Pericapsular Nerve Block in Proximal Femoral Fractures

Recruiting

• Conditions: Femoral Fracture
• Interventions: Procedure: PENG Block

• Registration Number: NCT05840458
• Lead Sponsor: Hospital Sirio-Libanes

Brief Summary

Proximal femoral fractures commonly occur above 50 years and regional anesthesia could be a complement in the perioperative treatment of the patients. The use of pericapsular nerve group block (PENG Block) has been proposed to reduce pain. However, no studies have explored the efficient of the systemic analgesia associated with PENG Block in functional limitation in the preoperative period. In this sense, the main goal of this study is to evaluate the effectiveness of systemic analgesia associated with PENG Block in patients with proximal femoral fractures in the period preceding the surgical procedure.

Detailed Description

Focus on functional capacity will be measured by the Activity Measure for Post-Acute Care (AM-PAC) short version of the "6 Clicks", pain intensity will be assessed using the numerical rating scale, and opioid consumption. This study will include 21 patients admitted to the Emergency Room with proximal femoral fractures.

Study Timeline

• Status Verified: 2023-04
• Study Start: 2023-04-01
• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-22
• Study First Posted: 2023-05-03
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• patients with unilateral proximal femoral fractures admitted to the emergency room of the Hospital Sírio-Libanes,
• aged 18-105 years
• with the American Society of Anesthesiology (ASA) physical status I, II, or III.

Exclusion Criteria

• allergy to metamizole and/or ropivacaine
• history of mental disorders
• presence of chronic pain as assessed using the Douleur Neuropathique 4 (DN4) questionnaire

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PENG Block	PENG Block	Patients will be submitted to PENG block intervention guiding by ultrasound.

Primary Outcome Measures

Name	Time	Method
Functional impairment	12 hours after intervention	The Short-form of Activity Measure for Post-Acute Care (AM-PAC- "6 clicks") is a measure of basic patient mobility will be used. Higher scores mean better outcomes. Minimum 6 points, maximum 26 points.

Secondary Outcome Measures

Name	Time	Method
Pain levels	12 hours after performing the PENG block	The Numeric Rating Scale will be used to evaluate pain levels. Higher scores mean worst. outcomes. Minimum 0 point, maximum 10 points.
Opioid consumption	24 hours after performing the PENG Block	The total opioid consumption will be evaluated 24 hours after performing the PENG Block

Trial Locations

Locations (1)

Hospital Sírio-Libanês; 🇧🇷 São Paulo, Sao Paulo, Brazil