AzTrials
AzTrials

Postoperative PainNCT06537323

Femoral Nerve Block, Periarticular Nerve Group (PENG) Block, and Preoperative IV Fentanyl

A study testing Femoral nerve block with0.25% bupivacaine guided by ultrasound., PENG block with0.25% bupivacaine guided by ultrasound. and Preoperative IV fentanyl 100microgram in people with Postoperative Pain, run by Aswan University Hospital at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The pericapsular nerve group block is a regional anesthetic technique described in 2018, developed primarily in total hip arthroplasties for postoperative analgesia with motor sparing benefits. Read more about this study

Who is it for?
Ages 55 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Pain
What is being tested?
Femoral nerve block with0.25% bupivacaine guided by ultrasound., PENG block with0.25% bupivacaine guided by ultrasound. and Preoperative IV fentanyl 100microgram
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteEgypt
Study dates
1 Jun 2024to 10 Mar 2025
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 55 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The included patient should be between 55 to 69 years

Who cannot join

  • known allergies to local anesthetics

Trial locations and contacts

1 site in 1 country.

tarek sayed hemida, md contact

00201007363190

tarek.said@aswu.edu.eg

Egypt1 site, 1 recruiting
  • Zaher

    Cairo

    mostafa tairy adam, md, 00201092991101, vdr@med.aswu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Comparative Analysis of Educational Interventions and Anesthetic Techniques for Enhanced Spinal Anesthesia Quality in Fractured Neck of Femur: Femoral Nerve Block, Periarticular Nerve Group (PENG) Block, and Preoperative IV Fentanyl

The pericapsular nerve group block is a regional anesthetic technique described in 2018, developed primarily in total hip arthroplasties for postoperative analgesia with motor sparing benefits. The block is thought to provide more complete analgesia to the hip by depositing local anesthetic within the myofascial plane of the psoas muscle and superior pubic ramus. The indications for total hip arthroplasties often include degenerative hip disease and traumatic hip fractures. These indications for surgery are relatively common in the elderly population and are associated with significant morbidity and mortality.

Read the detailed description

The pericapsular nerve block is a regional anesthetic technique described in 2018, developed primarily in total hip arthroplasties for postoperative analgesia with motor sparing benefits. The block is thought to provide more complete analgesia to the hip by depositing local anesthetic within the myofascial plane of the psoas muscle and superior pubic ramus.The indications for total hip arthroplasties often include degenerative hip disease and traumatic hip fractures. These indications for surgery are relatively common in the elderly population and are associated with significant morbidity and mortality.Operative intervention, such as total hip arthroplasties has also been associated with significant pain. Historically, the most commonly performed peripheral nerve blocks include lumbar plexus block, a femoral nerve block, or a fascia iliaca compartment block to manage post-operative analgesia. With the understanding that additional articular branches these blocks will provide incomplete analgesia to the hip and may also predispose the patient to fall due to weakness of the quadriceps muscles.Therefore the ideal block technique should provide complete analgesia of the hip joint and without muscle weakness. The ultrasound-guided pericapsular nerve block block allows for coverage of the hip joint, targeting the proximal articular branches that innervate the joint capsule. This proximal approach via ultrasound guidance can confer several advantages over a femoral nerve block by providing more complete analgesia to the hip joint. Additionally, the motor function of the involved extremity should be spared. The pericapsular nerve block block can be used alone as a primary analgesic or in conjunction with other forms of anesthesia during surgery or in the perioperative period. For lateral surgical incisions, a supplemental lateral femoral cutaneous nerve block provides additional coverage.The femoral nerve is among the largest branches of the lumbar plexus. The femoral nerve arises from the ventral rami of the Lumeber 2, Lumber 3, and Lumber 4 spinal nerves, and enters the femoral triangle inferior to the inguinal ligament. The femoral nerve is the most lateral of the structures within the triangle, which also contains the femoral artery and femoral vein at its medial end. The femoral nerve splits into anterior and posterior divisions that originate near the level of the circumflex artery. The anterior division gives rise to the medial femoral cutaneous nerve and innervates the sartorius muscle. The posterior division gives rise to the saphenous nerve and provides innervation to quadriceps femoris muscle. In addition to motor innervation, the femoral nerve provides sensation to the anterior thigh and knee and the medial lower extremity below the knee. The saphenous nerve is a femoral nerve branch that is directly responsible for sensation to the medial lower leg and foot. The saphenous nerve can be blocked separately at the level of the adductor canal, and several more distal sites. The adductor canal is a musculoaponeurotic tunnel found in the mid-thigh and extends from the femoral triangle to the adductor magnus.Due to the anatomical connection, the femoral nerve within the femoral triage may potentially be affected by proximal or high-volume adductor canal blocks.

