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Completed

NCT Number: NCT01212666

The Efficacy of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction

The Purpose of this study is to determine whether Adductor-Canal-Block is superior to placebo when it comes to analgetic efficacy after reconstruction of the anterior cruciate ligament.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anaesthesiology, Glostrup University Hospital

Copenhagen, Glostrup, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-70 years
  • Reconstruction of Anterior Cruciate Ligament
  • Written consent
  • ASA I-II
  • BMI 19-35

Exclusion criteria

  • Unable to communicate in Danish
  • Allergic reactions toward drugs used in the trial
  • Pregnancy
  • Abuse of alcohol/drugs
  • Daily opioid intake
  • Infection at injection site
  • Can not be mobilised to 5 meters of walk; pre-surgery

Treatment and study plan

Ropivacain

Procedure

Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.

Other names: Naropin

Saline

Procedure

Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.

Primary outcomes

  1. Pain-score (VAS), patient standing

    Time frame: 2 hours postoperative

    Pain-score messured on a Visual Analog Scale (VAS) 2 hours after adductor canal block. Patient standing. Intervention-group vs. placebo-group.

Secondary outcomes

  1. Total Opioid-consumption

    Time frame: 0-24 hours postoperative

    ACB-group vs. placebo-group

  2. Postoperative Nausea and Vomiting

    Time frame: 0 hour postoperative

    Levels of nausea (0-3). ACB-group vs. placebo-group

  3. Postoperative ondansetron consumption

    Time frame: In hospital

  4. Pain-score (VAS), patient at rest

    Time frame: 0 hours postoperative

    ACB-group vs. placebo

  5. Pain-score (VAS), patient at rest

    Time frame: 1 hour postoperative

    ACB-group vs. placebo

  6. Pain-score (VAS), patient at rest

    Time frame: 2 hours postoperative

    ACB-group vs. placebo

  7. Pain-score (VAS), patient at rest

    Time frame: 4 hours postoperative

    ACB-group vs. placebo

  8. Pain-score (VAS), patient at rest

    Time frame: 6 hours postoperative

    ACB-group vs. placebo

  9. Pain-score (VAS), patient at rest

    Time frame: 8 hours postoperative

    ACB-group vs. placebo

  10. Pain-score (VAS), patient at rest

    Time frame: 24 hours postoperative

    ACB-group vs. placebo

  11. Pain-score (VAS), patient standing

    Time frame: 1 hour postoperative

    ACB-group vs. placebo

  12. Pain-score (VAS), patient standing

    Time frame: 2 hours postoperative

    ACB-group vs. placebo

  13. Pain-score (VAS), patient standing

    Time frame: 4 hours postoperative

    ACB-group vs. placebo

  14. Pain-score (VAS), patient standing

    Time frame: 6 hours postoperative

    ACB-group vs. placebo

  15. Pain-score (VAS), patient standing

    Time frame: 8 hours postoperative

    ACB-group vs. placebo

  16. Pain-score (VAS), patient standing

    Time frame: 24 hours postoperative

    ACB-group vs. placebo

  17. Pain-score (VAS), after 5 meters of walk

    Time frame: 2 hours postoperative

    ACB-group vs. placebo

  18. Pain-score (VAS), after 5 meters of walk

    Time frame: 4 hours postoperative

    ACB-group vs. placebo

  19. Pain-score (VAS), after 5 meters of walk

    Time frame: 6 hours postoperative

    ACB-group vs. placebo

  20. Pain-score (VAS), after 5 meters of walk

    Time frame: 8 hours postoperative

    ACB-group vs. placebo

  21. Pain-score (VAS), after 5 meters of walk

    Time frame: 24 hours postoperative

    ACB-group vs. placebo

  22. Postoperative Nausea and Vomiting

    Time frame: 1 hours postoperative

    Levels of nausea (0-3). ACB-group vs. placebo-group

  23. Postoperative Nausea and Vomiting

    Time frame: 2 hours postoperative

    Levels of nausea (0-3). ACB-group vs. placebo-group

  24. Postoperative Nausea and Vomiting

    Time frame: 4 hours postoperative

    Levels of nausea (0-3). ACB-group vs. placebo-group

  25. Postoperative Nausea and Vomiting

    Time frame: 6 hours postoperative

    Levels of nausea (0-3). ACB-group vs. placebo-group

  26. Postoperative Nausea and Vomiting

    Time frame: 8 hours postoperative

    Levels of nausea (0-3). ACB-group vs. placebo-group

  27. Postoperative Nausea and Vomiting

    Time frame: 24 hours postoperative

    Levels of nausea (0-3). ACB-group vs. placebo-group

  28. Sedation

    Time frame: 0, hour postoperative

    Levels of sedation (0-3). ACB-group vs. placebo

  29. Sedation

    Time frame: 1 hour postoperative

    Levels of sedation (0-3). ACB-group vs. placebo

  30. Sedation

    Time frame: 2 hours postoperative

    Levels of sedation (0-3). ACB-group vs. placebo

  31. Sedation

    Time frame: 4 hours postoperative

    Levels of sedation (0-3). ACB-group vs. placebo

  32. Sedation

    Time frame: 6 hours postoperative

    Levels of sedation (0-3). ACB-group vs. placebo

  33. Sedation

    Time frame: 8 hours postoperative

    Levels of sedation (0-3). ACB-group vs. placebo

  34. Sedation

    Time frame: 24 hours postoperative

    Levels of sedation (0-3). ACB-group vs. placebo

  35. Postoperative Nausea and Vomiting

    Time frame: 0 hours postoperative

    Levels of nausea (0-3). ACB-group vs. placebo-group

  36. Pain (VAS) at rest, 0-24 hours postoperative (AUC)

    Time frame: 0-24 h postoperative

    Pain-score messured on a Visual Analog Scale (VAS) 0-24 hours after adductor canal block (AUC). Patient at rest. Intervention-group vs. placebo-group.

  37. Pain (VAS), patient standing, 1-24 hours postoperative (AUC)

    Time frame: 1-24 hours postoperative

    Pain-score messured on a Visual Analog Scale (VAS) 1-24 hours after adductor canal block (AUC). Patient standing. Intervention-group vs. placebo-group.

  38. Pain (VAS), pain after 5 meters of walk, 2-24 hours postoperative (AUC)

    Time frame: 2-24 hours postoperative

    Pain-score messured on a Visual Analog Scale (VAS) 2-24 hours after adductor canal block (AUC). Pain after 5 meters of walk. Intervention-group vs. placebo-group.

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

The Effect of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction in Day Case Surgery

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 1, 2010
Registry last updated
Sep 11, 2012

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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