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Completed

NCT Number: NCT03698006

Selective Tibial Nerve Block vs Local Infiltration Analgesia After Prothetic Knee Surgery

Patient suffer from moderate posterior knee pain after TKA despite injection of local anesthetic around the femoral or saphenous nerves. Indeed, the posterior part of the knee is innervated by the sciatic nerve. This nerve is not routinely blocked as clinicians fear to produce a motor block of the leg that might impair the postoperative assessment. An analgesic alternative is the infiltration of the knee with local anesthetics performed by the surgeon. Recently a trial(1) demonstrated that a selective tibial nerve block provides an effective analgesia without a motor blockage when compared with a sciatic nerve block. The objective of this randomized controlled double-blinded trial is to assess whether a tibial nerve block is more effective for the postoperative pain than local infiltration analgesia when there are combined with an adductor canal block, without decreasing the functional parameters.

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Key information

Conditions

Postoperative Pain Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eric Albrecht

Lausanne, English, 1004, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient scheduled for a total knee arthroplasty under spinal block.
  • Patient with a weight above 40kg.

Exclusion criteria

  • Patient with ASA IV status.
  • Contraindication to spinal block, or peripheral nerve blocks.
  • Neurological deficit of the lower limb.
  • Patient with renal dysfunction.
  • Patient with chronic pain, opioid consumption or alcohol consumption.
  • Pregnancy.

Treatment and study plan

Ropivacaine 0.5% Injectable Solution

Drug

Tibial nerve block with 10ml of Ropivacaine 0.5%

Ropivacaine 0.2% Injectable Solution

Drug

Infiltration with 25ml of Ropivacaine 0.2% in the posterior knee capsule

Primary outcomes

  1. Total morphine consumption (mg)

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. Total morphine consumption (mg)

    Time frame: 2 hours, 48 hours and 72 hours postoperatively

  2. Analgesic duration (minutes)

    Time frame: Postoperative day 0

    Time from the block to the first analgesic request

  3. Pain scores (numeric rating scale, 0-10) at rest and on movement

    Time frame: 2 hours, 24 hours, 48 hours and 72 hours postoperatively

    0= no pain, 10=the worst pain imaginable

  4. Rate of postoperative nausea and vomiting

    Time frame: 2 hours, 24 hours, 48 hours and 72 hours postoperatively

    Yes/No

  5. Rate of prurit

    Time frame: 2 hours, 24 hours, 48 hours and 72 hours postoperatively

    Yes/No

  6. Active flexion

    Time frame: 24hours, 48hours and 72hours postoperatively

    Flexion of the knee by the patient measured in degrees

  7. Passive flexion

    Time frame: 24hours, 48hours and 72hours postoperatively

    Flexion of the knee by physiotherapist measured in degrees

  8. Quadriceps muscle strength (numeric scale, 1-5)

    Time frame: 24hours, 48hours and 72hours postoperatively

    1=no contraction, 5=normal strength

  9. Distance walked (meters)

    Time frame: 24hours, 48hours and 72hours postoperatively

  10. Complication of tibial nerve block

    Time frame: up to 1 week

    Intravascular injection/hematoma/infection/Common peroneal nerve block

  11. Length of stay in hospital

    Time frame: up to 14 days

    Days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

Optimal Pain Control After Prothetic Knee Surgery Either by Selective Tibial Nerve Block Versus Local Infiltration Analgesia

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2018
Registry last updated
Oct 10, 2022

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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