NCT07232173

Brief Summary

The hip joint is the largest and one of the most stable joints in the human body. It bears the majority of the body's weight during both dynamic and static activities, making it highly susceptible to degenerative diseases, particularly in the elderly population. In advanced cases, total hip arthroplasty (THA) is often required-currently ranking as the second most common joint replacement procedure worldwide. Despite its clinical success, it is estimated that 7-28% of patients experience chronic postoperative pain following THA. This persistent pain significantly impairs quality of life and is receiving growing attention from healthcare professionals. Evidence suggests that unmanaged acute surgical pain is a major risk factor for the development of chronic postoperative pain, underscoring the importance of effective perioperative analgesia. Given the adverse effects associated with opioids, regional anesthesia techniques are increasingly favored for pain management. Among these, the fascia iliaca compartment block (FICB) has been widely used to reduce postoperative pain intensity, although it carries potential drawbacks such as motor weakness or a need for supplemental opioid use. Recent anatomical studies by Short et al. have identified the anterior capsule of the hip joint as being innervated by the pericapsular nerve group (PNG) including the obturator nerve, accessory obturator nerve, and femoral nerve. The anatomical accessibility of these nerves has enabled the development of the pericapsular nerve group (PENG) block, a motor-sparing regional anesthesia technique that offers targeted analgesia by delivering local anesthetics into the myofascial plane between the psoas muscle and the superior pubic ramus. While both FICB and PENG blocks are widely used in total hip replacement surgeries, comparative evidence evaluating their efficacy remains limited. Therefore, this study aims to compare the analgesic effectiveness of FICB and PENG blocks during the preoperative and postoperative phases of total hip arthroplasty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
Last Updated

November 18, 2025

Status Verified

October 1, 2025

Enrollment Period

8 months

First QC Date

November 14, 2025

Last Update Submit

November 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • onset of analgesia

    defined as an NRS of 3 or less at rest and during passive 20° limb elevation.

    Assessed before the block and every 3 minutes from blocking for 30 minutes afterwards.

Secondary Outcomes (1)

  • NRS over 24 hours

    24 hours

Study Arms (2)

ultrasound-guided pericapsular nerve group block PENG

ACTIVE COMPARATOR
Procedure: Pericapsular Nerve Group Block (PENG)

ultrasound-guided supra-inguinal fascia iliaca block SFIC

ACTIVE COMPARATOR
Procedure: Suprainguinal Fascia Iliaca compartment Block (SIFIC)

Interventions

Participants in the PENG group first received their study medication, administered over a 1-minute interval, 5 minutes prior to the initiation of spinal anesthesia. For the block itself, an in-plane ultrasound-guided approach was utilized. Following the creation of a skin wheal, an echogenic, 10-centimeter, 21-gauge needle was carefully advanced in a lateral-to-medial trajectory. The local anesthetic, 20 mL of .5% ropivacaine, was then accurately injected into the fascial plane located anterior to the psoas tendon and posterior to the pubic ramus.

ultrasound-guided pericapsular nerve group block PENG

The SFIC group block began with a skin wheal and employed an in-plane needle insertion. Once the needle successfully pierced the fascia iliaca, a small 2 mL volume of saline was initially injected. This served as a hydraulic confirmation of the correct needle tip placement within the compartment.

ultrasound-guided supra-inguinal fascia iliaca block SFIC

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • non-pathologic hip fractures
  • underwent total hip arthroplasty (THA) or hemiarthroplasty at Ain Shams University Hospitals
  • physical status I, II and III according to the American Society of Anesthesiologists (ASA) classification.

You may not qualify if:

  • pathological fracture
  • allergy to study drugs.
  • ASA IV (a patient with severe systemic disease that is a constant threat to life)
  • bleeding tendencies
  • dementia or any mental disability
  • having sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

January 1, 2023

Primary Completion

September 1, 2023

Study Completion

December 1, 2023

Last Updated

November 18, 2025

Record last verified: 2025-10

Locations