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Recruiting NCT07130552

Comparison of Distal IPACK and Popliteal Plexus Block Combined With Femoral Triangle Block After Total Knee Arthroplasty

No phase Interventional Osteo Arthritis of the Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: femoral triangle block and popliteal plexus block, Femoral triangle block and distal iPACK.
Who it may be relevant to
Registry conditions: Osteo Arthritis of the Knee. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study aims to investigate the effect of femoral triangle block combined with popliteal plexus block and distal IPACK block on postoperative pain after total knee arthroplasty (TKA)

Detailed description

Popliteal Plexus Block (PPB) is a new nerve block technique that has been shown to anaesthetise nerves involved in the innervation of the posterior part of the knee joint.

The IPACK (interspace between the popliteal artery and capsule of the posterior knee) block is a regional anesthesia technique in which a local anesthetic is infiltrated under ultrasound guidance between the popliteal artery and the capsule of the posterior knee. This technique blocks the branches of the obturator nerve, the common peroneal nerve, and the tibial nerve in the popliteal region. In the context of knee arthroplasty, the application of the IPACK block has been associated with lower scores for ambulatory pain, lower scores for resting pain, and reduced morphine consumption.

Although both techniques of blockade seem to be efficient in the context of analgesia for the posterior part of the knee after TKA. No study compares these two blocks as part of multimodal analgesia to provide pain relief after TKA.

This study aimed to evaluate the analgesic effect of PPB or distal IPACK, in addition to femoral triangle block, as a component of a multimodal analgesic regimen after TKA.

Interventions

  • Device femoral triangle block and popliteal plexus block
    Single dose bolus, 10 ml 5% bupivacaine will be used for FTB, 10 ml 5% bupivacaine will be used for PPB
  • Device Femoral triangle block and distal iPACK
    Single dose bolus, 10 ml 5% bupivacaine will be used for FTB, 10 ml 5% bupivacaine will be used for distal iPACK

Primary outcome measures

  • Opioid consumption [Time frame: 24 hours]
Secondary outcome measures (11)
  • NRS scores [Time frame: 48 hours]
  • Range of knee motion [Time frame: 48 hours]
  • Patient mobilization [Time frame: 48 hours]
  • Post-block Maximum Voluntary Isometric Contraction (MVIC) by knee extension, calculated as a percentage of the Pre-block baseline value [Time frame: A 60-minute 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 [Time frame: A 60-minute 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 [Time frame: A 60 minutes interval is between pre-block and post-block MVIC assessments]
  • Muscle strength of knee extension, graded by Manual Muscle Test (MMT) [Time frame: Assessed pre-block, post-block (60 minutes after pre-block), and postoperative 5 hours]
  • Muscle strength of ankle plantarflexion, graded by MMT [Time frame: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours]
  • Muscle strength of ankle dorsiflexion, graded by MMT [Time frame: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours]
  • Incidence of rebound pain [Time frame: Postoperative 24 hours]
  • Quality of Recovery 15 Score [Time frame: Postoperative Day 1]

Eligibility criteria

Inclusion criteria

  • Patients undergoing total knee arthroplasty under spinal anesthesia
  • American Society of Anesthesiologists (ASA) status I-III
  • Patients who give informed consent

Exclusion criteria

  • Patients unable to cooperate
  • Kidney disease with GFR < 50 ml/min
  • Daily opioid consumption > 1 month
  • Allergy to local anesthetics
  • Neurological problems of the lower extremity
  • Contraindications to peripheral nerve blocks

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Karaman Training and Research Hospital, Karaman, Karaman 70200 — Karaman

Identifiers

NCT: NCT07130552 · 06-2022/16

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