The Efficacy of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction
The Effect of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction in Day Case Surgery
1 other identifier
interventional
50
1 country
1
Brief Summary
The Purpose of this study is to determine whether Adductor-Canal-Block is superior to placebo when it comes to analgetic efficacy after reconstruction of the anterior cruciate ligament.
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 May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 26, 2010
CompletedFirst Posted
Study publicly available on registry
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedSeptember 11, 2012
September 1, 2012
1.8 years
May 26, 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 (38)
Total Opioid-consumption
0-24 hours postoperative
Postoperative Nausea and Vomiting
0 hour postoperative
Postoperative ondansetron consumption
In hospital
Pain-score (VAS), patient at rest
0 hours postoperative
Pain-score (VAS), patient at rest
1 hour postoperative
- +33 more secondary outcomes
Study Arms (2)
Adductor-Canal-Block, Ropivacain
EXPERIMENTAL25 patients. ACB. 30 mL Ropivacain 7,5 mg/mL. Ultrasound-guided application.
Adductor Canal Block, Placebo (saline)
PLACEBO COMPARATOR25 patients. ACB. 30 mL Saline. Ultrasound-guided application.
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
- Reconstruction of Anterior Cruciate Ligament
- Written consent
- ASA I-II
- 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
Copenhagen, Glostrup, 2600, Denmark
Related Publications (1)
Espelund M, Fomsgaard JS, Haraszuk J, Mathiesen O, Dahl JB. Analgesic efficacy of ultrasound-guided adductor canal blockade after arthroscopic anterior cruciate ligament reconstruction: a randomised controlled trial. Eur J Anaesthesiol. 2013 Jul;30(7):422-8. doi: 10.1097/EJA.0b013e328360bdb9.
PMID: 23549123DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Malene Espelund, MD
Glostrup University Hospital, Copenhagen
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
May 26, 2010
First Posted
October 1, 2010
Study Start
May 1, 2010
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
September 11, 2012
Record last verified: 2012-09