Femoral Triangle Block With Popliteal Plexus Block Versus Femoral Triangle Block Versus Adductor Canal Block for TKA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-09

Study Completion Date

2023-06-26

Brief Summary

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In this study we wish to investigate the analgesic effect 3 different nerve block regimes in patients following primary total knee arthroplasty (TKA). All nerve blocks were performed as single shot blocks with the administration of Marcain 5 mg/ml.

Regime A: proximal Femoral Triangle Block (FTB) with 10 ml including Intermediate Femoral Cutaneous Nerve Block (IFCNB) with 5 ml + Popliteal Plexus Block (PPB) with 10 ml.

Regime B: proximal FTB with 10 ml including IFCNB with 5 ml.

Regime C: Adductor Canal Block (ACB) with 25 ml.

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Detailed Description

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The Adductor Canal Block (ACB) is frequently used after TKA, but it is limited to provide anesthesia from the anteromedial part of the knee region. The proximal Femoral Triangle Block (FTB) is also used for TKA, and also limited to provide anesthesia from the anterior medial part of the knee joint. The FTB anesthetize the saphenus nerve, the nerve to vastus medialis, and may anesthetize the medial femoral cutaneous nerve which innervates the distal medial thigh as well as the anteromedial knee region. We included the Intermediate Femoral Cutaneous Nerve block (IFCNB) in the FTB, as the nerves can be targeted in the subcutis on the anterior thigh and easily be anesthetized during the same procedure as FTB. IFCNB anesthetize the distal anterior thigh, which may include the proximal part of the surgical incision for TKA. In the following text the proximal FTB including IFCNB will be refered as "FTB" and the dose of 15 ml will refer to 10 ml for the proximal FTB and 5 ml used for the IFCNB.

A new nerve block technique, called Popliteal Plexus Block (PPB), is specifically designed to anaesthetize nerves involved in innervation of the back of the knee joint. The analgesic effect of PPB has not yet been evaluated in randomized, controlled, blinded trials. In order to optimize pain treatment for primary TKA by improving the pain-relieving effect of peripheral nerve blocks, we aim to evaluate the analgesic effects of three different nerve block regimens (FTB + PPB versus FTB versus ACB) after primary unilateral TKA. Our outcomes include postoperative pain scores, opioid consumption, muscle strength and mobilization.

Our hypothesis is that the combination of FTB + PPB provides superior postoperative pain treatment after TKA in comparison to both FTB or ACB. The combination of FTB + PPB will reduce opioid consumption (primary outcome) and postoperative pain scores without reducing muscle strength or impairing mobilization.

Conditions

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Pain, Acute Opioid Use Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients assigned for total knee arthroplasty are randomized into one of the three study groups in accordance to a computer-generated block randomization list in a 1:1:1 ratio (each block containing 15 numbers). Prior to surgery the patients receive the peripheral nerve blocks allocated to the group/arm they belong to:

Group A: FTB (active) + ACB (sham) + PPB (active) Group B: FTB (active) + ACB (sham) + PPB (sham) Group C: FTB (sham) + ACB (active) + PPB (sham)

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Three unblinded anesthesiologists, including the sponsor, are responsible for performing the peripheral nerve block and will not be involved in any clinical assessments, data collection or interpretation of adverse events.

During the nerve block procedure, an opaque cloth hung over the stomach level, prevents the patient for monitoring block procedure and the ultrasound monitor. All patients experience three needle insertions in the skin (one for PPB, one for FTB incl. IFCN and one for ACB). The same time is used for each needle insertion, regardless of injection of active drug (active nerve block) or simulation of injection (sham block). Most patient are sensible to the needle insertion but are not able to feel the injection of local anesthetics. All this will ensure that the patient is blinded.

None of the blinded outcome assessors, including primary investigator, are present during the opening of the randomization or during the nerve block procedure.

Study Groups

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Group A: Active FTB + Active PPB + Sham ACB

Single shot bolus of 10 ml Marcain 5 mg/ml is used for FTB, 5 ml Marcain 5 mg/ml for IFCN + 10 ml Marcain 5 mg/ml is used for PPB

Group Type ACTIVE_COMPARATOR

Marcain 5 mg/ml

Intervention Type DRUG

Total volumes of Marcain differs in each arm, depending on which nerve blocks the patients is randomized to receive. Sham block does not include injection of placebo saline, due to the risk of hydrodissection between the anatomical sections which may erase the isolation of the different nerve blocks. Instead the sham block include imitation of the real nerve block, including correct placement of the needle on the target for the block.

Group B: Active FTB + Sham PPB + Sham ACB

Single shot bolus of 10 ml Marcain 5 mg/ml is used for FTB, 5 ml Marcain 5 mg/ml is used for IFCN

Group Type ACTIVE_COMPARATOR

Marcain 5 mg/ml

Intervention Type DRUG

Total volumes of Marcain differs in each arm, depending on which nerve blocks the patients is randomized to receive. Sham block does not include injection of placebo saline, due to the risk of hydrodissection between the anatomical sections which may erase the isolation of the different nerve blocks. Instead the sham block include imitation of the real nerve block, including correct placement of the needle on the target for the block.

Group C: Sham FTB + Sham PPB + Active ACB

Single shot bolus of 25 ml Marcain 5 mg/ml is used for ACB

Group Type ACTIVE_COMPARATOR

Marcain 5 mg/ml

Intervention Type DRUG

Total volumes of Marcain differs in each arm, depending on which nerve blocks the patients is randomized to receive. Sham block does not include injection of placebo saline, due to the risk of hydrodissection between the anatomical sections which may erase the isolation of the different nerve blocks. Instead the sham block include imitation of the real nerve block, including correct placement of the needle on the target for the block.

Interventions

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Marcain 5 mg/ml

Total volumes of Marcain differs in each arm, depending on which nerve blocks the patients is randomized to receive. Sham block does not include injection of placebo saline, due to the risk of hydrodissection between the anatomical sections which may erase the isolation of the different nerve blocks. Instead the sham block include imitation of the real nerve block, including correct placement of the needle on the target for the block.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Scheduled to undergo primary total knee arthroplasty in spinal anesthesia
* Able to perform a Timed Up and Go (TUG) test
* Age \> 50 years old
* Ability to give their written informed consent to participating in the study after having fully understood the contents of the study
* American Society of Anesthesiologists (ASA) physical status 1, 2, or 3

Exclusion Criteria

* Patients who cannot cooperate
* Patients who cannot understand or speak Danish.
* Patients with allergy or intolerance to the medicines used in the study
* Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl)
* Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment
* BMI \> 40
* Diagnosed with chronic central or peripheral neurodegenerative disorders

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No