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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05370586
Other study ID # 0020199/22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 30, 2022
Est. completion date March 2023

Study information

Verified date August 2022
Source IRCCS Policlinico S. Matteo
Contact Santi Di Pietro, MD
Phone 00393463153244
Email santi.dipietro01@universitadipavia.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date March 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pericapsular nerve Group Block
Patients of study group will receive PENG block with 20 mL of 0,375% levobupivacaine with 4 mg of dexamethasone
Infrainguinal 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

Locations

Country Name City State
Italy Emergency Department, IRCCS San Matteo University Hospital Pavia Lombardia
United Kingdom Emergency Department, Colchester General Hospital Colchester

Sponsors (2)

Lead Sponsor Collaborator
IRCCS Policlinico S. Matteo Colchester General Hospital

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain relief over the 60-minutes following either block measured as the percentage of summed pain-intensity difference (%SPID) 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) Outcome assessed within 60 minutes following the block (PENG or FIB)
Secondary 33% SPID 33% (33%SPID) Number of patients who achieve a percentage of summed pain-intensity difference of 33% (33%SPID) Outcome assessed within 60 minutes following the block (PENG or FIB)
Secondary 50%SPID Number of patients who achieve a percentage of summed pain-intensity difference of 50% (50%SPID) Outcome assessed within 60 minutes following the block (PENG or FIB)
Secondary Quantity of opioids Quantity of opioids (milligrams of morphine) administered in the first 60 minutes following either block Outcome assessed within 60 minutes following the block (PENG or FIB)
Secondary Adverse events 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. Outcome assessed within 60 minutes following the block (PENG or FIB)
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