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.
Conditions
Interventions
Trade Name: Dexdor
Product Name: Dexmedetomidine
Product Code: EU/1/11/718/001
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Dexmedetomidine
CAS Number: 145108-58-3
O
Sponsors
Unfallkrankenhaus Salzburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Study patients between 16 and 60 years - ASA physical status 1-2 - BMI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate the clinical use of 100µg dexmedetomidine (a selective alpha-2-receptor agonistic drug) as an adjuvant to ropivacaine for saphenous nerve blockade. ;Secondary Objective: We will describe the effects of dexmedetomidine on use of analgesics and will evaluate its side effects when used for saphenous nerve blockade. ;Primary end point(s): duration of sensory block defined by demand for first analgesic;Timepoint(s) of evaluation of this end point: Prior the block, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 30 min. No Pinprick-related sensory evaluation will be performed during and after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Successful blockade of the saphenous nerve block determined by pin-prick testing in the area of sensory supply (medial malleolus) - Onset time of sensory block - Haemodynamic parameters (mean arterial blood pressure, heart rate) - State of vigilance defined by the Richmond Agitation and Sedation Score (RASS) - Plasma levels of dexmedetomidine (30, 90 and 180 minutes after blockade);Timepoint(s) of evaluation of this end point: - Block success: sensory onset time = 60 min (when all above defined parts of the saphenous nerve show a Pinprick = 10% compared to contralateral side) - Duration of sensory block: time period from performance of saphenous nerve block to first analgesic demand (by i.v. PCA self-administration) - Time until maximum sedation level: time from performance of saphenous nerve block to maximum sedation level (RASS score) Duration of sedation: Time from RASS score = -1 until RASS score = 0 | — |
Countries
Austria
Contacts
Public ContactLukas Kirchmair
Unfallkrankenhaus Salzburg
Outcome results
None listed