Median Local Anaesthetic Dose (MLAD) of intrathecal Bupivacaine in primary total knee arthroplasty

Phase 4

Completed

• Conditions: Anaesthesia; 10023213

• Registration Number: NL-OMON43405
• Lead Sponsor: Reinier de Graaf Groep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- ASA I, II or III
- 18 years or older
- Primary TKA
- Willing to participate
- Sufficient command of Dutch language

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Hypersensitivity to local anaesthetics or any of the other excipients of Bupivacaine
- Any other contraindications relate to intrathecal anaesthesia
- CNS disease, e.g. meningitis, tumor, poliomyelitis, cerebral haemorrhage
- Spinal stenosis and diseases or recent trauma to the cervical column
- Sepsis
- Pernicious anaemia 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 anaesthesia
- No Local Infiltration Anaesthesia (LIA) possible
- Patients who are incompetent to decide

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>MLAD/ED50 of Bupivacaine at t=116 minutes</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>