Clinical Trials Directory

Trials / Completed

CompletedNCT05370586

PENG Block vs Fascia Iliaca Block for Emergency Department Analgesia in Hip Fractures

Pericapsular Nerve Group (PENG) Block Versus Fascia Iliaca (FIB) Block for Emergency Department Analgesia in Hip Fractures: A Randomised Controlled Trial.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
64 (actual)
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPericapsular nerve Group BlockPatients of study group will receive PENG block with 20 mL of 0,375% levobupivacaine with 4 mg of dexamethasone
OTHERInfrainguinal Fascia Iliaca BlockPatients of control group will receive an infrainguinal fascia iliaca block with 30 mL of 0,25 % levobupivacaine with 4 mg of dexamethasone

Timeline

Start date
2022-07-30
Primary completion
2024-08-16
Completion
2024-08-16
First posted
2022-05-11
Last updated
2024-10-01

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05370586. Inclusion in this directory is not an endorsement.