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Farmacokinetiek van ropivacaïne met en zonder adrenaline bij hoge doseringen voor n. femoralis en ischiadicus blok bij orthopedische chirurgie van de onderste extremiteit.

Completed
Conditions
combined femoral and sciatic nerve block for lower extremity orthopedic surgery
Registration Number
NL-OMON21564
Lead Sponsor
Sint Maartenskliniek Nijmegen, The Netherlands
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
12
Inclusion Criteria

1. Patients over 18 years, under 60 years of age;

2. Body Weight over 70 kg;

Exclusion Criteria

1. Contra-indications for regional anesthesia (infection at the injection site, coagulopathy);

2. Known hypersensitivity to amide-type local anesthetics;

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Mean unbound and bound peak plasma concentration (Cmax) of ropivacaine with and without epinephrine;<br /><br>2. Mean time to unbound and bound peak plasma concentration (Tmax) of ropivacaine with and without epinephrine;<br /><br>3. Range of duration (width) of Cmax¬ after single shot combined femoral and sciatic nerve block with and without epinephrine;<br /><br>4. Range of apparent half-life of ropivacaine with and without epinephrine in combined femoral and sciatic nerve block (T½);<br /><br>5. Efficacy of the sensory blockade with and without epinephrine;<br /><br>6. Duration of the sensory blockade with and without epinephrine.
Secondary Outcome Measures
NameTimeMethod
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