Femoral Rami Obturator Nerve Trunk (FRONT) Block in Intramedullary Nail Surgery . (FRONT block)

August 16, 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

Completed

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.

Note: The protocol was amended prior to enrollment of the reported cohort. The control group was changed from multimodal analgesia alone to a sham block procedure; the primary outcome was changed from postoperative NRS pain score to time to first analgesic request; motor assessment was changed from the Modified Bromage scale to Manual Muscle Testing (MRC scale) and straight leg raise, the Modified Bromage scale being discontinued; and the upper limit of ASA physical status was extended from II to III.

Study Type

Interventional

Enrollment (Actual)

110

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 Locations

  • Egypt
    • Qena Governorate
      • Qina, Qena Governorate, Egypt, 83511
        • Qena University

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 I, II, III
  • 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control group
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
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.
Experimental: FRONT Block
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 checked by pinprick before proceeding to spinal anesthesia as routine clinical practice; these findings were not systematically recorded. 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first postoperative analgesic request
Time Frame: [Time Frame: up to 36 hours postoperatively]
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Numeric Rating Scale (NRS)
Time Frame: Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively]
Score from 0 = no pain at all to 10= worst pain imaginable, both at rest and movement
Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively]
Manual Muscle Testing (MRC scale)
Time Frame: Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively
Quadriceps strength graded manually against examiner resistance using the Medical Research Council (MRC) 0-5 scale, performed by the blinded outcome assessor.
Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively
Straight Leg Raise (SLR) test
Time Frame: [Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively]
Description: Ability to actively raise the extended leg off the bed, assessed as a functional indicator of quadriceps/hip flexor motor recovery, performed by the blinded outcome assessor.
[Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively]
Opioid consumption
Time Frame: When 36 hours postoperatively has passed.
total opioid consumption will be recorded postoperatively
When 36 hours postoperatively has passed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

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)

January 1, 2026

Primary Completion (Actual)

June 1, 2026

Study Completion (Actual)

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)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 16, 2026

Last Verified

August 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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