the Pericapsular Nerve Group (PENG) and Suprainguinal Fascia Iliaca Blocks (SIFIB) in Elderly Patients

NCT06277648 | Completed

• 1 other identifier: 18-2021
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to compare the effect of the pericapsular nerve group (PENG) and suprainguinal fascia iliaca blocks (SIFIB) on pain management in elderly patients with subtrochanteric femur fractures. The participants will be patients determined to have proximal femoral nailing. According to randomisation, each participant will receive either PENG or SIFIB postoperatively after spinal anaesthesia. The investigator will measure postoperative pain scores, total amount of analgesic consumption and motor ability postoperatively.

Conditions

Collum Femoris Fracture; Pericapsular Nerve Group Block; Suprainguinal Fascia Iliaca Block

Keywords

femur fracture; suprainguinal fascia iliaca block; pericapsular nerve group block; elderly patients; postoperative pain

Outcome Measures

Primary Outcomes (1)

• pain scores

  the numeric rating scale (which ranges from 0 to 10, where zero represents the absence of pain, and 10 signifies the worst imaginable pain)

  postoperative 24 hour

Secondary Outcomes (1)

• rescue analgesia

  postoperative 24 hour

Study Arms (3)

Control

NO INTERVENTION

All patients received standard spinal anaesthesia procedures with multimodal pain protocol postoperatively.

PENG block

EXPERIMENTAL

All patients received standard spinal anaesthesia procedures with PENG block postoperatively.

Procedure: PENG block

SIFI block

EXPERIMENTAL

All patients received standard spinal anaesthesia procedures with SIFIB postoperatively.

Procedure: SIFIB

Interventions

PENG block PROCEDURE

PENG block was performed by the primary investigator (B.C) following proper skin disinfection with the patient in the supine position. Under the guidance of a low-frequency curvilinear ultrasound probe, the iliopubic eminence and the psoas tendon were identified, and local anaesthetic as 30 mL 0.375% bupivacaine was injected between the periosteum and psoas tendon following negative aspiration.

Also known as: pericapsuşar nerve group block

PENG block

SIFIB PROCEDURE

The high-frequency linear probe was placed medial to the anterosuperior iliac spine in a parasagittal orientation to visualize the bow tie appearance formed by the sartorius's internal oblique and iliacus muscles. The needle tip was placed under fascia iliaca through an in-plane approach, and local anaesthetic as 30 mL 0.375% bupivacaine was injected from the caudad to the cephalic direction.

Also known as: suprainguinal fascia iliaca block

SIFI block

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 65
• Patients scheduled for proximal femoral nailing
• Patients with American Society of Anesthesiologists (ASA) Physical Status classification of I to IV.

You may not qualify if:

• refusal to participate
• a history of neurological deficits or neuropathy
• infection at the site of block application
• coagulopathy
• allergy to local anaesthetics
• patients with severe cardiopulmonary insufficiency or renal impairment
• mental illness.
• prolonged surgery due to orthopaedic complications of more than 3 hours, necessitating conversion of spinal anaesthesia to general anaesthesia.

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, Turkey (Türkiye)

Location

Related Publications (2)

• Vamshi C, Sinha C, Kumar A, Kumar A, Kumari P, Kumar A, Kumar S, Arun SK. Comparison of the efficacy of pericapsular nerve group block (PENG) block versus suprainguinal fascia iliaca block (SFIB) in total hip arthroplasty: A randomized control trial. Indian J Anaesth. 2023 Apr;67(4):364-369. doi: 10.4103/ija.ija_311_22. Epub 2023 Apr 10.

  PMID: 37303868 BACKGROUND

• Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.

  PMID: 34290085 BACKGROUND

MeSH Terms

Conditions

Femoral Fractures; Pain, Postoperative

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Berna Caliskan

  Haseki Training and Research Hospital Anesthesiology and Reanimation Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The orthopaedic surgeon responsible for the study was blinded to the study groups. This surgeon was the sole evaluator of postoperative pain scores and total analgesia consumption.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a double-blind, prospective, randomized, controlled study

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: January 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 15, 2024
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)