ClinicalTrials.gg
RecruitingNCT06537323Updated Mar 13, 2025

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

An interventional study of Femoral nerve block with0.25% bupivacaine guided by ultrasound. and PENG block with0.25% bupivacaine guided by ultrasound. in Postoperative Pain, sponsored by Aswan University Hospital. Recruiting at 1 site in Egypt. Open to participants aged 55 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Aswan University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
55 Years to 69 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Postoperative Pain

Browse trials for

03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 210 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Aswan University Hospital is the lead sponsor of 97 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The included patient should be between 55 to 69 years

Exclusion criteria

Exclusion Criteria:

  • known allergies to local anesthetics
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
210 participants (estimated)

Study arms

  • Other
    Femoral nerve block with0.25% bupivacaine

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

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

  • Other
    PENG block with0.25% bupivacaine

    PENG block with0.25% bupivacaine guided by ultrasound

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

  • Other
    Preoperative IV fentanyl

    Preoperative IV fentanyl 100microgram

    Drug: Preoperative IV fentanyl 100microgram

Interventions

  • DrugFemoral nerve block with0.25% bupivacaine guided by ultrasound.

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

  • DrugPENG block with0.25% bupivacaine guided by ultrasound.

    PENG block with0.25% bupivacaine guided by ultrasound.

  • DrugPreoperative IV fentanyl 100microgram

    Preoperative IV fentanyl 100microgram

06

What researchers measure

Primary outcomes

  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

    Time frame: before procedure, 24 hours and 30 days

Secondary outcomes

  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.

    Time frame: 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

    Time frame: At base line

07

Study locations

1 of 1 sites recruiting
  • Zaher
    Cairo, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06537323
Lead sponsor
Aswan University Hospital
Responsible party
Zaher Zaki Zaher (Lecturer, Aswan University Hospital) — Principal investigator
First posted
Aug 5, 2024
Start date
Jun 1, 2024
Primary completion
Nov 1, 2024
Completion
Mar 10, 2025 (estimated)
Last update
Mar 13, 2025

Study contacts

tarek sayed hemida, md
Contact
tarek.said@aswu.edu.eg
00201007363190

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion