Clinical trial NCT04854395: Femoral Triangle Block With Popliteal Plexus Block Versus Femoral Triangle Block Versus Adductor Canal Block for TKA
Official title: The Effect of the Popliteal Plexus Block on Postoperative Opioid Consumption, Pain, Muscle Strength and Mobilization After Total Knee Arthroplasty - a Randomized, Controlled, Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Acute
Opioid Use
Analgesia
Lead sponsor: Regionshospitalet Silkeborg
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 165
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total opioid consumption in each group, A, B and C
timeFrame: from time of skin closure (end of surgery) until 24 hours postoperative
Secondary outcomes:
measure: Total opioid consumption in each group, A, B and C
timeFrame: from time of skin closure (end of surgery) until 12 hours postoperative
measure: Post-block Maximum Voluntary Isometric Contraction (MVIC) by knee extension, calculated as a percentage of the Pre-block baseline value
timeFrame: A 60 minutes interval is between pre-block and post-block MVIC assessments
measure: Post-block MVIC by ankle plantarflexion, calculated as a percentage of the Pre-block baseline value
timeFrame: A 60 minutes interval is between pre-block and post-block MVIC assessments
measure: Post-block MVIC by ankle dorsiflexion, calculated as a percentage of the Pre-block baseline value
timeFrame: A 60 minutes interval is between pre-block and post-block MVIC assessments
measure: Muscle strength of knee extension, graded by Manual Muscle Test (MMT)
timeFrame: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours after time of skin closure (end of surgery)
measure: Muscle strength of ankle plantarflexion, graded by MMT
timeFrame: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours after time of skin closure (end of surgery)
measure: Muscle strength of ankle dorsiflexion, graded by MMT
timeFrame: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours after time of skin closure (end of surgery)
measure: Timed Up and Go (TUG) test postoperative
timeFrame: Assessed 5 hours after time of skin closure (end of surgery)
measure: Worst pain during TUG
timeFrame: Assessed at the end og the TUG test, 5 hours after time of skin closure (end of surgery)
measure: Pain at rest
timeFrame: preoperative (preblock baseline), 2, 5 (prior to TUG test), 7, 20 and 24 hours after time of skin closure (end of surgery)
measure: Pain during 90 degrees active flexion of the knee
timeFrame: preoperative (preblock baseline), 2, 5 (prior to TUG test), 7, 20 and 24 hours after time of skin closure (end of surgery)
Other outcomes:
Locations:
city: Skanderborg
country: Denmark
facility: Johan Kløvgaard Sørensen
Study officials:
affiliation: Region Hospital Silkeborg
name: Charlotte Runge, PhD
role: PRINCIPAL_INVESTIGATOR
References: