Pharmacokinetics of high dose Ropivacaine with and without epinephrine for combined femoral and sciatic nerve block in lower extremity surgery. A pilot study.
Phase 4
- Conditions
- orthopaedic surgery of the lower extremity10005944
- Registration Number
- NL-OMON33042
- Lead Sponsor
- Sint Maartenskliniek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
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
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
- Known hepatic or renal insufficiency
- Use of fluvoxamine, ciprofloxacin, ketoconazole, erythromycin, clarithromycin, itraconazole, or rifampicin because of their effect on ropivacaine clearance.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Mean unbound and bound peak plasma concentration (Cmax) of ropivacaine with<br /><br>and without<br /><br>epinephrine<br /><br>2. Mean time to unbound and bound peak plasma concentration (Tmax) of<br /><br>ropivacaine with and<br /><br>without epinephrine<br /><br>3. Range of duration (width) of Cmax after single shot combined femoral and<br /><br>sciatic nerve block with<br /><br>and without epinephrine<br /><br>4. Range of apparent half-life of ropivacaine with and without epinephrine in<br /><br>combined femoral and<br /><br>sciatic nerve block (T*).<br /><br>5. Efficacy of the sensory blockade with and without epinephrine.<br /><br>6. Duration of the sensory blockade with and without epinephrine.</p><br>
- Secondary Outcome Measures
Name Time Method <p>age, length, weight and gender<br /><br>possible complications or side effects</p><br>