Health TrialsbyHealthPanel

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

ConditionKnee Arthroplasty, Total
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorJessa Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA I-III

BMI 17-35 kg/m2

Patient is able to give informed consent

Patient is scheduled for TKA

Disqualifiers

Refusal of patient

Inability to communicate due to language or neurologic barriers

Bilateral TKA or unilateral knee arthroplasty

Use of atypical analgesics (gabapentin, pregabalin, …)

Trial design

Design model

Sequential

Treatments tested in this trial

  • Locoregional anesthesia

    Procedure/Surgery

    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

  • Local Anesthetic Ropivacaine

    Procedure/Surgery

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

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: iPACK with Femoral Triangle Block (FTB)Active comparator 1 intervention
Group B: Surgical Local Infiltration Analgesia (LIA)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Numerical Rating Scale (NRS) pain score at mobilization at 8 hour postoperatively

The NRS pain score will be determined immediately after mobilizing patients from the bed to their seat at 8 hour postoperatively

Time frame
8 hours postoperatively

Secondary outcomes

1

NRS pain at movement for the first 24 hours

The Area Under the Curve for the NRS pain scores at movement will be evaluated at 4h-6h-8h-12h-24h after the surgery

Time frame
24 hours postoperatively
2

NRS pain at rest for the first 24 hours

The Area Under the Curve for the NRS pain scores at rest will be evaluated at 4h-6h-8h-12h-24h after the surgery

Time frame
24 hours postoperatively
3

Rate of popliteal block 8 hours after surgery

the incidence of a popliteal block will be assessed 8 hours after surgery

Time frame
8 hours postoperatively
4

Functional recovery: timed up and go test

Patients have to sit in a standard sitting chair, stand up from the chair, walk 3 meters, get back to the chair and sit down. A cut-off of 13.5 seconds or longer indicates higher risk of falls, normal values depend on age.

Time frame
Baseline, 24 hours and 48 hours after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jessa Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now