Anterior Hip AnalgesiaFRONT blockNCT07268911
Femoral Rami Obturator Nerve Trunk (FRONT) Block in Intramedullary Nail Surgery .
A study testing Femoral rami obturator nerve trunk (FRONT) block in people with Anterior Hip Analgesia, run by South Valley University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Anterior Hip Analgesia
- What is being tested?
- Femoral rami obturator nerve trunk (FRONT) block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the elderly age≥60 years
- American Society of Anesthesiologists (ASA) classification I, II, III
- patients who undergoing surgery for intramedullary nail surgery.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anterior Hip Analgesia
- Being tested
- Femoral rami obturator nerve trunk (FRONT) block, Sham block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral rami obturator nerve trunk (FRONT) blockProcedure or surgery
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.
Sham blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 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) Receives: 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) Receives: Procedure: Sham block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first postoperative analgesic request
Description: Time in hours when the first patient request for rescue analgesia (IV nalbuphine 6 mg iv bolus)
Measured: [Time Frame: up to 36 hours postoperatively]
Secondary outcomes (5)
Opioid consumption
total opioid consumption will be recorded postoperatively
Measured: When 36 hours postoperatively has passed.
Complication
any complication either surgical or side effects will be recorded (vomiting, allergy, urinary retention, etc.)
Measured: 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)
Score from 0 = no pain at all to 10= worst pain imaginable, both at rest and movement
Measured: Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively]
Manual Muscle Testing (MRC scale)
Quadriceps strength graded manually against examiner resistance using the Medical Research Council (MRC) 0-5 scale, performed by the blinded outcome assessor.
Measured: Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively
Straight Leg Raise (SLR) test
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.
Measured: [Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Jan 2026
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Hip AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gaber Ahmed, South Valley University
- Investigators
- Zeinab M Sayed, MD, Study director, Qena University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268911
- Sponsor's protocol ID
- ِAIP029-4
- Acronym
- FRONT block
- Status last verified
- Aug 2026
- First submitted
- 25 Nov 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Rami Obturator Nerve Trunk (FRONT) Block in Intramedullary Nail Surgery .
- ClinicalTrials.gov ID
- NCT07268911
- Acronym / sponsor ID
- FRONT block / ِAIP029-4
- Conditions
- Anterior Hip Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FRONT Block | Experimental | Procedure: Femoral rami obturator nerve trunk (FRONT) blockFRONT 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) |
| Control group | Sham comparator | Procedure: Sham blockSham 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) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the elderly age≥60 years
- American Society of Anesthesiologists (ASA) classification I, II, III
- patients who undergoing surgery for intramedullary nail surgery.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral rami obturator nerve trunk (FRONT) blockultrasound-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. | Procedure or surgery | FRONT Block |
| Sham blockSham 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. | Procedure or surgery | Control group |
Primary outcome
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)
5 secondary outcomes
Opioid consumption
Time frame: When 36 hours postoperatively has passed.
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
Numeric Rating Scale (NRS)
Time frame: 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
Straight Leg Raise (SLR) test
Time frame: [Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeinab M Sayed, MD study director
Qena University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral rami obturator nerve trunk (FRONT) block in people with Anterior Hip Analgesia, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first postoperative analgesic request (time frame: [Time Frame: up to 36 hours postoperatively]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.