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

Not Applicable

Completed

• Conditions: Hip Fracture
• Interventions: Procedure: Locoregional analgesia

• Registration Number: NCT04692428
• Lead Sponsor: University Tunis El Manar

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

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 Timeline

• Study Start: 2019-04-20
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Study First Submitted: 2020-12-25
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-02
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FNB group	Locoregional analgesia	ultrasound femoral nerve block
FIBSI group	Locoregional analgesia	ultrasound supra inguinal Fascia iliaca block

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	at the third, sixth, twelfth and twenty-four hours postoperatively	Postoperative pain was assessed by the Simple Verbal Scale (SVS) 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 quality of patient positioning was subjectively rated as unsatisfactory, good or optimal depending on the ease of positioning for spinal anesthesia
The level of sensory block at 20 minutes after realization of block	before and 20 minutes after realization of blocks	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
Patient satisfaction	five minutes after the end of the realization of spinal anesthesia	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.

Trial Locations

Locations (1)

Mechaal Benali; 🇹🇳 Nabeul, Mrezga, Tunisia