Clinical trial NCT06329752: Sciatic Nerve Block for Ankle and Leg Fracture Manipulation in the Emergency Department
Official title: Ultrasound-guided Sciatic Nerve Block for Distal Leg and Ankle Fracture Manipulation in the Emergency Department: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ankle Fractures
Leg Fracture
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional, single-arm, feasibility trial
Primary purpose: TREATMENT

Brief summary: The goal of this feasibility clinical trial is to assess the acceptability of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures.

The trial aims to assess:

* The acceptability of sciatic nerve block
* The technical feasibility of sciatic nerve block
* The technical success of sciatic nerve block
* The analgesic efficacy of sciatic nerve block

In addition to that, this study aims to

* Describe patient-reported and physician-reported satisfaction
* Assess the Adverse Event rate at 48 hours post intervention


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Confirmed radiological diagnosis of distal tibia fracture (Group 43 according to AO classification, all subtypes included); or malleolar fracture (Group 44 according to AO classification, all subtypes included); or distal fibula fracture (Group 4F3 according to AO classification, both the two subtypes included); or any combination of the fracture patterns described
* Fractures requiring manipulation in the ED to achieve temporary stabilization either as manual reduction and cast immobilization; or calcaneal pin traction (as per local policy or treating physician's preference)
* Capacity to understand the aim of the study, the potential benefits and harms of the proposed intervention
* Capacity to provide consent
* Capacity to provide a self-assessment of pain using the written VAS Scale

Exclusion Criteria:

* Fractures that do not require any form of manipulation in the ED according to the treating physician (e.g., fractures with minimal or no displacement of the bony fragments, that are immobilized in a posterior leg cast by the nursing stuff/physicians assistants without any painful manipulations of the bony fragments performed by the physician)
* Open fractures
* Perisynthetic or periprosthetic fractures
* Distal leg/ankle fractures with neurovascular compromise
* Clinical signs of compartment syndrome
* Skin infection at the needle entry sites
* Diabetic neuropathy or any other known form of neuropathy that causes reduced sensation in the sciatic and/or femoral nerve territory
* Charcot-Marie-Tooth disease
* Known allergy to local anaesthetics or opioids
* 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
* Patient's refusal to participate in the study
* BMI\>35
* Body weight \< 40 Kg

Primary outcomes:
measure: To assess the technical feasibility of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures.
timeFrame: From patient recruitment until sciatic nerve scanning (an estimated time frame of 30 minutes)
Secondary outcomes:
measure: Technical success of US-guided sciatic nerve block
timeFrame: 15 Minutes post US-guided sciatic nerve block
measure: Analgesic efficacy of US-guided sciatic nerve block
timeFrame: An estimated average time of 15 minutes after the beginning of fracture manipulation
measure: Patient-reported and physician-reported satisfaction
timeFrame: An estimated average time of 30 minutes after the beginning of fracture manipulation
Other outcomes:
measure: Safety Endpoint
timeFrame: In the first 48 hours post intervention
Locations:
city: Pavia
country: Italy
facility: Emergency Department, IRCCS Fondazione Policlinico San Matteo
Study officials:
affiliation: University of Pavia - IRCCS San Matteo University Hospital
name: Santi Di Pietro, MD
role: PRINCIPAL_INVESTIGATOR
References: