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

Launched by FONDAZIONE IRCCS POLICLINICO SAN MATTEO DI PAVIA · Mar 21, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a technique called a sciatic nerve block, which is a way to help manage pain for patients with ankle and leg fractures when they visit the Emergency Department. The main goal is to see how acceptable and effective this method is for temporarily stabilizing fractures that need to be manipulated (or adjusted) to heal properly. Researchers will look at how well the procedure works, how satisfied patients and doctors are with it, and whether there are any side effects within 48 hours after the procedure.

To participate in the trial, individuals must be over 18 years old and have a specific type of leg or ankle fracture that requires treatment in the Emergency Department. However, certain conditions, like open fractures or severe nerve problems, will exclude someone from joining the study. If eligible and willing to participate, patients can expect to receive the sciatic nerve block to help reduce their pain during the manipulation of their fracture, with close monitoring by the medical team throughout the process.

Gender

ALL

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