Which Analgesia is Better for Proximal Femoral Fractures?

NCT ID: NCT04309539

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2022-03-31

Brief Summary

This patient population is typically elderly and frail. They are at risk of adverse effects secondary to inadequate pain management such as prolonged admissions and poor functional outcomes.

Regional analgesia is preferred due to their opioid-sparing effects and reduction in related adverse effects but The analgesia from these blocks is only moderate and literature suggests that the obturator nerve (ON) is not covered.

Detailed Description

The aim of this study is to compare the effect of combined lateral femoral cutaneous nerve block with pericapsular nerve group block versus fascia iliaca block for proximal femur surgery.

Fascia iliaca compartment block is a simple technique to manage pain before positioning for spinal anesthesia performance and it constitutes a practical choice for perioperative pain control.

A recent anatomical study confirmed the innervation of the anterior hip by these 3 main nerves, but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported The high articular branches from FN and AON are consistently found between the anterior inferior iliac spine (AIIS) and the iliopubic eminence (IPE), whereas the ON is located close to the inferomedial acetabulum.

The ultrasound-guided technique for blockade of these articular branches to the hip, the PENG (Pericapsular Nerve Group) block reported significantly reduced pain scores compared with baseline. Roy et al 2019 recommended the use of PENG block together with LFCN block as adjunctive to cover the lateral surgical incision.

Conditions

Proximal Femur Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Fascia iliaca block

Patients will receive Fascia iliaca block

Group Type: ACTIVE_COMPARATOR

Fascia iliaca block

Intervention Type: PROCEDURE

A linear probe will be placed in the sagittal plane to the inguinal ligament to obtain an image of "bow-tie sign" formed by the muscle fascias, a spinal needle will be inserted 1 cm cephalad Using an in-plane approach, the fascia iliaca is penetrated, 30 mL of bupivacaine 0.25% before spinal anesthesia.

combined LFCN block with PENG block

Patients will receive a combined lateral femoral cutaneous nerve block with pericapsular nerve group block

Group Type: ACTIVE_COMPARATOR

combined LFCN block with PENG block

Intervention Type: PROCEDURE

With the patient supine, the linear probe is placed parallel to the inguinal ligament. LFCN appear as a hypoechoic oval structure between the tensor fascia lata and Sartorius muscles. The needle is inserted in plane. 5 mL of LA is injected. The PENG block will be performed in the supine position. A curvilinear probe will be placed transversely over the anterior inferior iliac spine and then rotated counterclockwise 45 degrees. the ilio pubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A spinal needle will be inserted in plane to the plane between the psoas tendon and the pubic ramus. 25 mL of bupivacaine 0.25% will be injected

Interventions

Fascia iliaca block

A linear probe will be placed in the sagittal plane to the inguinal ligament to obtain an image of "bow-tie sign" formed by the muscle fascias, a spinal needle will be inserted 1 cm cephalad Using an in-plane approach, the fascia iliaca is penetrated, 30 mL of bupivacaine 0.25% before spinal anesthesia.

Intervention Type: PROCEDURE

combined LFCN block with PENG block

With the patient supine, the linear probe is placed parallel to the inguinal ligament. LFCN appear as a hypoechoic oval structure between the tensor fascia lata and Sartorius muscles. The needle is inserted in plane. 5 mL of LA is injected. The PENG block will be performed in the supine position. A curvilinear probe will be placed transversely over the anterior inferior iliac spine and then rotated counterclockwise 45 degrees. the ilio pubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A spinal needle will be inserted in plane to the plane between the psoas tendon and the pubic ramus. 25 mL of bupivacaine 0.25% will be injected

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status I, II and III.

Exclusion Criteria

• Patient refusal.
• Neuromuscular diseases
• Hematological diseases
• Bleeding abnormality
• Coagulation abnormality.
• Psychiatric diseases.
• Local skin infection at the site of the block.
• Local skin sepsis at the site of the block
• Known intolerance to the study drugs.
• Body Mass Index > 40 Kg/m2.
• Multiple trauma patients.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mona A Hasheesh, MD

Role: STUDY_CHAIR

Professor of Anesthesia and Surgical Intensive care,,P

Eiad A Ramzy, MD

Role: STUDY_DIRECTOR

Associate Professor of Anesthesia and Surgical Intensive care,

Locations

Mansoura University, emergency hospital

Al Mansurah, DK, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mona A Hasheesh, MD

Role: CONTACT

drmonahasheesh@hotmail.com

00201027034020

Eiad A Ramzy, MD

Role: CONTACT

eiadramzy@yahoo.com

00201005774079

Facility Contacts

Mona A Hasheesh, MD

Role: primary

drmonahasheesh@hotmail.com

00201027034020

Eyad A Ramzy, MD

Role: backup

eiadramzy@yahoo.com

00201005774079

Other Identifiers

MFM-IRB, MD.20.02.280

Identifier Type: -

Identifier Source: org_study_id