of early ambulation, patients satisfaction rates over the time of clinical recovery and the length of hospitalization. To the investigator's knowledge, no comparison has been made between femoral triangle and adductor canal blocks and femoral nerve block or any other block. Consequently, we hypothesized that femoral triangle and adductor canal blocks and femoral nerve block provide similar effects on postoperative pain control, but femoral triangle and adductor canal blocks are superior to femoral nerve block in terms of early postoperative mobilization.

Conditions

Total Knee Arthroplasty

Keywords

Femoral triangle block; Adductor canal block; Femoral nerve block; Primary total knee arthroplasty; Pain management; Functional recovery

Outcome Measures

Primary Outcomes (2)

• Extent of Motor Blockade

  The extent of postoperative motor blockade will be evaluated using Bromage scale: Grade I - free movement of legs and feet, Grade II - just able to flex knees with free movement of feet, Grade III - unable to flex knees, but with free movement of feet, Grade IV - unable to move legs or feet. It will be assessed at 3, 6, 24, 48 hours after surgery.

  3, 6, 24, 48 hours after primary total knee arthroplasty.

• Postoperative Pain Intensity and Pain Control

  Postoperative pain intensity and pain control will be assessed in both groups using visual analogue scale (VAS). VAS scale is consisted of a scale from 0 (no pain) to 10 (worst imaginable pain). Pain control and pain intensity will be assessed at rest, during active and passive 45 degree knee flexion at 3, 6, 24, 48 hours after surgery.

  3, 6, 24, 48 hours after primary total knee arthroplasty.

Secondary Outcomes (4)

• Ability of Early Ambulation After Surgery

  24, 48 hours after primary total knee arthroplasty.

• Number of Participants Needing Additional Opioids

  3, 6, 24, 48 hours after primary total knee arthroplasty.

• Rate of Patients Satisfaction

  3, 6, 24, 48 hours after primary total knee arthroplasty.

• Number of Participants With Nausea or Vomiting

  3, 6, 24, 48 hours after primary total knee arthroplasty.

Study Arms (2)

Femoral Nerve Block

ACTIVE COMPARATOR

The femoral nerve block will be performed under the ultrasound guidance by a single injection of local anesthetic around all the femoral nerve branches inside the proximal part of the femoral triangle.

Procedure: Femoral Nerve Block

Femoral Triangle & Adductor Canal Blocks

ACTIVE COMPARATOR

These two blocks will be performed together. Firstly, the femoral triangle block will be performed under the ultrasound guidance by a single injection of local anesthetic at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle. Local anesthetic will be injected laterally to the femoral artery. Secondly, the adductor canal block will be performed under the ultrasound guidance by a single injection of local anesthetic at the level where the femoral vessels (artery and vein) dive deeper from the sartorius muscle. Local anesthetic will be injected under the femoral artery.

Procedure: Femoral Triangle & Adductor Canal Blocks

Interventions

Femoral Nerve Block PROCEDURE

Procedure: Femoral Nerve Block The femoral nerve block will be performed as described in Arms section. Device: Ultrasound Linear ultrasound transducer probe (Flex Focus 400 exp, bk medical, Denmark) will be used to guide the needle placement. Device: Needle 20-gauge 50 mm Ultraplex needle (B. Braun Medical Inc., Melsungen, Germany) will be used to perform the femoral nerve block. Drug: Local anesthetic Bupivacaine 0.125% 20 mL will be used to perform the femoral nerve block.

Femoral Nerve Block

Femoral Triangle & Adductor Canal Blocks PROCEDURE

Procedure: Femoral Triangle \& Adductor Canal Blocks These two blocks will be performed as described in Arms section. Device: Ultrasound Linear ultrasound transducer probe (Flex Focus 400 exp, bk medical, Denmark) will be used to guide the needle placement. Device: Needle 20-gauge 100 mm Ultraplex needle (B. Braun Medical Inc., Melsungen, Germany) will be used to perform the femoral triangle block and adductor canal block. Drug: Local anesthetic Bupivacaine 0.125% 20 mL will be used to perform the femoral triangle block and adductor canal block (10 mL for each block).

Femoral Triangle & Adductor Canal Blocks

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary unilateral total knee arthroplasty under the spinal anesthesia.
• Age 18 - 90 years.
• Patients conformed to American Society of Anesthesiologists (ASA) physical status I-III in preoperative assessment.
• Ability to follow the study protocol.

You may not qualify if:

• Inability or refusal to follow the study protocol.
• American Society of Anesthesiologists (ASA) physical status classification of IV or higher.
• Coagulopathy.
• Pre-existing lower extremity neuromuscular disorders.
• Local infection over the injection site.
• Allergy or contraindications to the drugs used in the study (local anesthetics, NSAIDs, opioids).
• Chronic opioid use.
• Other type of anesthesia.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences Kauno Klinikos, Department of Anesthesiology

Kaunas, Lithuania

Location

Related Publications (6)

• 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: 27685346 BACKGROUND

• Kuang MJ, Ma JX, Fu L, He WW, Zhao J, Ma XL. Is Adductor Canal Block Better Than Femoral Nerve Block in Primary Total Knee Arthroplasty? A GRADE Analysis of the Evidence Through a Systematic Review and Meta-Analysis. J Arthroplasty. 2017 Oct;32(10):3238-3248.e3. doi: 10.1016/j.arth.2017.05.015. Epub 2017 May 17.

  PMID: 28606458 BACKGROUND

• Grevstad U, Mathiesen O, Lind T, Dahl JB. Effect of adductor canal block on pain in patients with severe pain after total knee arthroplasty: a randomized study with individual patient analysis. Br J Anaesth. 2014 May;112(5):912-9. doi: 10.1093/bja/aet441. Epub 2014 Jan 8.

  PMID: 24401802 BACKGROUND

• Seo SS, Kim OG, Seo JH, Kim DH, Kim YG, Park BY. Comparison of the Effect of Continuous Femoral Nerve Block and Adductor Canal Block after Primary Total Knee Arthroplasty. Clin Orthop Surg. 2017 Sep;9(3):303-309. doi: 10.4055/cios.2017.9.3.303. Epub 2017 Aug 4.

  PMID: 28861197 BACKGROUND

• Koh IJ, Choi YJ, Kim MS, Koh HJ, Kang MS, In Y. Femoral Nerve Block versus Adductor Canal Block for Analgesia after Total Knee Arthroplasty. Knee Surg Relat Res. 2017 Jun 1;29(2):87-95. doi: 10.5792/ksrr.16.039.

  PMID: 28545172 BACKGROUND

• 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: 27015172 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

There is no control group of patients who would not receive any peripheral nerve block. We were not able to measure the quadriceps muscle strenght with a dynamometer.

Results Point of Contact

• Title: Principal Investigator Inna Jaremko
• Organization: Lithuanian Univrsity of Health Sciences

inna.jaremko@kaunoklinikos.lt

+37064857386

Study Officials

• Arunas Gelmanas, MDPhDAssProf

  Lithuanian University of Health Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 24, 2018
• Study Start: August 28, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: February 3, 2021
• Results First Posted: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)