Sciatic Nerve Block for Ankle and Leg Fracture Manipulation in the Emergency Department

Not Applicable

Not yet recruiting

• Conditions: Ankle Fractures; Leg Fracture
• Interventions: Procedure: Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine)

• Registration Number: NCT06329752
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-20
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-26
• Last Update Posted: 2024-03-26
• Study Start: 2024-05
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sciatic Nerve block Arm (Single Arm)	Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine)	-

Primary Outcome Measures

Name	Time	Method
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.	From patient recruitment until sciatic nerve scanning (an estimated time frame of 30 minutes)	Percentage of patients for whom the block is deemed technically feasible by the investigator in charge of this task

Secondary Outcome Measures

Name	Time	Method
Technical success of US-guided sciatic nerve block	15 Minutes post US-guided sciatic nerve block	Percentage of patients treated with sciatic nerve block who develop complete or mild- score 0 or 1 - sensory deficit 15 minutes post block
Analgesic efficacy of US-guided sciatic nerve block	An estimated average time of 15 minutes after the beginning of fracture manipulation	Percentage of patients manipulated after a successful sciatic nerve block who report Pain Max \< 40 mm
Patient-reported and physician-reported satisfaction	An estimated average time of 30 minutes after the beginning of fracture manipulation	Patient's satisfaction and Treating physician's satisfaction assessed with a 5-points Likert scale.

Trial Locations

Locations (1)

Emergency Department, IRCCS Fondazione Policlinico San Matteo; 🇮🇹 Pavia, Italy