Clinical trial NCT05840458: Pericapsular Nerve Block in Proximal Femoral Fractures
Official title: Effect of Systemic Analgesia and Systemic Analgesia Associated With Pericapsular Nerve Block in Proximal Femoral Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femoral Fracture
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unilateral proximal femoral fractures admitted to the emergency room.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional impairment
timeFrame: Before the intervention
measure: Functional impairment
timeFrame: 12 hours after intervention
Secondary outcomes:
measure: Pain levels
timeFrame: Before performing the PENG block
measure: Pain levels
timeFrame: 1 hour after performing the PENG block
measure: Pain levels
timeFrame: 12 hours after performing the PENG block
measure: Opioid consumption
timeFrame: 24 hours after performing the PENG Block
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Sírio-Libanês
state: Sao Paulo
Study officials:
References:
citation: 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.
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.
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.
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.