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Optimal dosage of epidural bupivacaine in knee replacement surgery

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-000082-23-NL
Enrollment
Unknown
Registered
2016-02-15
Start date
2016-03-11
Completion date
Unknown
Last updated
2016-04-11

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

Conditions

Spinal anaesthesia during total knee arthroplasty

Interventions

Trade Name: Marcaine 5mg/ml spinaal Product Name: Marcaine 5mg/ml spinaal Product Code: RVG 10970 Pharmaceutical Form: Solution for injection

Sponsors

Reinier de Graaf Groep
Lead Sponsor

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, II or III - 18 years or older - primary total knee arthroplasty - willing to participate - sufficient command of Dutch 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 anaesthetics or any of the other excipients of Bupivacaine - Any other contraindications relate to intrathecal anaesthesia - CNS disease, e.g. menigitis, 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 anaesthesia - No Local Infiltration Anaesthesia (LIA) possible - Patients who are incompetent to decide

Design outcomes

Primary

MeasureTime frame
Secondary Objective: not applicable;Primary end point(s): Bromage 0, positive pinprick test on dermatome L5 and S1 at t=116;Timepoint(s) of evaluation of this end point: after analysis of all patients;Main Objective: Determination of the Median Local Anaesthetic Dose (ED50) of bupivacaine in TKA, that allow direct post-operative mobilization and will accommodate sufficient anaesthesia during surgery.—

Secondary

MeasureTime 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 patiënts—

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