Dexmedetomidine for saphenous nerve blockade!in patients undergoing anterior cruciate ligamentreplacement:A randomized, placebo-controlled,Triple'Blinded'Study

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 40

Inclusion Criteria

Study patients between 18 and 60 years
- ASA physical status 1-2
- BMI < 30 kg/m2
- Scheduled for posttraumatic ACLR
- Written informed consent given by study patients after being provided with detailed
information about the nature, risks, and scope of the clinical study as well as the
expected desirable and adverse effects of the drugs
- No legal incapacity and/or other circumstances rendering the study patients unable to
understand the nature, scope and possible consequences of the study

Exclusion Criteria

-Anatomical abnormalities of the respective lower extremity identified by physical
examination or ultrasound
- Known allergy or hypersensitivity to ropivacaine or other amino-amide LA
-Known allergy or hypersensitivity to dexmedetomidine
- Participation in another clinical study within the last 4 weeks prior to study
- Coagulopathy
- Abnormalities in Blood pressure (Hypotension with a systolic BP < 90 mmHg and
hypertension with a systolic BP > 180 mmHg) during evaluation of eligibility for
study participation
- Coronary heart disease with an CCS III and higher
- Chronic heart failure NYHA III and higher
- Chronic opioid consumption exceeding a morphine-equivalent dose of 15mg per day
- Bradycardia with a heart rate after 5 min resting of < 40 b/min
- Abnormalities in ECG that are considered clinically relevant like AV-block 2nd degree
and higher
- Unreliability and/or lack of cooperation
- Other objections to participate in the study in the opinion of the investigator

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Opioid consumption during the first 24 hours (self administration via PCA pump)

Secondary Outcome Measures

Name	Time	Method
-Success rate of saphenous nerve block determined by pin-prick testing in the area of<br>sensory supply<br>- Onset time of sensory block<br>- Haemodynamic parameters (mean arterial blood pressure, heart rate)<br>- Time to first rescue analgesia<br>- Pain scores during the first 24 hours assessed by numeric rating scale (NRS) every 30 minutes in PACU(=postoperative care unit)<br>- State of vigilance defined by the Richmond Agitation and Sedation Score (RASS) every 30 minutes in PACU <br>- Plasma levels of dexmedetomidine (30, 90 and 180 minutes after blockade) post injection

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