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

NCT04692428 | Completed

• 1 other identifier: UTEM FIBSI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Fracture

Keywords

analgesia; hip fracture; nerve block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Postoperative pain

  at the third, sixth, twelfth and twenty-four hours postoperatively

• quality of patient placement in the sitting position

  after 20 minutes of realization of block

• The level of sensory block at 20 minutes after realization of block

  before and 20 minutes after realization of blocks

• Patient satisfaction

  five minutes after the end of the realization of spinal anesthesia

Study Arms (2)

FIBSI group

EXPERIMENTAL

ultrasound supra inguinal Fascia iliaca block

Procedure: Locoregional analgesia

FNB group

EXPERIMENTAL

ultrasound femoral nerve block

Procedure: Locoregional analgesia

Interventions

Locoregional analgesia PROCEDURE

the supra-inguinal fascia iliaca block versus the femoral nerve block

FIBSI group; FNB group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Mechaal Benali

Nabeul, Mrezga, 8000, Tunisia

Location

MeSH Terms

Conditions

Hip Fractures; Agnosia

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• mechaal benali, PROFESSOR

  university manar Tunis tunisia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: December 31, 2020
• Study Start: April 20, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

TU (1)