Pain Relief in Proximal Femoral Fracture Clinical Trial
Official title:
Analgesic Efficacy of PENG Block Compared to FIB Block in the Elderly Patient With Fracture of the Proximal Femur in the Emergency Room
| Verified date | September 2021 |
| Source | Santo Spirito Hospital, Italy |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | September 19, 2021 |
| Est. primary completion date | September 19, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years to 105 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Santo Spirito Hospital | Rome |
| Lead Sponsor | Collaborator |
|---|---|
| Santo Spirito Hospital, Italy |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain). | 30 minutes after the placement of nerve block | |
| Secondary | Onset time and duration of nerve blockade | First request of analgesic medication after blockade | from 30 minutes to 12 hours | |
| Secondary | Evaluation of rest and incident pain | Numeric Rating Scale (NRS-score) evaluation, from 0 (no pain) to 10 (worst pain) | 30 minutes after the placement of nerve block | |
| Secondary | Use of rescue-medication in pain treatment | Analgesic drugs administered at the request of the patient in the case of blockade failure | from 30 minutes to 12 hours | |
| Secondary | Check for any complications related to analgesic (PENG and FIB) blocks | Recording of any complications related to PENG and FIB blocks | from 30 minutes to 12 hours |