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

NCT06537323 | Recruiting

• 1 other identifier: Aswu 918/5/24
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Outcome Measures

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

  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,

  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

  At base line

Study Arms (3)

Femoral nerve block with0.25% bupivacaine

OTHER

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

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

PENG block with0.25% bupivacaine

OTHER

PENG block with0.25% bupivacaine guided by ultrasound

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

Preoperative IV fentanyl

OTHER

Preoperative IV fentanyl 100microgram

Drug: Preoperative IV fentanyl 100microgram

Interventions

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

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

Femoral nerve block with0.25% bupivacaine

PENG block with0.25% bupivacaine guided by ultrasound. DRUG

PENG block with0.25% bupivacaine guided by ultrasound.

PENG block with0.25% bupivacaine

Preoperative IV fentanyl 100microgram DRUG

Preoperative IV fentanyl 100microgram

Preoperative IV fentanyl

Eligibility Criteria

• Age: 55 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The included patient should be between 55 to 69 years

You may not qualify if:

• known allergies to local anesthetics

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Zaher

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

tarek sayed hemida, md

CONTACT

00201007363190; tarek.said@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 5, 2024
• Study Start: June 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: March 10, 2025
• Last Updated: March 13, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)