Pericapsular Nerve Block in Proximal Femoral Fractures

Effect of Systemic Analgesia and Systemic Analgesia Associated With Pericapsular Nerve Block in Proximal Femoral Fractures

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.

Study Overview

• Status: Recruiting
• Conditions: Femoral Fracture
• Intervention / Treatment: Procedure: PENG Block

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 Type: Observational
• Enrollment (Estimated): 21

Contacts and Locations

• Study Contact: Name: Pedro P Kimachi, MD; Phone Number: +5511991752029; Email: ppkimachi@yahoo.com.br

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil
      • Recruiting
      • Hospital Sírio-Libanês
      • Contact: Pedro P Kimachi, MD; Phone Number: +5511991752029; Email: ppkimachi@yahoo.com.br

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with unilateral proximal femoral fractures admitted to the emergency room.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

PENG Block; Patients will be submitted to PENG block intervention guiding by ultrasound.

Procedure: PENG Block; Patient will be placed in the supine position and the ultrasound probe will be placed in the transverse plane over the anterior inferior iliac spine (AIIS) and aligned with the pubic ramus by rotating the probe counterclockwise by approximately 45 degrees. A 22-gauge, 100 mm needle will be inserted using the plane approach from lateral to medial, between the psoas tendon anteriorly and the pubic ramus posteriorly. Following a negative aspiration, 20 mL of 0.375% ropivacaine will be injected. The needle position will be confirmed by visualizing the separation of layers with the dispersion of the injected volume.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional impairment	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.	Before the intervention
Functional impairment	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.	12 hours after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain levels	The Numeric Rating Scale will be used to evaluate pain levels. Higher scores mean worst. outcomes. Minimum 0 point, maximum 10 points.	Before performing the PENG block
Pain levels	The Numeric Rating Scale will be used to evaluate pain levels. Higher scores mean worst. outcomes. Minimum 0 point, maximum 10 points.	1 hour after performing the PENG block
Pain levels	The Numeric Rating Scale will be used to evaluate pain levels. Higher scores mean worst. outcomes. Minimum 0 point, maximum 10 points.	12 hours after performing the PENG block
Opioid consumption	The total opioid consumption will be evaluated 24 hours after performing the PENG Block	24 hours after performing the PENG Block

Collaborators and Investigators

• Sponsor: Hospital Sirio-Libanes

Publications and helpful links

General Publications

• Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
• Membership of the Working Party; Griffiths R, Alper J, Beckingsale A, Goldhill D, Heyburn G, Holloway J, Leaper E, Parker M, Ridgway S, White S, Wiese M, Wilson I. Management of proximal femoral fractures 2011: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2012 Jan;67(1):85-98. doi: 10.1111/j.1365-2044.2011.06957.x.
• Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
• Hua H, Xu Y, Jiang M, Dai X. Evaluation of Pericapsular Nerve Group (PENG) Block for Analgesic Effect in Elderly Patients with Femoral Neck Fracture Undergoing Hip Arthroplasty. J Healthc Eng. 2022 Feb 9;2022:7452716. doi: 10.1155/2022/7452716. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 22, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: 48721715.0.0000.5461

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