Hyperbaric Prilocaine 2% for spinal anesthesia 60 or 80 mg: a dosing study in day care patients.
Phase 4
Completed
- Conditions
- lokaal anesthesie tbv operatieve ingrepen in dagbehandelingback injectionspinal anesthesia
- Registration Number
- NL-OMON47932
- Lead Sponsor
- anesthesiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Patients requiring spinal anesthesia for lower limb surgery in day case
surgery.
Exclusion Criteria
age younger than 18 yrs
pregnancy
allergy for prilocaine or other amide type local anesthetics
hereditary or acquired methaemoglobinaemia
severe heart conduction abnormalities *
severe anaemia *
unstable cardiac failure *
hypovolemic, cardiogenic or other forms of circulatory shock *
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Maximum block height (sensibility and motor) Time of regression to T10, L1 and<br /><br>S2 (sensibility)<br /><br>Time of regression of motor block<br /><br>Time to spontaneous urination or catherization</p><br>
- Secondary Outcome Measures
Name Time Method <p>the amount of fluid infused during and after surgery and the amount of fluids<br /><br>taken postoperatively<br /><br>bladder volume pre and postoperatively and at discharge if the patient did not<br /><br>urinate yet<br /><br>time of first urine production. If the patient does not urinate during<br /><br>admission, he/she will be asked to record the time at home<br /><br>bladder catheterization if necessary and volume additional analgesics per and<br /><br>postoperatively use of vasopressors<br /><br>patient satisfaction with the procedure<br /><br>time of discharge, night admission if necessary and reason for night admission<br /><br><br /><br><br /><br><br /><br>****</p><br>