combined femoral and sciatic nerve block for lower extremity orthopedic surgery
Conditions
Interventions
Trade Name: Naropin
Product Name: Ropivacaine
Product Code: 0867-59, N01BB09
Pharmaceutical Form: Injection*
Sponsors
Sint Maartenskliniek
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients = 18 years, = 60 years - Body Weight = 70 kg - ASA classification I – III - Patients undergoing combined femoral and sciatic nerve block for lower extremity orthopaedic surgery - Who will be admitted for at least 48 hours - Written informed consent 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Contra-indications for regional anesthesia (infection at the injection site, coagulopathy) - Known hypersensitivity to amide-type local anesthetics - Known history of peripheral neuropathy - Hepatic or renal insufficiency - Use of fluvoxamine, ciprofloxacin, ketoconazole, erythromycin, clarithromycin, itraconazole, or rifampicin because of their effect on ropivacaine clearance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the present pilot study is to obtain a pharmacokinetic profile of ropivacaine in serum with epinephrine, and of ropivacaine in serum without epinephrine, used for high dosed combined femoral and sciatic nerve block in lower extremity orthopedic surgery. Results of this pilot study will be used in a follow-up study to determine block specific maximum doses using the determined width of Cmax found in this study.;Secondary Objective: not applicable;Primary end point(s): 1. Mean unbound and bound peak plasma concentration (Cmax) of ropivacaine with and without epinephrine 2. Mean time to unbound and bound peak plasma concentration (Tmax) of ropivacaine with and without epinephrine 3. Range of duration (width) of Cmax¬ after single shot combined femoral and sciatic nerve block with and without epinephrine 4. Range of apparent half-life of ropivacaine with and without epinephrine in combined femoral and sciatic nerve block (T½). 5. Efficacy of the sensory blockade with and without epinephrine. 6. Duration of the sensory blockade with and without epinephrine. | — |
Countries
Netherlands
Outcome results
None listed