The Analgesic Effect of Pericapsular Nerve Group Block With Lateral Femoral Cutaneous Nerve Block and Pericapsular Nerve Group Block With Supra-inguinal Fascia Iliaca Block in Hip Hemiarthroplasty

A Comparative Study Between the Analgesic Effect of Pericapsular Nerve Group Block (PENG) With Lateral Femoral Cutaneous Nerve Block (LFCN) and Pericapsular Nerve Group Block (PENG) With Supra-inguinal Fascia Iliaca Block (SIFIC) in Hip Hemiarthroplasty: a Prospective Randomized Clinical Trial

The aim of this study is to investigate the efficiency of preoperative and post-operative analgesia by pericapsular nerve group block (PENG) block with supra-inguinal fascia iliaca block (SIFIC) block compared with PENG block with lateral femoral cutaneous nerve block (LFCN) block in ease of giving a sitting position for spinal anesthesia and reducing narcotic consumption during the first 24 hour post-operatively and functional recovary by using the Visual analogue scale (VAS) of pain.

Study Overview

• Status: Completed
• Conditions: Hip Hemiarthroplasty; Pericapsular Nerve Group Block; Lateral Femoral Cutaneous Nerve Block; Supra-inguinal Fascia Iliaca Block
• Intervention / Treatment: Other: Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC); Other: Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN)

Detailed Description

The established practice to decrease pain using opioids in hip fracture surgery may result in compromised outcomes in the frail and elderly population with nausea-vomiting, constipation, delirium and respiratory depression. This popularized the regional analgesic techniques in the surgical treatment of hip fractures. Femoral nerve (FN) and supra-inguinal fascia iliaca block (SIFIC) block are documented to provide good peri-operative analgesia with reduced need for opioids.

The latest pericapsular nerve group block (PENG) block, is an interfacial plane block targeting the articular branches of the femoral, obturator (ON) and accessory obturator nerves (AON) at the hip.

An ability to perform in supine positioning, which is especially important in patients with acute hip fractures or chronic pain is an indigenous advantage of PENG block. Due to the blockade of only sensory articular branches, substantial motor weakness is unexpected. But exclusive use of PENG block for analgesia in hip fracture patients is not sufficient as it doesn't involve the cutaneous pain-generating area supplied by the lateral femoral cutaneous nerve block (LFCN).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain Shams University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age 40-80 years.
• Sex: Both sexes.
• American Society of Anaesthesiologists (ASA) Physical Status Class I, II, and III.
• Scheduled for hip hemiarthroplasty under general anesthesia.

Exclusion Criteria:

• Declining to give a written informed consent.
• History of allergy to the medications used in the study.
• Contraindications to regional anesthesia (including patient refusal, coagulopathy and local infection).
• Psychiatric disorders or narcotic abusers.
• Significant cognitive dysfunction.
• American Society of Anesthesiologists (ASA) Physical Status Class IV.
• Renal insufficiency (to avoid local anesthetic or nalbuphine metabolites adverse effect)
• Opioid abuser patients
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC); Patients will receive pericapsular nerve group (PENG) block with supra-inguinal fascia iliaca (SIFIC) block.	Other: Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC); Patients will receive pericapsular nerve group (PENG) block with supra-inguinal fascia iliaca (SIFIC) block.
Experimental: Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN); Patients will receive pericapsular nerve group (PENG) block with lateral femoral cutaneous nerve (LFCN) block.	Other: Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN); Patients will receive pericapsular nerve group (PENG) block with lateral femoral cutaneous nerve (LFCN) block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of pain	Degree of pain will be assessed by visual analogue score (VAS). VAS ranging from 0 to 10, where 0 is no pain and 10 is maximum pain. It will be assessed preoperatively first after the block application then postoperatively, at post anesthesia care unit (PACU) and then 2, 6 ,12 ,18 ,24 hours postoperatively.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ease of giving a sitting position for spinal anesthesia (EOSP)	The ease of giving a sitting position for spinal anesthesia (EOSP) will be assessed by the EOSP score .EOSP was assessed on the scale of 0-3 (0 = unable to position, 1 = patient had abnormal posturing due to pain and required support for positioning, 2 = mild discomfort but does not require support for positioning, 3 = optimal condition where the patient was able to position himself	Intraoperatively
The total dose of nalbuphine consumption	When visual analogue score (VAS) >/=4, patients will receive injection nalbuphine 10 mg/70 kg (with maximum dose 160 mg over 24 hours) intravenously.	24 hours postoperatively
The number of patients who needed rescue analgesia	Number of patients who needed rescue analgesia will be recorded	24 hours postoperatively
Ablility to walk with support within 24 hours	The ability of patients to walk with support will be recorded	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: FMASU MD345/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No