Pericapsular Nerve Block in Proximal Femoral Fractures

Femoral Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05840458
• Other study ID #: 48721715.0.0000.5461
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Hospital Sirio-Libanes
• Contact: Pedro P Kimachi, MD
• Phone: +5511991752029
• Email: ppkimachi[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fracture
• Femoral Fractures
• Fractures, Bone

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Sírio-Libanês	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Opioid consumption	The total opioid consumption will be evaluated 24 hours after performing the PENG Block	24 hours after performing the PENG Block