Optimal dosage of epidural bupivacaine in hip replacement surgery

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: EUCTR2015-002958-12-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 Bupivacaine

* Any other contraindications relate to intrathecal anesthesia

* CNS disease, e.g. meningitis, tumor, poliomyelitis, cerebral haemorrhage

* 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 with intrathecal anesthesia

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 Median Local Anesthetic Dose (ED50) of bupivacaine in THA with anterior approach that allow direct post-operative mobilization and will accommodate sufficient anesthesia during surgery.;Secondary Objective: Not applicable;Primary end point(s): Bromage 0, Postive pinprick test on dermatome L5 and S1 at t=119;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