- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07232173
Comparative Study Between Pericapsular Nerve Group Block (PENG) Versus Suprainguinal Fascia Iliaca Compartment Block (SIFIC) in Perioperative Hip Surgery
Comparative Study Between Pericapsular Nerve Group Block (PENG) Versus Suprainguinal Fascia Iliaca Compartment Block (SFIC) in Perioperative Hip Surgery
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt
- Faculty of Medicine, Ain Shams University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 40 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ultrasound-guided pericapsular nerve group block PENG
|
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.
|
|
Active Comparator: ultrasound-guided supra-inguinal fascia iliaca block SFIC
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
onset of analgesia
Time Frame: Assessed before the block and every 3 minutes from blocking for 30 minutes afterwards.
|
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 Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
NRS over 24 hours
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FMASU M D 235/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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