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Completed

NCT Number: NCT04499716

Quadriblock Versus "IPACK + Femoral Triangle Block + Obturator Nerve Block" in Total Knee Arthroplasty

Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.

Postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). For optimal pain management, several peripheral nerve blocks should be associated. Thus, a recent study shows that the combination of IPACK, femoral triangle and obturator nerve blocks (ITO blocks) provides an effective pain control after TKA.

The hypothesis of this study is that a quadruple nerve block combining femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks (quadri-block) could improve analgesia after TKA.

The main objective of this monocenter, prospective, randomized, open-label, controlled trial is to assess the effect of quadri-block on morphine consumption after TKA compared to ITO blocks.

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Key information

Conditions

Primary Total Knee Arthroplasty Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Médipôle Garonne

Toulouse, Haute-Garonne, 31036, France

About this study

In the pre-anaesthesia room, after the implementation of classical monitoring with an oxygen mask and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to SFAR (French Society of Anesthesia & Intensive Care Medecine) recommendations and injection of 10 mg of IV dexamethasone.

The patients will be then randomized in 2 groups:

  • ITO group (usual technique): IPACK combined to femoral triangle and obturator nerve blocks
  • Quadriblock group (experimental technique): femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks.

An experienced anesthetist will perform ultrasound-guided blocks 30 minutes before surgery with ropivacaine 0.3%, total volume of 70 ml.

In the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg) and propofol (3 mg/kg). Anesthesia will be maintained with propofol.

Postoperative analgesia protocol :

  • Multimodal analgesia will be instituted from the end of the surgery by the administration of paracetamol (1 g) and ketoprofen (100 mg).
  • In post-anesthesia care unit (PACU): oxynorm titration if VRS (pain score) >3 according to the centre's usual care.
  • In ward: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day); oxynorm (10 mg, lockout interval: 4 h) if VRS (pain score) >3.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years and older,
  • Primary total knee arthroplasty
  • Consent for participation,
  • Affiliation to a social security system

Exclusion criteria

  • Preoperative morphine use
  • Chronic pain syndrome
  • Contraindication to any drugs used in the protocol (paracetamol, ketoprofen, oxynorm, propofol, ketamine, ropivacaine)
  • Valgus > 9°
  • Pregnant or breastfeeding women
  • Patients under protection of the adults (guardianship, curators or safeguard of justice)

Treatment and study plan

IPACK

Procedure

25 milliliters of ropivacaine 0.3% will be injected between popliteal artery and femur.

Femoral Triangle Block

Procedure

25 milliliters of ropivacaine 0.3% will be injected on the lateral side of the femoral artery at the distal part of the femoral triangle.

Obturator nerve block

Procedure

20 milliliters of ropivacaine 0.3% will be injected between the adductor magnus and adductor brevis muscles and between the adductor brevis muscle the pectineus.

Femoral Nerve Block

Procedure

20 milliliters of ropivacaine 0.3% will be injected in supine position under the fascia iliaca lateral to the femoral artery.

Sciatic Nerve Block

Procedure

25 milliliters of ropivacaine 0.3% will be injected in prone position in the subgluteal space by lateral approach.

Lateral femoral cutaneous nerve block

Procedure

5 milliliters of ropivacaine 0.3% will be injected laterally to the sartorius muscle.

Primary outcomes

  1. Postoperative analgesia, defined by the morphine consumption in the first 48 hours post-surgery.

    Time frame: 48 hours

    Total amount of oxynorm (mg) administered during the first 48 hours post-surgery.

Secondary outcomes

  1. Postoperative pain: Verbal Rating Scale (VRS)

    Time frame: 48 hours

    Pain will be assessed every 6 hours using a Verbal Rating Scale (VRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain).

  2. Oxynorm consumption in the first 24 hours post-surgery

    Time frame: 24 hours

    Total amount of oxynorm (mg) administered during the first 24 hours post-surgery.

  3. Ability to walk

    Time frame: 48 hours

    0: unable to get up; 1: able to get up but not to walk; 2: walk <50 m; 3: walk > 50 m

  4. Quadricep mobilization

    Time frame: 48 hours

    0: paralysis; 1: paresis, 2: normal contraction

  5. Foot elevator muscle mobilization

    Time frame: 48 hours

    0: paralysis; 1: paresis; 2: normal contraction

  6. Side effects of opioids

    Time frame: 48 hours

    Collect side effects associated with oxynorm : nausea or vomiting, drowsiness, constipation, urinary retention, itching, disorientation.

Sponsors and collaborators

Lead sponsor

Clinique Medipole Garonne

Other

Registry information

Official study title

Quadriblock Versus "IPACK + Femoral Triangle Block + Obturator Nerve Block" in Total Knee Arthroplasty: a Randomized Controlled Clinical Trial

Acronym: QuITO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2020
Registry last updated
Jun 7, 2021

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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