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Total Knee ArthroplastyNCT03645954

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

A study testing Femoral Nerve Block and Femoral Triangle & Adductor Canal Blocks in people with Total Knee Arthroplasty, run by Lithuanian University of Health Sciences at 1 site in Lithuania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Total Knee Arthroplasty
What is being tested?
Femoral Nerve Block and Femoral Triangle & Adductor Canal Blocks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteLithuania
Study dates
28 Aug 2018to 31 May 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Lithuania1 site
  • Lithuanian University of Health Sciences Kauno Klinikos, Department of Anesthesiology

    Kaunas

Other trials in Lithuania

About this study

Official title: Femoral Triangle and Adductor Canal Blocks Versus Femoral Nerve Block for Total Knee Arthroplasty: Postoperative Pain Management and Functional Recovery

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.

Read the detailed description

The aim: to evaluate femoral triangle and adductor canal blocks and femoral nerve block regarding the postoperative analgesic efficacy, extent of motor blockade, ability of early ambulation in patients following primary total knee arthroplasty.

Primary Hypothesis: femoral triangle and adductor canal blocks and femoral nerve block provide similar postoperative pain relieving effect after primary total knee arthroplasty.

Secondary Effects: femoral triangle and adductor canal blocks provide better ability of early ambulation after primary total knee arthroplasty.

The objectives:

  1. To compare postoperative pain control effects between femoral triangle and adductor canal blocks and femoral nerve block groups of patients after primary total knee joint replacement surgery.
  2. To assess the ability of early ambulation and extent of motor blockade after primary total knee joint replacement surgery between the groups of patients.
  3. To estimate opioid consumption and its adverse effects in femoral triangle and adductor canal blocks and femoral nerve block groups of patients after primary total knee arthroplasty.
  4. To compare patients postoperative satisfaction rates between femoral triangle and adductor canal blocks and femoral nerve block groups of patients after primary total knee arthroplasty.

Methods:

The prospective, double-blinded study includes American Society of Anesthesiologists (ASA) physical status I-III in preoperative assessment, aged 18-90 years, admitted for primary total knee arthroplasty. Preoperatively patients will be blindly randomized into one of two groups: femoral triangle and adductor canal blocks group and femoral nerve block group. Group assignment will be concealed by opaque envelopes that will be opened only after the enrollment. The anesthesiologist performing the block will be aware of the treatment, but the participant and outcomes assessor will be blinded to the group assignment.

All blocks will be performed by the anesthesiologist under the guidance of a linear ultrasound transducer probe. Femoral nerve block will be performed at the proximal part of the femoral triangle by 20 mL of 0.125% bupivacaine injection. Femoral triangle and adductor canal blocks will be performed together. Femoral triangle block will be performed at the level where the medial border of the sartorius muscle intersects the medial border of the adductor longus muscle with injection of 10 mL of 0.125% bupivacaine. Local anesthetic will be injected laterally to the femoral artery. Adductor canal block will be performed at the level where the femoral vessels (artery and vein) dive deeper from the sartorius muscle with injection of 10 mL of 0.125% bupivacaine. Local anesthetic will be injected under the femoral artery.

During the perioperative period all patients from both groups will receive a standardized anesthetic and analgesic. Premedication of midazolam 2.5-5 mg and dexamethasone 4 mg will be given to all patients and a slow fluid infusion of crystalloids with 1 g of tranexamic acid and 10 mg of ketamine will be started once as an intravenous cannula will be placed. Spinal anesthesia after identification of the subarachnoid space will be performed with 15 mg of levobupivacaine. After that, femoral triangle and adductor canal blocks or femoral nerve block (depending on the group of patients) will be performed under the ultrasound guidance. Patients will be sedated with intravenously administered propofol during the surgery. The local infiltration analgesia will be performed by the surgeon at the end of surgery with combination of 30 mL of 0.5% bupivacaine, 0.3 mL of 0.1% adrenaline and 90 mL of 0.9% sodium chloride. After the surgery patients will be transferred to the post-anesthesia care unit (PACU).

During the postoperative period for analgesia NSAIDs will be available to both groups of patients. NSAIDs such as dexketoprofen 50 mg will be administered 2 times and acetaminophen 1 g will be administered 3 times per day. Opioids will also be available to patients as intramuscular boluses of pethidine 50 mg or morphine 10 mg without restriction and administered for moderate or severe pain (VAS pain score of 5 or greater out of 10).

