Pharmacokinetics of high dose Ropivacaine with and without epinephrine for combined femoral and sciatic nerve block in lower extremity surgery. A pilot study. - RopiPilot

• Conditions: combined femoral and sciatic nerve block for lower extremity orthopedic surgery

• Registration Number: EUCTR2009-013481-10-NL
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified