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The Efficacy of Adductor-Canal-Block (ACB) in Patients After Knee Arthroscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Malene Espelund, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01254825
First received: December 6, 2010
Last updated: September 9, 2012
Last verified: September 2012
History of Changes
  Purpose

The Purpose of this study is to determine whether Adductor-Canal-Block (ACB) is superior to placebo when it comes to analgetic efficacy after Knee-Arthroscopy.


Condition Intervention Phase
Meniscus Lesion
Pain (Knee)
Diagnostic Knee Artroscopy
Minor Knee Surgery
 Procedure: Adductor-Canal-Block, Ropivacain
Procedure: Adductor Canal Block, Placebo (saline)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Adductor-Canal-Block (ACB) in Patients After Knee Arthroscopy

Resource links provided by NLM:

U.S. FDA Resources

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:
  • Pain-score (VAS), patient at rest [ Time Frame: 0,1,2,4,6,8,24 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), patient standing [ Time Frame: 1,2,4,6,8,24 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Pain-score (VAS), after 5 meters of walk [ Time Frame: 2,4,6,8,24 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo

  • Total Opioid-consumption [ Time Frame: 0-24 hours postoperative ] [ Designated as safety issue: No ]
    ACB-group vs. placebo-group

  • Opioid-consumption, postoperative [ Time Frame: 0-2, 2-4, 4-6, 6-8, 8-24 hours postoperative ] [ Designated as safety issue: No ]
    i.v. morfin 0-2 hours postoperative tbl. morfin 2-24 hours postoperative ACB vs. placebo

  • Postoperative Nausea and vomiting [ Time Frame: 0-1, 1-2, 2-4, 4-6, 6-8, 8-24 hours postoperative ] [ Designated as safety issue: No ]
    Rating-scale 0-3 ACB-group vs. placebo-group

  • Postoperative ondansetron consumption [ Time Frame: In-hospital ] [ Designated as safety issue: No ]
    ACB-group vs. placebo-group

  • Sedation [ Time Frame: 0,1,2,4,6,8,24 hours postoperative ] [ Designated as safety issue: No ]
    Rating-scale: 0-3 ACB-group vs. placebo-group


Enrollment: 72
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adductor-Canal-Block, Ropivacain
Adductor-Canal-Block, 30 mL Ropivacain 7,5 mg/mL. Single dose. Ultrasound-guided application. 36 patients
 Procedure: Adductor-Canal-Block, Ropivacain
Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.
Other Name: Naropin (Ropivacain)
Placebo Comparator: Adductor-Canal-Block (ACB) - Saline
Adductor-Canal-Block, Placebo (30 mL Saline). Ultrasound-guided application. 36 patients.
 Procedure: Adductor Canal Block, Placebo (saline)
Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-80 years
  • Knee-arthroscopy
  • Written consent
  • ASA I-III
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254825

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

No publications provided

Responsible Party: Malene Espelund, MD, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01254825     History of Changes
Other Study ID Numbers: SM2-ME-10
Study First Received: December 6, 2010
Last Updated: September 9, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Denmark: National Board of Health

Keywords provided by Glostrup University Hospital, Copenhagen:
Adductor Canal Block (ACB)
Diagnostic Knee Arthroscopy
Saphenous nerve
Pain
Ultrasound block

ClinicalTrials.gov processed this record on June 17, 2013