Dexmedetomidine for saphenous nerve blockade in patients undergoing anterior cruciate ligament replacement: a randomized, placebo-controlled, triple blinded study

Conditions: Dexmedetomidine -a selective alpha-2-receptor agonist- added to a local anaesthetic (ropivacaine) should prolong a saphenous block and the patients demand for the first analgesic. We designed a prospective, controlled, randomized, triple-blinded study with 40 patients parted into 2 groups who have to undergo anterior cruciate ligament reconstruction. Group R receives 10ml Ropivacaine 7.5mg/ml, group R%100DEX receives 10ml Ropivacaine 7,5mg/ml with 100µg Dexmedetomidine.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-000299-25-AT

Lead Sponsor: nfallkrankenhaus Salzburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Study patients between 16 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

natomical 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