Femoral Triangle Block With Popliteal Plexus Block Versus Femoral Triangle Block Versus Adductor Canal Block for TKA
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Analgesia
- Opioid Use
- Pain Acute
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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)Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Both males and females
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 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.
Tracking Information
- NCT #
- NCT04854395
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Charlotte Runge, PhD Region Hospital Silkeborg
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