Pericapsular Nerve Block in Proximal Femoral Fractures

NCT05840458 | Unknown DMC

• 1 other identifier: 48721715.0.0000.5461
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Fracture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Pain levels

  Before performing the PENG block

• Pain levels

  1 hour after performing the PENG block

• Pain levels

  12 hours after performing the PENG block

• Opioid consumption

  24 hours after performing the PENG Block

Study Arms (1)

PENG Block

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

Procedure: PENG Block

Interventions

PENG Block PROCEDURE

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.

PENG Block

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Study Sites (1)

Hospital Sírio-Libanês

São Paulo, São Paulo, Brazil

RECRUITING

Related 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.

  PMID: 30063657 BACKGROUND

• 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.

  PMID: 22150501 BACKGROUND

• 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.

  PMID: 33238043 BACKGROUND

• 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.

  PMID: 35186238 BACKGROUND

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Pedro P Kimachi, MD

CONTACT

+5511991752029; ppkimachi@yahoo.com.br

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 3, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 19, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)