Being tested
Femoral nerve block with0.25% bupivacaine guided by ultrasound., PENG block with0.25% bupivacaine guided by ultrasound., Preoperative IV fentanyl 100microgram
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Femoral nerve block with0.25% bupivacaine guided by ultrasound.Drug

    Femoral nerve block with0.25% bupivacaine guided by ultrasound.

  • PENG block with0.25% bupivacaine guided by ultrasound.Drug

    PENG block with0.25% bupivacaine guided by ultrasound.

  • Preoperative IV fentanyl 100microgramDrug

    Preoperative IV fentanyl 100microgram

Study groups in NCT06537323
Study groupRoleWhat they receive
Femoral nerve block with0.25% bupivacaineOtherFemoral nerve block with0.25% bupivacaine guided by ultrasound.
Receives: Drug: Femoral nerve block with0.25% bupivacaine guided by ultrasound.
PENG block with0.25% bupivacaineOtherPENG block with0.25% bupivacaine guided by ultrasound
Receives: Drug: PENG block with0.25% bupivacaine guided by ultrasound.
Preoperative IV fentanylOtherPreoperative IV fentanyl 100microgram
Receives: Drug: Preoperative IV fentanyl 100microgram

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EOSA score (Ease of Spinal Anesthesia) Score

    Ease of Spinal Anesthesia (EOSA) Score The Ease of Spinal Anesthesia (EOSA) score is a structured tool used to evaluate the technical ease and patient cooperation during spinal anesthesia administration. It incorporates multiple factors that influence the success and efficiency of the procedure.

    Components of the EOSA Score:

    The score assesses the following five key factors:

    Patient positioning time - The time required to achieve an optimal position for spinal anesthesia.

    Patient cooperation - The level of patient compliance and ability to maintain the required position.

    Technical difficulty - The ease of needle insertion, including the number of attempts required.

    Need for additional assistance - Whether repositioning, sedation, or extra staff intervention was required.

    Anesthesiologist's overall ease rating - The subjective assessment of how smoothly the procedure was performed.

    Each factor is assigned a score, with higher EOSA scores indicating greater ease of spinal anesthesia a

    Measured: before procedure, 24 hours and 30 days

Secondary outcomes (2)
  1. time to the first request for analgesia, nalbuphine consumption within the first 24 hours, postoperative pain scores, intraoperative hemodynamic stability, duration of the spinal block, patient satisfaction, the incidence of complications,

    Hemodynamic parameters, including mean arterial blood pressure (MAP) and heart rate (HR), were recorded at baseline, and subsequently at 30, 60, 90, and 120 minutes, as well as at the end of surgery.

    Pain was evaluated using VAS at 1, 6, 12, and 24 hours postoperatively. The total amount of nalbuphine used during the first 24 hours. If the VAS score exceeded 4, 0.1 mg/kg nalbuphine was administered. The time to first rescue analgesia was measured from the end of surgery to the initial request for additional pain relief.

    Complications, including hypotension, nausea, vomiting, respiratory depression, pruritus, urinary retention, motor weakness, local anesthetic systemic toxicity, and block-related side effects, were meticulously documented. Hypotension, a reduction in baseline means arterial pressure by 20% or an absolute value below 65 mmHg, was managed with 10 mg of ephedrine. Postoperative nausea and vomiting (PONV) were treated with intravenous ondansetron at a dose of 0.1 mg/kg.

    Measured: before procedure, 24 hours and 30 days,VAS at 1, 6, 12, and 24 hours postoperatively.-Hemodynamic parameters, including mean arterial blood pressure (MAP) and heart rate (HR), were recorded at baseline, and subsequently at 30, 60, 90, and 120 minutes, as

  2. BMI

    Weight in Kg /(height in meter *height in meter)

    =kg/m2

    Measured: At base line

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2024
  2. Study start1 Jun 2024
  3. Primary completion1 Nov 2024
  4. Study completion10 Mar 2025 (estimated)

Resources

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
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06537323
Sponsor's protocol ID
Aswu 918/5/24
Status last verified
Aug 2024
First submitted
25 Jul 2024
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Femoral nerve block with0.25% bupivacaine guided by ultrasound., PENG block with0.25% bupivacaine guided by ultrasound. and Preoperative IV fentanyl 100microgram in people with Postoperative Pain, run by Aswan University Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 2025. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact tarek sayed hemida, md (00201007363190, tarek.said@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EOSA score (Ease of Spinal Anesthesia) Score (time frame: before procedure, 24 hours and 30 days). 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 13 Mar 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in