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

NCT04854395 | Completed Phase 4 DMC

• 2 other identifiers: Protocol_PPB_TKA_160320212021-000242-17
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Opioid Use; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Total opioid consumption in each group, A, B and C

  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

  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

  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

  A 60 minutes interval is between pre-block and post-block MVIC assessments

• Muscle strength of knee extension, graded by Manual Muscle Test (MMT)

  Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours after time of skin closure (end of surgery)

Study Arms (3)

Group A: Active FTB + Active PPB + Sham ACB

ACTIVE COMPARATOR

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

Group B: Active FTB + Sham PPB + Sham ACB

ACTIVE COMPARATOR

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

Group C: Sham FTB + Sham PPB + Active ACB

ACTIVE COMPARATOR

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

Drug: Marcain 5 mg/ml

Interventions

Marcain 5 mg/ml 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 A: Active FTB + Active PPB + Sham ACB; Group B: Active FTB + Sham PPB + Sham ACB; Group C: Sham FTB + Sham PPB + Active ACB

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regionshospitalet Silkeborg: lead

Study Sites (1)

Johan Kløvgaard Sørensen

Skanderborg, 8660, Denmark

Location

MeSH Terms

Conditions

Acute Pain; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Charlotte Runge, PhD

  Region Hospital Silkeborg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar

Model Details: 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)

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 22, 2021
• Study Start: April 9, 2021
• Primary Completion: June 26, 2023
• Study Completion: June 26, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At the end of study analysis
• Access Criteria: Permission by investigators

Locations

DK (1)