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

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002397-12-NL

Enrollment

Unknown

Registered

2016-07-25

Start date

2016-08-11

Completion date

Unknown

Last updated

2016-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal anesthesia during total hip arthroplasty with anterior approach

Interventions

Trade Name: Prilotekal 20 mg/ml oplossing voor injectie Product Name: Prilotekal 20 mg/ml Product Code: RVG 112995 Pharmaceutical Form: Solution for injection

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 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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

n.mathijssen@rdgg.nl00310152603718

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026