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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21564

Enrollment

Registered

2009-08-28

Start date

2009-10-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

combined femoral and sciatic nerve block for lower extremity orthopedic surgery

Interventions

Using a sealed envelope technique, patients will be randomly allocated to receive combined femoral sciatic nerve block with 60 mL of either ropivacaine 0.75% alone or ropivacaine 0.75% plus 5 mcg/mL (

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years, under 60 years of age; 2. Body Weight over 70 kg; 3. ASA classification I-III; 4. Patients undergoing combined femoral and sciatic nerve block for lower extremity orthopaedic surgery; 5. Who will be admitted for at least 48 hours; 6. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Contra-indications for regional anesthesia (infection at the injection site, coagulopathy); 2. Known hypersensitivity to amide-type local anesthetics; 3. Known history of peripheral neuropathy; 4. Hepatic or renal insufficiency; 5. Use of fluvoxamine, ciprofloxacin, ketoconazole, erythromycin, clarithromycin, itraconazole, or rifampicin because of their effect on ropivacaine clearance.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactK.P.W. Schoenmakers

Dept. of Anesthesiology Sint Maartenskliniek P.O.Box 9011

K.schoenmakers@maartenskliniek.nl+31 (0)24 365 9935

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)