The Efficacy of Adductor-Canal-Block (ACB) in Patients After Knee Arthroscopy
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 6, 2010
CompletedFirst Posted
Study publicly available on registry
December 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedSeptember 11, 2012
September 1, 2012
10 months
December 6, 2010
September 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain-Score (VAS) - patient standing
Pain-score messured on a Visual Analog Scale (VAS) 2 hours after adductor canal block. Patient standing. Intervention-group vs. placebo-group.
2 hours postoperative
Secondary Outcomes (8)
Pain-score (VAS), patient at rest
0,1,2,4,6,8,24 hours postoperative
Pain-score (VAS), patient standing
1,2,4,6,8,24 hours postoperative
Pain-score (VAS), after 5 meters of walk
2,4,6,8,24 hours postoperative
Total Opioid-consumption
0-24 hours postoperative
Opioid-consumption, postoperative
0-2, 2-4, 4-6, 6-8, 8-24 hours postoperative
- +3 more secondary outcomes
Study Arms (2)
Adductor-Canal-Block, Ropivacain
EXPERIMENTALAdductor-Canal-Block, 30 mL Ropivacain 7,5 mg/mL. Single dose. Ultrasound-guided application. 36 patients
Adductor-Canal-Block (ACB) - Saline
PLACEBO COMPARATORAdductor-Canal-Block, Placebo (30 mL Saline). Ultrasound-guided application. 36 patients.
Interventions
Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.
Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.
Eligibility Criteria
You may qualify if:
- years
- Knee-arthroscopy
- Written consent
- ASA I-III
- BMI 19-35
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anaesthesiology, Glostrup University Hospital
Glostrup Municipality, Copenhagen, 2600, Denmark
Related Publications (1)
Espelund M, Fomsgaard JS, Haraszuk J, Dahl JB, Mathiesen O. The efficacy of adductor canal blockade after minor arthroscopic knee surgery--a randomised controlled trial. Acta Anaesthesiol Scand. 2014 Mar;58(3):273-80. doi: 10.1111/aas.12224. Epub 2013 Nov 8.
PMID: 24205802DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Malene Espelund, MD
Glostrup University Hospital, Copenhagen, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
December 6, 2010
First Posted
December 7, 2010
Study Start
November 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 11, 2012
Record last verified: 2012-09