Comparison of the Ultrasound Supra-inguinal Fascia Iliaca Block vs Femoral Nerve Block

Fracture of the Upper Femoral Extremity in the Elderly Patients: Comparison of the Supra-inguinal Fascia Iliaca Block VS Femoral Nerve Block Ultrasound Guided in the Positioning and Post-operative Analgesia for Spinal Anesthesia

Patients were randomly assigned to tow groups: infrainguinal ultrasound guided iliaca fascia block (FIBSI) and femoral nerve block (FNB) for FIBSI, the probe is placed transversely between anterior superior iliac spine (ASIS) and the pubic spine. The transducer is translated laterally to identify the Sartorius muscle. Cephalic inclination of the probe. The medial end of the transducer faces towards the umbilicus, which is the final position. The 100mm neurostimulation needle is advanced in the In Plan approach to pass through the iliac fascia. Once the correct position is confirmed, 30 ml of 1% Ropivacaine is gradually injected between the iliac fascia and the iliac muscle.

For FNB, the probe was placed under the inguinal ligament. The femoral vessels and the nerve section are visualized; The 100mm neurostimulation needle is advanced in the In Plan approach and 30ml of 1% Ropivacaine has been injected along the nerve sheath

Study Overview

• Status: Completed
• Conditions: Hip Fracture
• Intervention / Treatment: Procedure: Locoregional analgesia

Detailed Description

Patients were randomly assigned to tow groups: infrainguinal ultrasound guided iliaca fascia block (FIBSI) and femoral nerve block (FNB) for FIBSI,the probe is placed transversely between the EIAS and the pubic spine,The transducer is translated laterally to identify the sartorius muscle. Cephalic inclination of the probe: The iliac muscle is located at the medial border in the shadow of the superior anterior iliac spine.The medial end of the transducer faces towards the umbilicus, which is the final position.

The anatomy identified, from superficial to deep, consisting of subcutaneous fat, internal oblique muscle, transverse abdominal muscle, iliaca fascia covering the iliac muscle. The 100mm neurostimulation needle is advanced in In Plan approach to cross the iliaca fascia. With the tip of the needle just below the iliaca fascia, 2 ml of local anesthetic was injected to confirm the location of the tip. Once the correct position is confirmed, 30 ml of 1% Ropivacaine is gradually injected between the iliac fascia and the iliac muscle.

for FNB,The probe was placed under the inguinal ligament. Femoral vessels and sectional nerve are visualized. The nerve was located, an 100mm neurostimulation needle is advanced in In Plan approach, and 30 ml of 1% Ropivacaine was injected along the nerve sheath.

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

Contacts and Locations

Study Locations

• Tunisia
  • Mrezga
    • Nabeul, Mrezga, Tunisia, 8000
      • Mechaal Benali

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA (American Society of Anesthesiologists) class I, II, and III patients scheduled for emergency surgery with the diagnosis of proximal femur fracture

Exclusion Criteria:

• hemorrhagic diathesis,
• peripheral neuropathies,
• allergy to amide local anaesthetics,
• mental disorders,
• those on analgesics within 8 hour prior to performing nerve block

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FIBSI group; ultrasound supra inguinal Fascia iliaca block	Procedure: Locoregional analgesia; the supra-inguinal fascia iliaca block versus the femoral nerve block
Experimental: FNB group; ultrasound femoral nerve block	Procedure: Locoregional analgesia; the supra-inguinal fascia iliaca block versus the femoral nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positioning pain before performing spinal anesthesia	Pain in positioning was assessed by measuring the simple verbal scale (0= no pain- 4= worst pain possible) after 20 minutes for realization block	20 minutes after realization of blocks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postoperative pain was assessed by the Simple Verbal Scale (SVS) at the third, sixth, twelfth and twenty-four hours postoperatively	at the third, sixth, twelfth and twenty-four hours postoperatively
quality of patient placement in the sitting position	The quality of patient positioning was subjectively rated as unsatisfactory, good or optimal depending on the ease of positioning for spinal anesthesia	after 20 minutes of realization of block
The level of sensory block at 20 minutes after realization of block	The quality of the sensory block was evaluated by the PinPrick Test in the external, internal and anterior part of the thigh in comparison with the same stimulation at the level of the contralateral limb. using a sterile needle at 20 minutes after realization of block on the territory of femoral, obturator and lateral cutaneous nerve of the thigh	before and 20 minutes after realization of blocks
Patient satisfaction	Patient satisfaction was evaluated after completion of spinal anesthesia by using a two-point score: 1= good, if necessary, I'll repeat it and 2= bad, I will never repeat it again.	five minutes after the end of the realization of spinal anesthesia

Collaborators and Investigators

• Sponsor: University Tunis El Manar

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2019
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: December 25, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: nerve block; analgesia; hip fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: UTEM FIBSI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No