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

Ultrasound-guided Sciatic Nerve Block for Distal Leg and Ankle Fracture Manipulation in the Emergency Department: A Feasibility Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Ankle Fractures; Leg Fracture
• Intervention / Treatment: Procedure: Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Santi Di Pietro, MD; Phone Number: +39 0382 502750; Email: santi.dipietro@unipv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Emergency Department, IRCCS Fondazione Policlinico San Matteo
    • Contact: Santi Di Pietro; Phone Number: 3463153244; Email: santi.dipietro@unipv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sciatic Nerve block Arm (Single Arm)

Procedure: Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine); Patients will be scanned with the ultrasound machine to determine the technical feasibility of sciatic nerve blocks. If feasible, one of the following techniques will be performed a) popliteal sciatic nerve block, with either lateral or posterior approach; b) CAPS (crosswise approach to popliteal sciatic) block, with either lateral to medial or anterolateral to posteromedial approach; c) subgluteal sciatic nerve block; d) transgluteal sciatic nerve block. In all cases, 20 mL of 2% Lidocaine will be used.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success of 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	15 Minutes post US-guided sciatic nerve block
Analgesic efficacy of US-guided sciatic nerve block	Percentage of patients manipulated after a successful sciatic nerve block who report Pain Max < 40 mm	An estimated average time of 15 minutes after the beginning of fracture manipulation
Patient-reported and physician-reported satisfaction	Patient's satisfaction and Treating physician's satisfaction assessed with a 5-points Likert scale.	An estimated average time of 30 minutes after the beginning of fracture manipulation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint	Number and type of adverse events in the first 48 hours post intervention	In the first 48 hours post intervention

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo
• Investigators: Principal Investigator: Santi Di Pietro, MD, University of Pavia - IRCCS San Matteo University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Disease Attributes; Ankle Injuries; Emergencies; Fractures, Bone; Ankle Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Not available yet

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No