Which Analgesia is Better for Proximal Femoral Fractures?

NCT04309539 | Unknown DMC

• 1 other identifier: MFM-IRB, MD.20.02.280
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Femur Fracture

Outcome Measures

Primary Outcomes (1)

• Time of performance of Spinal Anesthesia

  Is defined as the time measured from the start of positioning to the completion of the intrathecal bupivacaine injection

  just before surgery.

Secondary Outcomes (18)

• Pain measurement at rest

  immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.

• Pain measurement on movement

  immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.

• Pain measurement during positioning for spinal anesthesia

  Just before surgery

• The severity of postoperative pain at rest

  immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.

• The severity of postoperative pain on movement

  immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.

Study Arms (2)

Fascia iliaca block

ACTIVE COMPARATOR

Patients will receive Fascia iliaca block

Procedure: Fascia iliaca block

combined LFCN block with PENG block

ACTIVE COMPARATOR

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

Procedure: combined LFCN block with PENG block

Interventions

Fascia iliaca block 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.

Fascia iliaca block

combined LFCN block with PENG block 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

combined LFCN block with PENG block

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, emergency hospital

Al Mansurah, DK, 050, Egypt

RECRUITING

MeSH Terms

Conditions

Proximal Femoral Fractures

Condition Hierarchy (Ancestors)

Femoral Neck Fractures; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Mona A Hasheesh, MD

  Professor of Anesthesia and Surgical Intensive care,,P

  STUDY CHAIR

• Eiad A Ramzy, MD

  Associate Professor of Anesthesia and Surgical Intensive care,

  STUDY DIRECTOR

Central Study Contacts

Mona A Hasheesh, MD

CONTACT

00201027034020; drmonahasheesh@hotmail.com

Eiad A Ramzy, MD

CONTACT

00201005774079; eiadramzy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 16, 2020
• Study Start: September 21, 2020
• Primary Completion: June 1, 2021
• Study Completion: March 1, 2022
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after completing the study and being accepted for publication.
• Access Criteria: The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients

Locations

EG (1)