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

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ClinicalTrials.gov Identifier: NCT01254825
Recruitment Status : Completed
First Posted : December 7, 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 (ACB) is superior to placebo when it comes to analgetic efficacy after Knee-Arthroscopy.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Adductor-Canal-Block (ACB) in Patients After Knee Arthroscopy
Study Start Date : November 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
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.



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. Pain-score (VAS), patient at rest [ Time Frame: 0,1,2,4,6,8,24 hours postoperative ]
    ACB-group vs. placebo

  2. Pain-score (VAS), patient standing [ Time Frame: 1,2,4,6,8,24 hours postoperative ]
    ACB-group vs. placebo

  3. Pain-score (VAS), after 5 meters of walk [ Time Frame: 2,4,6,8,24 hours postoperative ]
    ACB-group vs. placebo

  4. Total Opioid-consumption [ Time Frame: 0-24 hours postoperative ]
    ACB-group vs. placebo-group

  5. Opioid-consumption, postoperative [ Time Frame: 0-2, 2-4, 4-6, 6-8, 8-24 hours postoperative ]
    i.v. morfin 0-2 hours postoperative tbl. morfin 2-24 hours postoperative ACB vs. placebo

  6. Postoperative Nausea and vomiting [ Time Frame: 0-1, 1-2, 2-4, 4-6, 6-8, 8-24 hours postoperative ]
    Rating-scale 0-3 ACB-group vs. placebo-group

  7. Postoperative ondansetron consumption [ Time Frame: In-hospital ]
    ACB-group vs. placebo-group

  8. Sedation [ Time Frame: 0,1,2,4,6,8,24 hours postoperative ]
    Rating-scale: 0-3 ACB-group vs. placebo-group



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Malene Espelund, MD, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01254825     History of Changes
Other Study ID Numbers: SM2-ME-10
First Posted: December 7, 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)
Diagnostic Knee Arthroscopy
Saphenous nerve
Pain
Ultrasound block