- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07268911
Femoral Rami Obturator Nerve Trunk (FRONT) Block in Intramedullary Nail Surgery . (FRONT block)
February 17, 2026 updated by: Mohamed Gaber Ahmed, South Valley University
The study propose that using femoral rami obturator nerve trunk(FRONT) block may help postoperative analgesia in nail femur surgeries.
The technique is relatively new, introducing one needle to target two nerve blocks in the same entry point.
The block spare motor fibers of femoral nerve so it may help both early mobilization and effective analgesia, which in turn enhance early recovery and better outcomes.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Post operative pain levels after hip fracture are high during ambulation and may worsen outcome after hip fracture.
Regional anesthesia has shown to facilitate rehabilitation in orthopedics procedures.
Many of these regional anesthesia techniques ,such as femoral nerve, lumber plexus, peri capsular nerve group(PENG), fascia iliaca blocks have gained attention for their opioid and some times for motor sparing potential, as well as the ability to provide targeted analgesia for anterior hip joint.
Nevertheless the anterior hip joint coverage needs the constant contribution of femoral and obturator nerves to provide adequate pain relieve.
In this study patients will receive preoperative femoral rami obturator nerve trunk(FRONT) block , a novel regional anesthesia technique described by Jessen et al., as a promising solution to the long-standing challenge of anesthetizing both the femoral and obturator nerve branches in anterior hip joint for postoperative pain control, addressing a more comprehensive coverage of anterior hip innervation.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zeinab M Sayed, MD
- Phone Number: +02 01009071365
- Email: zeinab5aton@gmail.com
Study Locations
-
-
Qena Governorate
-
Qina, Qena Governorate, Egypt, 83511
- Recruiting
- Qena University
-
Contact:
- ZAINAB MOSTAFA
- Phone Number: 002- 0100-9071365
- Email: zeinab5aton@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- the elderly age≥60 years
- American Society of Anesthesiologists (ASA) classification 1-2
- patients who undergoing surgery for intramedullary nail surgery.
Exclusion Criteria:
- patient refused to participate and consent
- patients with a history of mild cognitive impairment (MCI), dementia, and delirium
- patients with known preoperative infections (pulmonary infection, urinary infection, and sepsis).
- coagulopathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FRONT Block
Participants (n=42) will receive Ultrasound-guided FRONT block.
n=42 patients.
Powered at 90% to detect 1-point NRS superiority (SD 1.8, alpha 0.05).
|
ultrasound-guided FRONT block will be performed at the infrainguinal level, targeting the iliopsoas plane.
Using the same needle approach, the subpectineal compartment will be also accessed .
We will use ultrasound and electrical nerve stimulation guidance (0.4 mA, 0.1 ms, without eliciting a motor response) to avoid direct involvement of the femoral nerve.
A total of 40 mL (20 mL for the iliopsoas plane and 20 mL for the subpectineal compartment) of 0.125% plain levobupivacaine will be administered.
|
|
Active Comparator: Conventional Analgesia
Participants (n=42) patients will be assigned to intervention multimodal systemic analgesia.
n=42 patients.
Powered at 90% to detect 1-point NRS superiority (SD 1.8, alpha 0.05).
|
Standard postoperative protocol:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative analgesia
Time Frame: Patients will be followed for 36 hours postspinal and assessed for pain, at 2, 4, 6, 12, 18, 24, 36 hours
|
Pain level will be assessed after spinal anesthesia is resolved using rest/dynamic numeric rating scale (NRS) with patients rating their pain on a scale from 0 to 10.
On this scale, 0 means "no pain" and 10 means "the worst pain imaginable"
|
Patients will be followed for 36 hours postspinal and assessed for pain, at 2, 4, 6, 12, 18, 24, 36 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid consumption
Time Frame: When 36 hours postoperatively has passed.
|
First analgesic request time and total opioid consumption will be recorded
|
When 36 hours postoperatively has passed.
|
|
Motor function
Time Frame: Patients will be followed for 36 hours postoperatively and assessed for motor function at 2, 4, 6, 12, 18, 24, 36 hours.
|
Motor function will be assessed using Modified Bromage scale after spinal anesthesia has been resolved, where score 0 means full movement, and 4 means complete motor loss.
|
Patients will be followed for 36 hours postoperatively and assessed for motor function at 2, 4, 6, 12, 18, 24, 36 hours.
|
|
Complication
Time Frame: Patients will be followed for 36 hours postoperatively and assessed for presence of any complications or side effects at 2, 4, 6, 12, 18, 24, 36 hours
|
any complication either surgical or side effects will be recorded (vomiting, allergy, urinary retention, etc.)
|
Patients will be followed for 36 hours postoperatively and assessed for presence of any complications or side effects at 2, 4, 6, 12, 18, 24, 36 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Zeinab M Sayed, MD, Qena University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2025
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
November 25, 2025
First Submitted That Met QC Criteria
November 25, 2025
First Posted (Actual)
December 8, 2025
Study Record Updates
Last Update Posted (Actual)
February 19, 2026
Last Update Submitted That Met QC Criteria
February 17, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ِAIP029-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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