Clinical trial NCT01212666: The Efficacy of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction
Official title: The Effect of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction in Day Case Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Adductor Canal Block (ACB)
Anterior Cruciate Ligament (ACL) Reconstruction
Saphenous nerve
Pain
Ultrasound block
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2010-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 18-70 years
* Reconstruction of Anterior Cruciate Ligament
* Written consent
* ASA I-II
* 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

Primary outcomes:
measure: Pain-score (VAS), patient standing
timeFrame: 2 hours postoperative
Secondary outcomes:
measure: Total Opioid-consumption
timeFrame: 0-24 hours postoperative
measure: Postoperative Nausea and Vomiting
timeFrame: 0 hour postoperative
measure: Postoperative ondansetron consumption
timeFrame: In hospital
measure: Pain-score (VAS), patient at rest
timeFrame: 0 hours postoperative
measure: Pain-score (VAS), patient at rest
timeFrame: 1 hour postoperative
measure: Pain-score (VAS), patient at rest
timeFrame: 2 hours postoperative
measure: Pain-score (VAS), patient at rest
timeFrame: 4 hours postoperative
measure: Pain-score (VAS), patient at rest
timeFrame: 6 hours postoperative
measure: Pain-score (VAS), patient at rest
timeFrame: 8 hours postoperative
measure: Pain-score (VAS), patient at rest
timeFrame: 24 hours postoperative
measure: Pain-score (VAS), patient standing
timeFrame: 1 hour postoperative
measure: Pain-score (VAS), patient standing
timeFrame: 2 hours postoperative
measure: Pain-score (VAS), patient standing
timeFrame: 4 hours postoperative
measure: Pain-score (VAS), patient standing
timeFrame: 6 hours postoperative
measure: Pain-score (VAS), patient standing
timeFrame: 8 hours postoperative
measure: Pain-score (VAS), patient standing
timeFrame: 24 hours postoperative
measure: Pain-score (VAS), after 5 meters of walk
timeFrame: 2 hours postoperative
measure: Pain-score (VAS), after 5 meters of walk
timeFrame: 4 hours postoperative
measure: Pain-score (VAS), after 5 meters of walk
timeFrame: 6 hours postoperative
measure: Pain-score (VAS), after 5 meters of walk
timeFrame: 8 hours postoperative
measure: Pain-score (VAS), after 5 meters of walk
timeFrame: 24 hours postoperative
measure: Postoperative Nausea and Vomiting
timeFrame: 1 hours postoperative
measure: Postoperative Nausea and Vomiting
timeFrame: 2 hours postoperative
measure: Postoperative Nausea and Vomiting
timeFrame: 4 hours postoperative
measure: Postoperative Nausea and Vomiting
timeFrame: 6 hours postoperative
measure: Postoperative Nausea and Vomiting
timeFrame: 8 hours postoperative
measure: Postoperative Nausea and Vomiting
timeFrame: 24 hours postoperative
measure: Sedation
timeFrame: 0, hour postoperative
measure: Sedation
timeFrame: 1 hour postoperative
measure: Sedation
timeFrame: 2 hours postoperative
measure: Sedation
timeFrame: 4 hours postoperative
measure: Sedation
timeFrame: 6 hours postoperative
measure: Sedation
timeFrame: 8 hours postoperative
measure: Sedation
timeFrame: 24 hours postoperative
measure: Postoperative Nausea and Vomiting
timeFrame: 0 hours postoperative
measure: Pain (VAS) at rest, 0-24 hours postoperative (AUC)
timeFrame: 0-24 h postoperative
measure: Pain (VAS), patient standing, 1-24 hours postoperative (AUC)
timeFrame: 1-24 hours postoperative
measure: Pain (VAS), pain after 5 meters of walk, 2-24 hours postoperative (AUC)
timeFrame: 2-24 hours postoperative
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anaesthesiology, Glostrup University Hospital
state: Glostrup
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Malene Espelund, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.