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Completed

NCT Number: NCT02524652

Local Infiltration Analgesia vs Adductor Canal Block for Analgesia After Anterior Cruciate Ligament Reconstruction

Early rehabilitation after anterior cruciate ligament reconstruction is of paramount importance and requires optimal pain control based on a multimodal concept, including injection of local anaesthetics. Regarding this latter, different options have emerged recently such as the adductor canal block, performed before the surgery by the anaesthesiologist or the infiltration of the articulation performed by the surgeon at the of the intervention. No trial has compared these two approaches. As practice of medicine should be based on evidence, we decided to undertake this randomised controlled trial where we compared the adductor canal block with the local infiltration analgesia technique in terms of pain and functional outcomes

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Key information

Conditions

Rupture of Anterior Cruciate Ligament Anterior Cruciate Ligament Injuries Infiltration Knee Injuries Leg Injuries Regional Anesthesia Morbidity Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

Patients scheduled to undergo anterior cruciate ligament reconstruction under general anaesthesia will be randomly allocated to two groups: local infiltration analgesia or adductor canal block.

The local infiltration analgesia will be performed by the surgeon at the end of surgery with 20 mLs of ropivacaine 0.5%. The adductor canal block will be performed by the anaesthesiologist under ultrasound guidance after the surgery, before awaking the patient, using the same solution (20 mLs ropivacaine 0.5%)

Postoperative analgesia will include intravenous patient-controlled analgesia of morphine (settings 1 mg/ml, 2 ml/10 minutes, 40 mg/4 hours), ibuprofen (3x400 mg) and acetaminophen (4x1000 mg).

A research assistant and a physiotherapist, both blinded to the group allocation, will collect pain and rehabilitation data, respectively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction

Exclusion criteria

  • peripheral neuropathy
  • pre-existing femoral neuropathy
  • diabetes mellitus
  • alcoholism
  • drug addiction
  • cancer with chemotherapy
  • chronic pain state

Treatment and study plan

Ropivacaine 0.5% 20 mLs

Drug

Injection of the local anesthetic at the end of surgery, either in the surgical sites by the surgeon, or in the adductor canal block by the anesthesiologist under ultrasound guidance.

Other names: Naropine, Naropin

Primary outcomes

  1. Total morphine consumption (mg)

    Time frame: 24 h postoperatively

Secondary outcomes

  1. Total morphine consumption (mg)

    Time frame: 2 h postoperatively

  2. Total morphine consumption (mg)

    Time frame: 48 h postoperatively

  3. Total morphine consumption (mg)

    Time frame: 72 h postoperatively

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

    Time frame: 2 h postoperatively

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

    Time frame: 12 h postoperatively

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

    Time frame: 24 h postoperatively

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

    Time frame: 36 h postoperatively

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

    Time frame: 48 h postoperatively

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

    Time frame: 60 h postoperatively

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

    Time frame: 72 h postoperatively

  11. Postoperative nausea and vomiting (yes/no)

    Time frame: 24 h postoperatively

  12. Postoperative nausea and vomiting (yes/no)

    Time frame: 48 h postoperatively

  13. Postoperative nausea and vomiting (yes/no)

    Time frame: 72 h postoperatively

  14. Pruritus (yes/no)

    Time frame: 24 h postoperatively

  15. Pruritus (yes/no)

    Time frame: 48 h postoperatively

  16. Pruritus (yes/no)

    Time frame: 72 h postoperatively

  17. Active flexion

    Time frame: 24 h postoperatively

    Flexion of the knee by the patient measured in degrees

  18. Active flexion

    Time frame: 48 h postoperatively

    Flexion of the knee by the patient measured in degrees

  19. Active flexion

    Time frame: 72 h postoperatively

    Flexion of the knee by the patient measured in degrees

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

    Time frame: 24 h postoperatively

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

    Time frame: 48 h postoperatively

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

    Time frame: 72 h postoperatively

  23. Distance walked (meters)

    Time frame: 24 h postoperatively

  24. Distance walked (meters)

    Time frame: 48 h postoperatively

  25. Distance walked (meters)

    Time frame: 72 h postoperatively

  26. Anterior Cruciate Ligament - Return to Sport after Injury scale

    Time frame: 4 months postoperatively

  27. Anterior cruciate ligament -Return to Sport after Injury scale

    Time frame: 8 months postoperatively

  28. International Knee Documentation Committee score

    Time frame: 4 months postoperatively

  29. International Knee Documentation Committee score

    Time frame: 8 months postoperatively

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

Postoperative Analgesic Efficacy of Local Infiltration Analgesia Versus Adductor Canal Block After Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Double-blinded Trial

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2015
Registry last updated
May 7, 2018

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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