Postoperative pain control efficacy will be assessed at 3, 6, 24 and 48 hours after surgery using visual analogue scale (VAS) from 0 to 10 (0 - no pain, 10 - worst imaginable pain) at rest, during active and passive 45 degree knee flexion. The requirement of additional analgesics and their adverse effects (if any) will be recorded.

The extent of motor blockade will be evaluated at 3, 6, 24, 48 hours after surgery. Patients will be asked to flex the foot, to flex the knee and to lift up the straight leg. The possible leg motion at 3, 6, 24 and 48 hours postoperatively will be assessed with Bromage scale grades: 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.

Patients ability of early ambulation will be evaluated using Timed Up and Go (TUG) test at 24 and 48 hours after surgery. To do the TUG test, patients will have to sit down on the bed, get up from the bed, walk 3 meters forward, turn, walk back 3 meters to the bed and sit down. The time taken by a patient to perform this test will be calculated with a chronometer.

After the conversation with each patient and assessment of postoperative pain control efficacy, extent of motor blockade, ability of early ambulation, the rate of patient satisfaction will be evaluated using a 10 point scale from 0 (completely unsatisfied) to 10 (totally satisfied) at 3, 6, 24, 48 hours after surgery.

The length of hospital stay and rate of complications (if any), including falls, local anesthetic toxicity or neurological complications, will be recorded in both groups of patients.

According to study protocol, both groups of patients will be compared in terms of postoperative pain control, opioid consumption, extent of motor blockade, ability of early ambulation, patients satisfaction rates over the time of clinical recovery and the length of hospitalization.

Being tested
Femoral Nerve Block, Femoral Triangle & Adductor Canal Blocks
Keywords
Femoral triangle block, Adductor canal block, Femoral nerve block, Primary total knee arthroplasty, Pain management, Functional recovery
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Femoral Nerve BlockProcedure or surgery

    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 Triangle & Adductor Canal BlocksProcedure or surgery

    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).

Study groups in NCT03645954
Study groupRoleWhat they receive
Femoral Nerve BlockActive comparatorThe 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.
Receives: Procedure: Femoral Nerve Block
Femoral Triangle & Adductor Canal BlocksActive comparatorThese 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.
Receives: Procedure: Femoral Triangle & Adductor Canal Blocks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (4)
  1. Ability of Early Ambulation After Surgery

    Postoperative ability of early ambulation will be assessed using Timed Up and Go (TUG) test. The TUG test measures the time it takes the patient to get up from a bed, walk 3 meters, turn, walk back to the bed and sit down. The TUG test results will be evaluated at 24 and 48 hours after surgery.

    Measured: 24, 48 hours after primary total knee arthroplasty.

  2. Number of Participants Needing Additional Opioids

    The need of additional opioids will be recorded at 3, 6, 24 and 48 hours after surgery in both groups.

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

  3. Rate of Patients Satisfaction

    Patient satisfaction rates will be evaluated using a 10 point scale from 0 (completely unsatisfied) to 10 (totally satisfied) at 3, 6, 24, 48 hours after surgery.

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

  4. Number of Participants With Nausea or Vomiting

    The number of patients with nausea and vomiting will be evaluated in both groups of patients.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2018
  2. Study start28 Aug 2018
  3. Primary completion31 May 2019
  4. Study completion31 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03645954
Sponsor's protocol ID
BEC-MF-172
Status last verified
Jan 2021
First submitted
15 Aug 2018
Last updated
3 Feb 2021
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27685346
  • 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.

    PubMed 28606458
  • 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.

    PubMed 24401802
  • 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.

    PubMed 28861197
  • 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.

    PubMed 28545172
  • 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.

    PubMed 27015172

Questions about this trial

What is this clinical trial studying?

A study testing Femoral Nerve Block and Femoral Triangle & Adductor Canal Blocks in people with Total Knee Arthroplasty, run by Lithuanian University of Health Sciences at 1 site in Lithuania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extent of Motor Blockade (time frame: 3, 6, 24, 48 hours after primary total knee arthroplasty.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03645954, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.

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