Determination of the Median Local Anesthetic Dose (ED50) of prilocaine in THA with anterior approach that allows direct post-operative mobilization and will accommodate sufficient anesthesia during surgery.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Not applicable.
Background summary
Fast-Track surgery is a multimodal process to achieve better outcomes in
patient care. Surgical approaches for Total Hip Arthroplasty (THA) such as the
anterolateral supine inter-muscular approach (ASI) have evolved over the years
leading to less postoperative pain, reduction of length of stay and the
possibility of direct postoperative mobilization. To allow direct postoperative
mobilization motor- and sensory functions must be regained directly after
surgery.
Currently, intrathecally administered bupivacaine is used during THA. However,
we believe prilocaine could be a suitable alternative to bupivacaine for THA.
This study will investigate the median dose (ED50) requirements of intrathecal
prilocaine allowing THA surgery with anterior approach which can accommodate
immediate postoperative mobilization.
Study objective
Determination of the Median Local Anesthetic Dose (ED50) of prilocaine in THA
with anterior approach that allows direct post-operative mobilization and will
accommodate sufficient anesthesia during surgery.
Study design
This is an intervention study designed to find the MLAD/ED50 of prilocaine at a
certain threshold. In this study we use the up-and-down method as described by
Dixon and Massey. This is a sequential allocation model where patients receive
a dose of prilocaine according to the outcome of the preceding patient. With
the up and down method we approach the MLAD/ED50 from above leaving less
patients with inadequate anesthesia. For the cut-off point or threshold point
needed with this model we use the 95th percentile of the mean surgery time for
THA with anterior approach in order to expose less patients to inadequate
anesthesia during surgery.
Intervention
All patients receive a dose of intrathecal prilocaine predetermined by the up
and down sequential allocation.
Study burden and risks
Patients will receive their scheduled THA according to the regular planned fast
track surgery program. The up-and-down sequential allocation technique, rather
than random allocation, is chosen due to the ease with which it estimates the
mean of a sample. Starting from a known effective concentration and approaching
the ED50 from above minimizes the number of patients subjected to potentially
inadequate analgesia.
Reinier de Graafweg 3
Delft 2625 AD
NL
Reinier de Graafweg 3
Delft 2625 AD
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-002397-12-NL |
| CCMO | NL58178.098.16 |