Hip Fractures
Conditions
Keywords
Fascia iliaca block, PENG block, Regional anaesthesia at Emergency Departments, Hip Fracture Analgesia
Brief summary
Pain management is a crucial aspect of the care of hip fracture patients. Patients with poorly controlled pain have an increased risk of delirium, long-term functional impairment, and remain hospitalized longer. Today, to relieve hip fracture pain, fascia iliaca block is routinely performed in the emergency department in addition to other pain medications administered by vein or by mouth. Several studies have questioned the analgesic efficacy of this block, suggesting the superiority of the newer PENG block. The purpose of this multicenter, randomized study is to compare the analgesic efficacy of PENG block versus fascia iliaca block, hypothesizing the superiority of the new approach over the gold standard. Participants will be blindly assigned in a 1:1 ratio to the study or control group, recruited from the Emergency Departments of IRCCS Policlinico San Matteo and Colchester Hospital (UK). The main outcome is represented by the reduction of pain after the two blocks, measured as %SPID (percentage of pain intensity difference), a value derived from VAS scale measurements in the first hour post-procedure. Secondly, we will evaluate the proportion of patients with satisfactory pain control, the amount of opioids used and the safety profile of the two approaches.
Interventions
OTHERPericapsular nerve Group Block
Patients of study group will receive PENG block with 20 mL of 0,375% levobupivacaine with 4 mg of dexamethasone
OTHERInfrainguinal Fascia Iliaca Block
Patients of control group will receive an infrainguinal fascia iliaca block with 30 mL of 0,25 % levobupivacaine with 4 mg of dexamethasone
Sponsors
Colchester General Hospital
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
andomised-controlled trial with two parallel study groups. Participants will be randomised 1:1 to the study or control group. The study group will be treated with PENG block following randomisation, whereas the control group will receive the standard treatment, i.e., fascia iliaca block. The study aims to demonstrate the superiority of the new intervention over the standard approach.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 * Capacity to understand the aim of the study, the potential benefits and side-effects of the procedures * Capacity to provide consent * Capacity to provide a self-assessment of pain using the written VAS Scale * Confirmed radiological diagnosis of hip fractures (including subcapitate, transcervical, intertrochanteric and perthrocanteric fractures) * Moderate or severe worst pain (visual analogue scale, VAS \>40 mm) (at rest or dynamic)
Exclusion criteria
* Known hypersensitivity to local anaesthetics * Confirmed radiological diagnosis of subtrochanteric or diaphyseal femur fractures * Hemodynamic instability * Known diagnosis of severe cognitive impairment * Dementia and/or delirium (defined by a 4AT score ≥ 2) * Lack of capacity to provide consent and to understand the aim of the study * BMI\>35 * Body weight \< 40 Kg * Prior hip surgery on the same fracture side * Mild worst pain (visual analogue scale, VAS \< 40 mm) (at rest or dynamic)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID) | Outcome assessed within 60 minutes following the block (PENG or FIB) | Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID) (derived from V AS measurement at T0-T1- T2-T3-T4 as described above) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 33% SPID 33% (33%SPID) | Outcome assessed within 60 minutes following the block (PENG or FIB) | Number of patients who achieve a percentage of summed pain-intensity difference of 33% (33%SPID) |
| 50%SPID | Outcome assessed within 60 minutes following the block (PENG or FIB) | Number of patients who achieve a percentage of summed pain-intensity difference of 50% (50%SPID) |
| Quantity of opioids | Outcome assessed within 60 minutes following the block (PENG or FIB) | Quantity of opioids (milligrams of morphine) administered in the first 60 minutes following either block |
| Adverse events | Outcome assessed within 60 minutes following the block (PENG or FIB) | Occurrence of adverse events including nausea or vomiting, hypotension, respiratory depression (hypoxia or hypopnea), local anaesthetic toxicity syndrome (LAST syndrome) during ED stay (post-block). Adverse event will be described, and their incidence will be presented with 95% CI and compared with Fisher test. |
Countries
Italy
Outcome results
None listed