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

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

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
24 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

August 4, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

November 25, 2025

Last Update Submit

August 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to first postoperative analgesic request

    Description: Time in hours when the first patient request for rescue analgesia (IV nalbuphine 6 mg iv bolus)

    [Time Frame: up to 36 hours postoperatively]

Secondary Outcomes (5)

  • Opioid consumption

    When 36 hours postoperatively has passed.

  • 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

  • Numeric Rating Scale (NRS)

    Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively]

  • Manual Muscle Testing (MRC scale)

    Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively

  • Straight Leg Raise (SLR) test

    [Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively]

Study Arms (2)

FRONT Block

EXPERIMENTAL

FRONT Block: Patients received an ultrasound-guided femoral rami and obturator nerve trunk (FRONT) block, performed in the operating room prior to spinal anesthesia with the patient supine. Using an in-plane technique with a 22-gauge echogenic needle through a single entry point, 20 mL of 0.125% plain levobupivacaine was deposited in the iliopsoas plane and 20 mL in the subpectineal compartment. Electrical nerve stimulation (0.4 mA, 0.1 ms pulse duration) was used to confirm needle placement and exclude direct femoral motor nerve involvement prior to injection. Sensory block was confirmed via pinprick before proceeding to spinal anesthesia. All patients, including the FRONT group, received the same standardized multimodal systemic analgesic regimen (paracetamol 1g/6h and ketorolac 30 mg /8h routinely plus nalbuphine 6 mg IV bolus as rescue analgesia when needed for NRS ≥ 4)

Procedure: Femoral rami obturator nerve trunk (FRONT) block

Control group

SHAM COMPARATOR

Sham Control: Patients underwent an identical ultrasound-guided needle insertion procedure at the same anatomical sites (iliopsoas plane and subpectineal compartment) with injection of an equivalent volume of placebo drug in the form of normal salin. All patients, including the sham group, received the same standardized multimodal systemic analgesic regimen (paracetamol 1g/6h and ketorolac 30 mg /8h routinely plus nalbuphine 6 mg IV bolus as rescue analgesia when needed for NRS ≥ 4)

Procedure: Sham block

Interventions

Sham blockPROCEDURE

Sham Control: Patients underwent an identical ultrasound-guided needle insertion procedure at the same anatomical sites and technique of FRONT block (iliopsoas plane and subpectineal compartment) with injection of an equivalent volume of placebo drug in the form of normal saline.

Control group

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

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

Location

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, 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

January 1, 2026

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

August 4, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations