BLOCK-study: Better Local Orthopedic Pain Control After Knee Arthroplasty

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

RECRUITING

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-09

Study Completion Date

2027-11-30

Brief Summary

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The goal of this study is to compare the anesthetic combination iPACK with femoral triangle block versus surgical LIA for unilateral TKA. We hypothesize that an iPACK block with femoral triangle block is non-inferior to surgical LIA. Furthermore, due to visualization of the relevant neural and vascular structures, the risk of accidental popliteal block, nerve damage or LAST with (a blindly performed) LIA could theoretically be reduced.

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Detailed Description

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Conditions

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Knee Arthroplasty, Total

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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iPACK with Femoral Triangle Block (FTB)

Patients undergoing an unillateral total kneearthroplasty will receive the anesthetic combination iPACK with FTB.

Group Type ACTIVE_COMPARATOR

Locoregional anesthesia

Intervention Type PROCEDURE

The FTB + iPACK group will receive 12 ml 0,5% ropivacaine for the FTB and 20 ml of ropivacaine 0.5% for the iPACK block under US guidance after spinal anesthesia

Surgical Local Infiltration Analgesia (LIA)

Patients undergoing an unillateral total kneearthroplasty will receive the surgical LIA.

Group Type ACTIVE_COMPARATOR

Local Anesthetic Ropivacaine

Intervention Type PROCEDURE

The control group (LIA) will receive 120 ml 0.25% ropivacaine for surgical LIA placement.

Interventions

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Locoregional anesthesia

The FTB + iPACK group will receive 12 ml 0,5% ropivacaine for the FTB and 20 ml of ropivacaine 0.5% for the iPACK block under US guidance after spinal anesthesia

Intervention Type PROCEDURE

Local Anesthetic Ropivacaine

The control group (LIA) will receive 120 ml 0.25% ropivacaine for surgical LIA placement.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA I-III
* BMI 17-35 kg/m2
* Patient is able to give informed consent
* Patient is scheduled for TKA

Exclusion Criteria

* Refusal of patient
* Inability to communicate due to language or neurologic barriers
* Bilateral TKA or unilateral knee arthroplasty
* Chronic opioid use (including partial opioid agonists) + chronic pain patients:
* Use of atypical analgesics (gabapentin, pregabalin, …)
* History of Sudeck atrophy
* History of \>3 chronic pain consultations
* Contraindications for spinal anesthesia
* Patient refusal
* Local infection
* Aberrant coagulation (according to the latest ESRA guidelines)
* Severe spinal canal stenosis
* Intracranial hypertension
* History of neurological injury in the affected limb
* Contraindications for local anesthetics
* Allergy for local anesthetics
* Absolute contraindications for NSAIDs or paracetamol
* Proven allergy for NSAID's (including ASA syndrome) or paracetamol
* Severe renal function impairment (eGFR \<30 ml/min/1.73 m2)
* Active or recent (\<6 months) history of gastric ulcera/perforations/bleeding
* Crohn disease or colitis ulcerosa
* Liver function impairment or severe renal function impairment (eGFR \<30 ml/min/1.73 m2)
* Pregnancy or breast-feeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No