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Median Local Anaesthetic dose (MLAD) of Intrathecal Prilocaïne in total hip arthroplasty with the anterior approach.

Phase 4
Completed
Conditions
Anaesthesia
10023213
Registration Number
NL-OMON42912
Lead Sponsor
Reinier de Graaf Groep
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
25
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:;- ASA I to III
- 18y or older
- Primary uncemented THA with anterior approach
- Willing to participate
- Speaking Dutch language

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:;- Hypersensitivity to local anesthetics or any of the other excipients of prilocaine
- Any other contraindications relate to intrathecal anesthesia
- CNS disease, e.g. meningitis, tumor, poliomyelitis, cerebral hemorrhage
- Spinal stenosis and diseases or recent trauma to the cervical column
- Sepsis
- Pernicious anemia with symptoms related to cervical degradation
- Pyogenic infections of the skin close to the injection site
- Cardiogenic or hypovolemic shock
- Disturbance in coagulation or treatment with anti-coagulants
- Patient is participating in a medicinal study
- Noncompliant to intrathecal anesthesia
- Patients who are incompetent to decide

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Determination of the ED50 (95%CI) of prilocaine administered intrathecally in<br /><br>THA with anterior approach that allows direct post-operative mobilization and<br /><br>will accommodate sufficient anesthesia during surgery. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Not applicable.</p><br>
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