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The Effect of Distal Versus Proximal iPACK on Pain After Total Knee Arthroplasty

ConditionPostoperative Pain Following Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorComenius University

About this trial

Total knee arthroplasty (TKA) often results in significant postoperative pain, which can hinder recovery despite advances in surgical and anesthetic techniques. Traditional pain management methods like femoral nerve blocks may impair motor function, delaying rehabilitation. The iPACK block, targeting the posterior knee without affecting motor control, offers a promising alternative. This study aims to compare the effectiveness of two iPACK block approaches-proximal (at the distal femoral shaft) and distal (between the femoral condyles)-in managing postoperative pain in TKA patients. In a double-blind, randomized controlled trial with 120 participants, pain scores, opioid use, and time to rescue analgesia will be assessed. The hypothesis is that the distal iPACK block provides superior pain relief, potentially improving patient outcomes and recovery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 80 years

Patients undergoing primary unilateral total knee arthroplasty (TKA) for osteoarthritis

Ability to understand and sign informed consent

American Society of Anesthesiologists (ASA) classification I-III

Disqualifiers

Refusal to participate or failure to sign informed consent

Bilateral or revision TKA

Partial or unicondylar knee replacement

Severe knee deformity (flexion, varus, or valgus >30°)

Trial design

Design model

Parallel

Treatments tested in this trial

  • distal iPACK

    Procedure/Surgery

    ● In the distal iPACK group, participants will receive 20 ml of 0.25% levobupivacaine with adrenaline (1:200,000), injected at the most distal part of the thigh, between the femoral condyles.

  • proximal iPACK

    Procedure/Surgery

    ● In the proximal iPACK group, participants will receive 20 ml of 0.25% levobupivacaine with adrenaline (1:200,000), injected at the level of the distal femoral shaft (a straight portion of the femur without the condyles).

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: proximal iPACK groupExperimental treatment 1 intervention
Group B: distal iPACK groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

total opioids consumption

total opioids consumption calculated to MME (morphine milligrams equivalent)

Time frame
from surgery until 24 hours after surgery

Secondary outcomes

1

time to first opioid administration

time to first opioid administration time in hours to first opioid administration after operation.

Time frame
up to 24 hours after surgery
2

Visual analog scale 6 (rest)

pain intensity will be measured using the Visual Analogue Scale at rest 6 hours postoperatively. The Visual Analogue Scale is a validated, 100-mm horizontal line used to measure pain intensity, ranging from "no pain" (0 mm) to "worst possible pain" (100 mm).

Time frame
6 hours postoperatively
3

Visual analog scale 12 (rest)

pain intensity will be measured using the Visual Analogue Scale at rest 12 hours postoperatively. The Visual Analogue Scale is a validated, 100-mm horizontal line used to measure pain intensity, ranging from "no pain" (0 mm) to "worst possible pain" (100 mm).

Time frame
12 hours postoperatively
4

Visual analog scale 24 (rest)

pain intensity will be measured using the Visual Analogue Scale at rest 24 hours postoperatively, The Visual Analogue Scale is a validated, 100-mm horizontal line used to measure pain intensity, ranging from "no pain" (0 mm) to "worst possible pain" (100 mm).

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

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

Comenius University

Lead sponsor

Source ClinicalTrials.gov
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