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
  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:


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
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: 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 September 11, 2014