The optimal dose of spinal anaesthesia during total hip arthroplasty with the anterior approach.

Phase 1

Conditions: Spinal anesthesia during total hip arthroplasty with anterior approach
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2016-002397-12-NL

Lead Sponsor: Reinier de Graaf Groep

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determination of the ED50 (95%CI) of prilocaine administered intrathecally in THA with anterior approach that allows direct post-operative mobilization and will accommodate sufficient anesthesia during surgery. ;Secondary Objective: Not applicable;Primary end point(s): Bromage 0, positive pinprick test on dermatome L5 and S1 at t=124;Timepoint(s) of evaluation of this end point: After analysis of all patients

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Time to reach Bromage 0<br>- Time to regain positive pinprick test at dermatome S1 and L5;Timepoint(s) of evaluation of this end point: After analysis of all patients