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NCT Number: NCT05390450

Ultrasound-Guided Popliteal Plexus Block Versus Fascia Iliaca Block After Total Knee Arthroplasty

This study aims to investigate the effect of the Popliteal Plexus Block versus Fascia Iliaca Block on postoperative pain after total knee arthroplasty.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, Elgharbia, 31527, Egypt

About this study

The Popliteal Plexus entwines the popliteal artery and vein contiguous to the adductor hiatus in the popliteal fossa and innervates the posterior capsule as well as intraarticular genicular structures. It was recently confirmed in a cadaver study that injection of 10 mL of dye into the distal end of the adductor canal spreads via the adductor hiatus to the popliteal fossa and stains the Popliteal Plexus.

Recently, fascia iliaca block was proposed as a popular analgesic technique which involves local infiltration anesthesia under the fascia of the iliacus muscle. The method depends on the local anesthetics spread beneath the fascia to block the peripheral nerve. It has been proposed to avoid the complications by anesthetizing the femoral nerve remotely from major neurovascular structures and achieve adequate analgesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 40 - 75 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) score I-II.
  • Scheduled for unilateral, primary TKA under spinal anesthesia.

Exclusion criteria

  • Coagulopathy.
  • Diabetes.
  • Obesity.
  • Heart failure.
  • kidney failure.
  • Liver failure.
  • Reduced sensation on the lower limb.
  • Daily intake of opioids.
  • Contraindication to any drug used in the study.

Treatment and study plan

Ultrasound-Guided Popliteal Plexus Block

Device

Patients in this group will receive Popliteal plexus block. Prior to Popliteal plexus block, the proximal end of the adductor canal will be identified. The transducer will be slid distally along the femoral artery until the artery deviated away from the sartorius muscle in the distal part of the adductor canal towards the adductor hiatus. The nerve block needle will be inserted from the anterolateral end of the transducer and advanced in-plane through the medial vastus muscle. The endpoint of injection will be inside the distal end of the adductor canal close to the adductor hiatus. The injection will be adjacent to the femoral artery, between the medial vastus muscle and the adductor magnus muscle. The Popliteal plexus block will be carried out with 10 mL of local anesthetic mixture, containing 50 mg of bupivacaine and 0.05 mg of epinephrine.

Ultrasound-Guided Fascia Iliaca block

Device

Patients will be placed in a supine position, and the skin will be cleaned aseptically. The inguinal ligament from the anterior superior iliac spine to the pubic tubercle will be drawn on the skin and divided into 3 parts. The injection point was 1 cm caudally from the point where the lateral and middle part of the inguinal ligament met. The skin and deep tissues were infiltrated with 1% lidocaine. A 18G nerve block needle will be inserted into the skin perpendicularly until the first (fascia lata) and second loss of resistance (fascia iliaca) will be felt. Following aspiration to exclude intravascular injection, 40 mL of 0.25% bupivacaine (1-1.5 mg/kg), which will be prepared under aseptic conditions, and then injected. Sensorial block will be evaluated using the pinprick test 20 minutes after injection for areas of the thigh innervated by the femoral, lateral cutaneous and obturator nerves.

Primary outcomes

  1. Total intravenous (IV) morphine consumption

    Time frame: 24 hours postoperatively.

    Total intravenous (IV) morphine consumption during the first postoperative 24 hours, postoperatively.

Secondary outcomes

  1. First analgesic request

    Time frame: 24 hours postoperatively

    Time to first analgesic request after surgery in the form of intravenous morphine in a dose (0.05 mg/kg).

  2. Pain level score

    Time frame: 24 hours postoperatively

    Pain levels using the numerical rating scale (NRS) of pain intensity (0 = no pain) to (10 = intolerable pain), pain relief is defined as a NRS of 3 or lower. If the score is >3, the patient will need analgesia in the form of morphine 0.05 mg/kg till it decreases to ≤3. NRS will be assessed and recorded on arrival to Post-Anesthesia Care Unit , 1, 2, 4, 8, 12 and 24 hours postoperatively at rest and on movement (knee flexion) during the first postoperative 24 hours.

  3. Rehabilitation

    Time frame: 24 hours postoperatively

    Rehabilitation (time to ability to sit, time to ability to stand, time to ability to walk, Time to ability to do exercise) will be recorded.

  4. Patient's satisfaction level

    Time frame: 24 hours postoperatively

    Degree of patient satisfaction will be assessed on a 5-point scale; (1= highly satisfied, 2 = satisfied, 3 = neither satisfied nor unsatisfied, 4 = not satisfied, 5 = highly not satisfied)

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Ultrasound-Guided Popliteal Plexus Block Versus Fascia Iliaca Block for Postoperative Analgesia After Total Knee Arthroplasty: A Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 25, 2022
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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