Ankle FracturesAnkleManNCT06329752
Sciatic Nerve Block for Ankle and Leg Fracture Manipulation in the Emergency Department
A study testing Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine) in people with Ankle Fractures and Leg Fracture, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fractures, Leg Fracture
- What is being tested?
- Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- May 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Emergency Department, IRCCS Fondazione Policlinico San Matteo
Pavia, 27100
Santi Di Pietro, 3463153244, santi.dipietro@unipv.it
About this study
Official title: 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
- Conditions
- Ankle Fractures, Leg Fracture
- Being tested
- Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine)
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Sciatic Nerve block Arm (Single Arm) | Experimental | Not described Receives: Procedure: Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Percentage of patients treated with sciatic nerve block who develop complete or mild- score 0 or 1 - sensory deficit 15 minutes post block
Measured: 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
Measured: 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.
Measured: An estimated average time of 30 minutes after the beginning of fracture manipulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional, single-arm, feasibility trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santi Di Pietro, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Santi Di Pietro, MD, Principal investigator, University of Pavia - IRCCS San Matteo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329752
- Sponsor's protocol ID
- Not available yet
- Acronym
- AnkleMan
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Sciatic Nerve Block for Distal Leg and Ankle Fracture Manipulation in the Emergency Department: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06329752
- Acronym / sponsor ID
- AnkleMan / Not available yet
- Conditions
- Ankle Fractures, Leg Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional, single-arm, feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Sciatic Nerve block Arm (Single Arm) | Experimental | Procedure: Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Sciatic Nerve block Arm (Single Arm) |
Primary outcome
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.
Time frame: 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
3 secondary outcomes
Technical success of US-guided sciatic nerve block
Time frame: 15 Minutes post US-guided sciatic nerve block
Analgesic efficacy of US-guided sciatic nerve block
Time frame: An estimated average time of 15 minutes after the beginning of fracture manipulation
Patient-reported and physician-reported satisfaction
Time frame: An estimated average time of 30 minutes after the beginning of fracture manipulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santi Di Pietro, MD principal investigator
University of Pavia - IRCCS San Matteo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine) in people with Ankle Fractures and Leg Fracture, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Santi Di Pietro, MD (+39 0382 502750, santi.dipietro@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: From patient recruitment until sciatic nerve scanning (an estimated time frame of 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.