ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01212666
Recruitment Status : Completed
First Posted : October 1, 2010
Last Update Posted : September 11, 2012
Sponsor:
Information provided by (Responsible Party):
Malene Espelund, Glostrup University Hospital, Copenhagen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Procedure: Ropivacain Procedure: Saline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction in Day Case Surgery
Study Start Date : May 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adductor-Canal-Block, Ropivacain
25 patients. ACB. 30 mL Ropivacain 7,5 mg/mL. Ultrasound-guided application.
Procedure: Ropivacain
Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.
Other Name: Naropin

Placebo Comparator: Adductor Canal Block, Placebo (saline)
25 patients. ACB. 30 mL Saline. Ultrasound-guided application.
Procedure: Saline
Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212666


Locations
Denmark
Department of Anaesthesiology, Glostrup University Hospital
Copenhagen, Glostrup, Denmark, 2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Malene Espelund, MD Glostrup University Hospital, Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Malene Espelund, MD, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01212666     History of Changes
Other Study ID Numbers: SM1-ME-10
First Posted: October 1, 2010    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

Keywords provided by Malene Espelund, Glostrup University Hospital, Copenhagen:
Adductor Canal Block (ACB)
Anterior Cruciate Ligament (ACL) Reconstruction
Saphenous nerve
Pain
Ultrasound block