|- candidate number||14230|
|- NTR Number||NTR3824|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-jan-2013|
|- Secondary IDs||40963.091.12 / 2012/265; CCMO / METC|
|- Public Title||Specialized prehospital pain treatment by paramedics.|
|- Scientific Title||Fascia iliaca compartment block by paramedics as acute pain treatment for patients with suspected collum fractures. |
|- hypothesis||Trained paramedics can succesfully and effectively perform a fascia iliaca compartment block in patients with collum fractures |
|- Healt Condition(s) or Problem(s) studied||Pain relief|
|- Inclusion criteria||1. 18 years or older;|
2. Non-complicated collum or femurfracture;
3. NRS-score =4 or greater;
4. Transport by ambulance service.
|- Exclusion criteria||1. Hemodynamic instability;|
2. Decreased conciousness;
3. Nerve or vascular lesion on the affected limb;
4. Impossibillity to palpate femoral artery;
5. BMI > 30;
6. Allergy to local anesthetics;
7. Patients with severe other distracting injuries.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||15-nov-2012|
|- planned closingdate||15-nov-2013|
|- Target number of participants||100|
|- Interventions||Ten trained paramedics will receive a training in the performance of the fascia iliaca compartment block. Hereafter the paramedics will perform this peripheral nerve block in patients with a suspected femur or collumfracture in the prehospital phase.
Lidocaine 1% with adrenaline 1:200.000: 0,3 ml/kg will be injected.|
|- Primary outcome||A decrease in pain score of at least two points on a 10 point scale at arrival in the hospital. |
|- Secondary outcome||The incidence of neurological and vascular complications. The ease of the block. Patient satisfaction. |
|- Timepoints||At arrival, 10, 20 and 30 minutes after block performance. During patient transfer to transport trolley, during transportation, at arrival in the hospital and transfer to the hospital bed.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| G.J. Geffen, van|
|- CONTACT for SCIENTIFIC QUERIES|| G.J. Geffen, van|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Center Nijmegen|
|- Brief summary||Patients with suspected femur or hip fractures are often difficult to evacuate. The prehospital administered analgesics provide often insufficient painrelief or cause serious side effects. For this reason we looked for an alternative. The fascia iliaca compartment (FIC) block is a peripheral nerve block in which the femoral nerve is anesthetized.|
Routinely this technique is applied for perioperative pain relief in hip and knee surgery. But can also be applied for acute pain relief for femur and hip fractues. The FIC block was successfully performed by nurses in a hospital, but not yet in a prehospital phase. The objective of the study is to answer the question: "Can paramedics safely and effictively perform the FIC block prehospitally?"
10 paramedics will be theoretically and practically trained. Hereafter they will perform the FIC block in a prehospital situation in 100 patients with suspected femoral or hip fractures before they are transported to a hospital.
Pain scores, complications and patient satisfaction will be observed.
|- Main changes (audit trail)|
|- RECORD||18-jan-2013 - 18-dec-2013|