Which Analgesia is Better for Proximal Femoral Fractures?

- Efficacy of Combined Lateral Femoral Cutaneous Nerve Block With Pericapsular Nerve Group Block Versus Fascia Iliaca Block in Proximal Femoral Fractures

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.

Study Overview

• Status: Unknown
• Conditions: Proximal Femur Fracture
• Intervention / Treatment: Procedure: Fascia iliaca block; Procedure: combined LFCN block with PENG block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Recruiting
      • Mansoura University, emergency hospital
      • Contact: Mona A Hasheesh, MD; Phone Number: 00201027034020; Email: drmonahasheesh@hotmail.com
      • Contact: Eyad A Ramzy, MD; Phone Number: 00201005774079; Email: eiadramzy@yahoo.com
      • Sub-Investigator: Sherin A Bakrey, MD
      • Sub-Investigator: Shimaa A Shalaby, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fascia iliaca block; Patients will receive Fascia iliaca block	Procedure: 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.
Active Comparator: combined LFCN block with PENG block; Patients will receive a combined lateral femoral cutaneous nerve block with pericapsular nerve group block	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain measurement at rest	10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain	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	(attempted hip flexion to 15 degrees).: 10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain	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	visual analog scale (0-10, 0: no pain, 10: worst pain imaginable) during changing position from supine to sitting one	Just before surgery
The severity of postoperative pain at rest	10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain	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	(attempted hip flexion to 15 degrees): 10-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain	immediately and 1 hour at PACU, then in the surgical ward at 2,4,6,8,12,18 and 24 h after surgery.
Time to onset of Sensory blockade	cold perception loss in the lateral, anterior and medial part of the thigh (corresponding to lateral femoral cutaneous (LFC), femoral (F) and obturator (O)nerve sensory distributions, respectively)	evaluated 15 and 30 min after block administration
Time to onset of motor block	defined as assessment of quadriceps femoris muscle strength by straight leg raise test to 15 degree and classified as follow: +ve =normal power, -ve =motor weakness	evaluated 15 and 30 min after block administration
Duration of sensory block	blockade is defined as the interval between end of injection and complete end of sensory block (score=2)	postoperative 24 hours
Duration of motor block	blockade is defined as the interval between end of injection and complete end of injection and complete recovery of normal motor function (score=0),	postoperative 24 hours
Anesthesiology satisfaction for patient positioning	evaluated as 0=unsatisfactory, 1=satisfactory, 2=good or 3=optimal	just before surgery
heart rate	Changes in heart rate	pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
Mean arterial blood pressure	Changes in Mean arterial blood pressure	pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
Peripheral oxygen saturation	Changes in peripheral oxygen saturation as measured with pulse oximetry	pre-block, 15, 30 min after block, immediately after spinal anesthesia, 5min, 15min then every 30 min till end of surgery
Time for first analgesic request	defined as the time period from end of injection to the first time patient requests analgesia postoperatively	Within 24 hours after surgery
Total analgesics received	cumulative consumption of opioids during the first postoperative day	for 24 hrs after surgery
Pruritis	number of patients with pruritis	Within 24 hours after surgery
nausea	number of patients with nausea	Within 24 hours after surgery
vomiting	number of patients with vomiting	Within 24 hours after surgery

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Mona A Hasheesh, MD, Professor of Anesthesia and Surgical Intensive care,,P; Study Director: Eiad A Ramzy, MD, Associate Professor of Anesthesia and Surgical Intensive care,

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: MFM-IRB, MD.20.02.280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Yes, Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
• IPD Sharing Time Frame: after completing the study and being accepted for publication.
• IPD Sharing Access Criteria: The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No