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

NCT06329752 | Not Yet Recruiting

• 1 other identifier: Not available yet
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Ankle Fractures; Leg Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Technical success of US-guided sciatic nerve block

  15 Minutes post US-guided sciatic nerve block

• Analgesic efficacy of US-guided sciatic nerve block

  An estimated average time of 15 minutes after the beginning of fracture manipulation

• Patient-reported and physician-reported satisfaction

  An estimated average time of 30 minutes after the beginning of fracture manipulation

Other Outcomes (1)

• Safety Endpoint

  In the first 48 hours post intervention

Study Arms (1)

Sciatic Nerve block Arm (Single Arm)

EXPERIMENTAL

Procedure: Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine)

Interventions

Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine) PROCEDURE

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.

Sciatic Nerve block Arm (Single Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Emergency Department, IRCCS Fondazione Policlinico San Matteo

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Ankle Fractures

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Santi Di Pietro, MD

  University of Pavia - IRCCS San Matteo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Santi Di Pietro, MD

CONTACT

+39 0382 502750; santi.dipietro@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Consultant

Model Details: Interventional, single-arm, feasibility trial

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 26, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)