Spinal anesthesia during total hip arthroplasty with anterior approach
Conditions
Sponsors
Reinier de Graaf Groep
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to reach Bromage 0 Time to regain positive pinprick test at dermatome S1 and L5;Timepoint(s) of evaluation of this end point: after analysis of all patients | — |
Countries
Netherlands
Contacts
Public ContactResearch Coordinator
Reinier de Graaf Groep
Outcome results
None listed