NCT07268911

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

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress89%
Nov 2025Jun 2026

Study Start

First participant enrolled

November 1, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

November 25, 2025

Last Update Submit

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

EXPERIMENTAL

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).

Procedure: Femoral rami obturator nerve trunk (FRONT) block

Conventional Analgesia

ACTIVE COMPARATOR

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).

Drug: Multimodal systemic analgesia

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.

FRONT Block

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)

Conventional Analgesia

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Zeinab M Sayed, MD

    Qena University

    STUDY DIRECTOR

Central Study Contacts

Zeinab M Sayed, MD

CONTACT

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

Locations