Pain Relief in Proximal Femoral Fracture
Conditions
Brief summary
The trial aims to verify a possible greater analgesic efficacy of PENG (Pericapsular Nerve Group) block compared to iliac fascia block (FIB block) in elderly patients (age \> 65 years) suffering from traumatic fracture of proximal femur in emergency room.
Detailed description
Prospective randomized double-blind single-center preliminary study aimed to demonstrate a possible greater analgesic efficacy of the PENG block compared to the iliac fascia block (FIB block) in elderly patients (age \> 65 years) suffering from traumatic fracture of the proximal femur in emergency room. The study will cover patients aged \> 65 years suffering from a proximal traumatic fracture of the femur who access the emergency room of Santo Spirito Hospital in Rome (ASL Roma 1).
Interventions
PROCEDURERegional Anesthesia - Nerve Blocks
Regional Anesthesia and ultrasound-guided nerve blocks
Sponsors
Santo Spirito Hospital, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 105 Years
Healthy volunteers
No
Inclusion criteria
* all patients \> 65 years suffering from a proximal traumatic fracture of a femur who access the emergency room of Santo Spirito Hospital in Rome (ASL Rome 1), for whom surgical treatment of osteosynthesis is recommended within 48 hours in accordance with the guidelines of Regional Health System (Regione Lazio).
Exclusion criteria
* Failure to acquire written and valid informed consent * ASA \> 3 * Obesity (BMI\> 35 kg / m2) * Contraindications to performing regional anesthesia (severe coagulopathies and / or thrombocytopenia, septic state and / or infections at the block site, allergy to local anesthetics) * Patients on therapy with antiplatelet agents, anticoagulants or who regularly use opioids, NSAIDs, acetaminophen for chronic painful conditions; * History of alcohol or drug abuse; * Severe kidney or liver failure; * Cognitive alterations, dementia, psychiatric pathologies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of success rate of PENG block (defined as NRS score </ = 4 at 30 minutes from the blockade placement by comparing it to the analgesic effect of the FIB block, also evaluated at 30 minutes as NRS score </ = 4). | 30 minutes after the placement of nerve block | Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset time and duration of nerve blockade | from 30 minutes to 12 hours | First request of analgesic medication after blockade |
| Evaluation of rest and incident pain | 30 minutes after the placement of nerve block | Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain) |
| Use of rescue-medication in pain treatment | from 30 minutes to 12 hours | Analgesic drugs administered at the request of the patient in the case of blockade failure |
| Check for any complications related to analgesic (PENG and FIB) blocks | from 30 minutes to 12 hours | Recording of any complications related to PENG and FIB blocks |
Countries
Italy
Outcome results
None listed