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

Median Local Anaesthetic dose (MLAD) of Intrathecal Prilocaïne in total hip arthroplasty with the anterior approach. - ED50 of Intrathecal prilocaine in Total Hip Arthroplasty

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42912
Enrollment
25
Registered
2016-08-11
Start date
2016-09-19
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Anaesthesia

Interventions

All patients receive a dose of intrathecal prilocaine predetermined by the up and down sequential allocation.
Median effective dose
Total hip arthroplasty

Sponsors

Reinier de Graaf Groep
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

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

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

MeasureTime frame
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

MeasureTime frame
Not applicable.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)