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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Malene Espelund, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01212666
First received: May 26, 2010
Last updated: September 9, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Anterior Cruciate Ligament Reconstruction
Procedure: Ropivacain
Procedure: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Pain-score (VAS), patient standing [ Time Frame: 2 hours postoperative ] [ Designated as safety issue: No ]
    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:
  • Total Opioid-consumption [ Time Frame: 0-24 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo-group

  • Postoperative Nausea and Vomiting [ Time Frame: 0 hour postoperative ] [ Designated as safety issue: No ]
    Levels of nausea (0-3). ACB-group vs. placebo-group

  • Postoperative ondansetron consumption [ Time Frame: In hospital ] [ Designated as safety issue: No ]
  • Pain-score (VAS), patient at rest [ Time Frame: 0 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), patient at rest [ Time Frame: 1 hour postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), patient at rest [ Time Frame: 2 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), patient at rest [ Time Frame: 4 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), patient at rest [ Time Frame: 6 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), patient at rest [ Time Frame: 8 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), patient at rest [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), patient standing [ Time Frame: 1 hour postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), patient standing [ Time Frame: 2 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), patient standing [ Time Frame: 4 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), patient standing [ Time Frame: 6 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), patient standing [ Time Frame: 8 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), patient standing [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), after 5 meters of walk [ Time Frame: 2 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), after 5 meters of walk [ Time Frame: 4 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), after 5 meters of walk [ Time Frame: 6 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), after 5 meters of walk [ Time Frame: 8 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), after 5 meters of walk [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Postoperative Nausea and Vomiting [ Time Frame: 1 hours postoperative ] [ Designated as safety issue: No ]
    Levels of nausea (0-3). ACB-group vs. placebo-group

  • Postoperative Nausea and Vomiting [ Time Frame: 2 hours postoperative ] [ Designated as safety issue: No ]
    Levels of nausea (0-3). ACB-group vs. placebo-group

  • Postoperative Nausea and Vomiting [ Time Frame: 4 hours postoperative ] [ Designated as safety issue: No ]
    Levels of nausea (0-3). ACB-group vs. placebo-group

  • Postoperative Nausea and Vomiting [ Time Frame: 6 hours postoperative ] [ Designated as safety issue: No ]
    Levels of nausea (0-3). ACB-group vs. placebo-group

  • Postoperative Nausea and Vomiting [ Time Frame: 8 hours postoperative ] [ Designated as safety issue: No ]
    Levels of nausea (0-3). ACB-group vs. placebo-group

  • Postoperative Nausea and Vomiting [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
    Levels of nausea (0-3). ACB-group vs. placebo-group

  • Sedation [ Time Frame: 0, hour postoperative ] [ Designated as safety issue: No ]
    Levels of sedation (0-3). ACB-group vs. placebo

  • Sedation [ Time Frame: 1 hour postoperative ] [ Designated as safety issue: No ]
    Levels of sedation (0-3). ACB-group vs. placebo

  • Sedation [ Time Frame: 2 hours postoperative ] [ Designated as safety issue: No ]
    Levels of sedation (0-3). ACB-group vs. placebo

  • Sedation [ Time Frame: 4 hours postoperative ] [ Designated as safety issue: No ]
    Levels of sedation (0-3). ACB-group vs. placebo

  • Sedation [ Time Frame: 6 hours postoperative ] [ Designated as safety issue: No ]
    Levels of sedation (0-3). ACB-group vs. placebo

  • Sedation [ Time Frame: 8 hours postoperative ] [ Designated as safety issue: No ]
    Levels of sedation (0-3). ACB-group vs. placebo

  • Sedation [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
    Levels of sedation (0-3). ACB-group vs. placebo

  • Postoperative Nausea and Vomiting [ Time Frame: 0 hours postoperative ] [ Designated as safety issue: No ]
    Levels of nausea (0-3). ACB-group vs. placebo-group

  • Pain (VAS) at rest, 0-24 hours postoperative (AUC) [ Time Frame: 0-24 h postoperative ] [ Designated as safety issue: No ]
    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.

  • Pain (VAS), patient standing, 1-24 hours postoperative (AUC) [ Time Frame: 1-24 hours postoperative ] [ Designated as safety issue: No ]
    Pain-score messured on a Visual Analog Scale (VAS) 1-24 hours after adductor canal block (AUC). Patient standing. Intervention-group vs. placebo-group.

  • Pain (VAS), pain after 5 meters of walk, 2-24 hours postoperative (AUC) [ Time Frame: 2-24 hours postoperative ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: May 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Glostrup University Hospital, Copenhagen

Additional 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
Study First Received: May 26, 2010
Last Updated: September 9, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014