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

• ClinicalTrials.gov Identifier: NCT04692428
• Recruitment Status: Completed
• First Posted: December 31, 2020
• Last Update Posted: January 5, 2021
• Sponsor: University Tunis El Manar
• Information provided by (Responsible Party): Mechaal Benali, University Tunis El Manar

Study Description

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

Condition or disease	Intervention/treatment	Phase
Hip Fracture	Procedure: Locoregional analgesia	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: 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
• Actual Study Start Date: April 20, 2019
• Actual Primary Completion Date: December 20, 2019
• Actual Study Completion Date: December 20, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Positioning pain before performing spinal anesthesia [ Time Frame: 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 :

1. Postoperative pain [ Time Frame: 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
2. quality of patient placement in the sitting position [ Time Frame: 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
3. The level of sensory block at 20 minutes after realization of block [ Time Frame: 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

4. Patient satisfaction [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Tunisia

Mechaal Benali

Nabeul, Mrezga, Tunisia, 8000

Sponsors and Collaborators

University Tunis El Manar

Investigators

• Principal Investigator: mechaal benali, PROFESSOR; university manar Tunis tunisia

More Information

• Responsible Party: Mechaal Benali, Professor, University Tunis El Manar
• ClinicalTrials.gov Identifier: NCT04692428
• Other Study ID Numbers: UTEM FIBSI
• First Posted: December 31, 2020
• Last Update Posted: January 5, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mechaal Benali, University Tunis El Manar:

analgesia; hip fracture; nerve block

Additional relevant MeSH terms:

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