Femoral Rami Obturator Nerve Trunk (FRONT) Block in Intramedullary Nail Surgery .
FRONT block
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2025
CompletedFirst Submitted
Initial submission to the registry
November 25, 2025
CompletedFirst Posted
Study publicly available on registry
December 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedFebruary 19, 2026
February 1, 2026
6 months
November 25, 2025
February 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative analgesia
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 Outcomes (3)
Opioid consumption
When 36 hours postoperatively has passed.
Motor function
Patients will be followed for 36 hours postoperatively and assessed for motor function at 2, 4, 6, 12, 18, 24, 36 hours.
Complication
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
Study Arms (2)
FRONT Block
EXPERIMENTALParticipants (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).
Conventional Analgesia
ACTIVE COMPARATORParticipants (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).
Interventions
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.
Standard postoperative protocol: * IV nalbuphine (6 mg bolus PRN when NRS\>4 ) * IV paracetamol 1g every 6 hours * IV ketorolac 30 mg every 8 hours PRN (NRS \>4)
Eligibility Criteria
You may qualify if:
- the elderly age≥60 years
- American Society of Anesthesiologists (ASA) classification 1-2
- patients who undergoing surgery for intramedullary nail surgery.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qena University
Qina, Qena Governorate, 83511, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zeinab M Sayed, MD
Qena University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer in anesthesia, Intensive Care and Pain Management
Study Record Dates
First Submitted
November 25, 2025
First Posted
December 8, 2025
Study Start
November 1, 2025
Primary Completion
May 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share