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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Pain, Acute; Opioid Use
• Intervention / Treatment: Drug: Marcain 5 mg/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.

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Johan K Sørensen, MD; Phone Number: 004528945356; Email: joksoe@rm.dk
• Study Contact Backup: Name: Charlotte Runge, PhD; Email: charlotte.runge@aarhus.rm.dk

Study Locations

• Denmark
  • Skanderborg, Denmark, 8660
    • Johan Kløvgaard Sørensen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: 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.
Active Comparator: 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	Drug: 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.
Active Comparator: Group C: Sham FTB + Sham PPB + Active ACB; Single shot bolus of 25 ml Marcain 5 mg/ml is used for ACB	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption in each group, A, B and C	Total opioid consumption is the aggregate of the opioid administered by the Patient Controlled Analgesia (PCA) pump and any potential rescue opioids administered, calculated as IV morphine equivalents	from time of skin closure (end of surgery) until 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption in each group, A, B and C	Total opioid consumption is the aggregate of the opioid administered by the PCA pump and any potential rescue opioids administered, calculated as IV morphine equivalents	from time of skin closure (end of surgery) until 12 hours postoperative
Post-block Maximum Voluntary Isometric Contraction (MVIC) by knee extension, calculated as a percentage of the Pre-block baseline value	Both MVIC test are assessed preoperative, using a handheld dynamometer	A 60 minutes interval is between pre-block and post-block MVIC assessments
Post-block MVIC by ankle plantarflexion, calculated as a percentage of the Pre-block baseline value	Both MVIC test are assessed preoperative, using a handheld dynamometer	A 60 minutes interval is between pre-block and post-block MVIC assessments
Post-block MVIC by ankle dorsiflexion, calculated as a percentage of the Pre-block baseline value	Both MVIC test are assessed preoperative, using a handheld dynamometer	A 60 minutes interval is between pre-block and post-block MVIC assessments
Muscle strength of knee extension, graded by Manual Muscle Test (MMT)	Grade 3: Able to extend the knee in active Range of Motion (ROM) against gravity, Grade 2: Patient is lying on the side, with knee resting on the bed, able to extend the knee in active ROM with minimal assistance from the investigator, Grade 1: Muscle contraction of the quadriceps muscle is palpable or observable but the knee does not extend, Grade 0: No muscle contraction of the quadriceps muscle is palpable or observable	Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours after time of skin closure (end of surgery)
Muscle strength of ankle plantarflexion, graded by MMT	Grade 3: Able to plantarflex in active ROM, Grade 2: Patient is lying on the side, with ankle resting on the bed, able to plantarflex the ankle in active ROM with minimal assistance from the investigator, Grade 1: Muscle contraction of the gastrocnemius muscle is palpable or observable but the ankle does not plantarflex, Grade 0: No muscle contraction of the gastrocnemius muscle is palpable or observable	Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours after time of skin closure (end of surgery)
Muscle strength of ankle dorsiflexion, graded by MMT	Grade 3: Able to dorsiflex in active ROM Grade 2: Patient is lying on the side, with ankle resting on the bed, able to dorsiflex the ankle in active ROM with minimal assistance from the investigator, Grade 1: Muscle contraction of the tibialis anterior muscle is palpable or observable but the ankle does not dorsiflex, Grade 0: No muscle contraction of the tibialis anterior muscle is palpable or observable	Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours after time of skin closure (end of surgery)
Timed Up and Go (TUG) test postoperative	Measure of seconds it takes a patient to get up from a chair with armrest, walk a distance of three meters, turn around, walk back and sit down again. All patients must use crutches for the test. If patient cannot mobilize with crutches, the test will not be performed.	Assessed 5 hours after time of skin closure (end of surgery)
Worst pain during TUG	Patient will be asked to indicate worst pain, Numeric Rating Scale (NRS), 0-10, experienced during the TUG test	Assessed at the end og the TUG test, 5 hours after time of skin closure (end of surgery)
Pain at rest	Patient will be asked to indicate pain intensity at rest (NRS, 0-10)	preoperative (preblock baseline), 2, 5 (prior to TUG test), 7, 20 and 24 hours after time of skin closure (end of surgery)
Pain during 90 degrees active flexion of the knee	Patient will be asked to indicate worst pain intensity during active flexion of the knee towards 90 degrees (NRS, 0-10)	preoperative (preblock baseline), 2, 5 (prior to TUG test), 7, 20 and 24 hours after time of skin closure (end of surgery)

Collaborators and Investigators

• Sponsor: Regionshospitalet Silkeborg
• Investigators: Principal Investigator: Charlotte Runge, PhD, Region Hospital Silkeborg

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2021
• Primary Completion (Actual): June 26, 2023
• Study Completion (Actual): June 26, 2023

Study Registration Dates

• First Submitted: April 18, 2021
• First Submitted That Met QC Criteria: April 18, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: Protocol_PPB_TKA_16032021; 2021-000242-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared after acceptance from the The Danish Data Protection Agency
• IPD Sharing Time Frame: At the end of study analysis
• IPD Sharing Access Criteria: Permission by investigators
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No