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Completed

NCT Number: NCT03680716

Combined Saphenous Nerve and IPACK Blocks Versus Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction

A lot of patient have posterior knee pain after ACL reconstruction despite saphenous nerve block. Recently a new block has been described, know as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee). The objective of this randomized controlled double-blinded trial is to assess whether a combined saphenous nerve block with IPACK block is more effective for the postoperative pain than a local infiltration analgesia.

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Key information

Conditions

Postoperative Pain Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Rupture Knee Injuries Leg Injuries Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

The saphenous nerve and the iPACK will be performed after general anaesthesia induction and before the surgery under ultrasound-guidance.

The local infiltration analgesia will be performed by the surgeon during the surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Statut ASA I-III.
  • Patient scheduled for anterior crutiate ligament reconstruction under general anesthesia.

Exclusion criteria

  • Pregnancy.
  • Contraindication to local anesthesia.
  • Patient with chronic pain, opioid consumption or alcohol consumption.
  • Patient with coagulation trouble, hepatic dysfunction or renal dysfunction.
  • Patient with diabetic or femoral neuropathy.

Treatment and study plan

Ropivacaine injection

Drug

Saphenous nerve block with 20ml of ropivacaine 0.5% and IPACK block with 30ml of ropivacaine 0.2% (total dose of 160 mg).

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

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

    0= no pain, 10=the worst pain imaginable

  3. Rate of postoperative nausea and vomiting

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

    Yes/No

  4. Rate of antiemetic consumption

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

    Yes/No

  5. Rate of pruritus

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

    Yes/No

  6. Active flexion

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

    Flexion of the knee by the patient measured in degrees

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

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

    1=no contraction, 5=normal strength

  8. Distance walked (meters)

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

  9. Anterior Cruciate Ligament - Return to Sport after Injury survey

    Time frame: 4 and 8 postoperative months

  10. International Knee Documentation Committee score

    Time frame: 4 and 8 postoperative months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

Analgesic Efficacy of a Combined Saphenous Nerve Block and IPACK Block Versus Local Infiltration Analgesia After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Double-blinded Trial.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2018
Registry last updated
Jan 27, 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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