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.
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.
Egypt1 site, 1 recruiting
- Recruiting
Zaher
Cairo
mostafa tairy adam, md, 00201092991101, vdr@med.aswu.edu.eg
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.
- Conditions
- Postoperative Pain
- 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 group | Role | What they receive |
|---|---|---|
| Femoral nerve block with0.25% bupivacaine | Other | Femoral nerve block with0.25% bupivacaine guided by ultrasound. Receives: Drug: Femoral nerve block with0.25% bupivacaine guided by ultrasound. |
| PENG block with0.25% bupivacaine | Other | PENG block with0.25% bupivacaine guided by ultrasound Receives: Drug: PENG block with0.25% bupivacaine guided by ultrasound. |
| Preoperative IV fentanyl | Other | Preoperative 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.
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)
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
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.
- First posted5 Aug 2024
- Study start1 Jun 2024
- Primary completion1 Nov 2024
- Study completion10 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaher Zaki Zaher, Aswan University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06537323
- Acronym / sponsor ID
- Aswu 918/5/24
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 10 Mar 2025 (estimated)
- First posted
- 5 Aug 2024 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Femoral nerve block with0.25% bupivacaine | Other | Drug: Femoral nerve block with0.25% bupivacaine guided by ultrasound.Femoral nerve block with0.25% bupivacaine guided by ultrasound. |
| PENG block with0.25% bupivacaine | Other | Drug: PENG block with0.25% bupivacaine guided by ultrasound.PENG block with0.25% bupivacaine guided by ultrasound |
| Preoperative IV fentanyl | Other | Drug: Preoperative IV fentanyl 100microgramPreoperative IV fentanyl 100microgram |
Who may qualify
- Ages
- 55 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The included patient should be between 55 to 69 years
Key exclusion criteria (1 listed)
- known allergies to local anesthetics
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 nerve block with0.25% bupivacaine guided by ultrasound.Femoral nerve block with0.25% bupivacaine guided by ultrasound. | Drug | Femoral nerve block with0.25% bupivacaine |
| PENG block with0.25% bupivacaine guided by ultrasound.PENG block with0.25% bupivacaine guided by ultrasound. | Drug | PENG block with0.25% bupivacaine |
| Preoperative IV fentanyl 100microgramPreoperative IV fentanyl 100microgram | Drug | Preoperative IV fentanyl |
Primary outcome
EOSA score (Ease of Spinal Anesthesia) Score
Time frame: before procedure, 24 hours and 30 days
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
2 secondary outcomes
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,
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
BMI
Time frame: At base line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- 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.
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 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.