Clinical trial NCT04692428: Comparison of the Ultrasound Supra-inguinal Fascia Iliaca Block vs Femoral Nerve Block
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Keywords: analgesia
hip fracture
nerve block
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Positioning pain before performing spinal anesthesia
timeFrame: 20 minutes after realization of blocks
Secondary outcomes:
measure: Postoperative pain
timeFrame: at the third, sixth, twelfth and twenty-four hours postoperatively
measure: quality of patient placement in the sitting position
timeFrame: after 20 minutes of realization of block
measure: The level of sensory block at 20 minutes after realization of block
timeFrame: before and 20 minutes after realization of blocks
measure: Patient satisfaction
timeFrame: five minutes after the end of the realization of spinal anesthesia
Other outcomes:
Locations:
city: Nabeul
country: Tunisia
facility: Mechaal Benali
state: Mrezga
Study officials:
affiliation: university manar Tunis tunisia
name: mechaal benali, PROFESSOR
role: PRINCIPAL_INVESTIGATOR
References: