We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01254825
First Posted: December 7, 2010
Last Update Posted: September 11, 2012
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.
Information provided by (Responsible Party):
Malene Espelund, Glostrup University Hospital, Copenhagen
  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
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

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

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

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

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

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

  • 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

  • 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

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

  • Sedation [ Time Frame: 0,1,2,4,6,8,24 hours postoperative ]
    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

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 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
  Contacts and Locations
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
  More Information

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 Submitted: December 6, 2010
First Posted: December 7, 2010
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


To Top