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Clinical Trials/NCT04692428
NCT04692428
Completed
Not Applicable

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

University Tunis El Manar1 site in 1 country100 target enrollmentApril 20, 2019
ConditionsHip Fracture

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Fracture
Sponsor
University Tunis El Manar
Enrollment
100
Locations
1
Primary Endpoint
Positioning pain before performing spinal anesthesia
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2019
End Date
December 20, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Tunis El Manar
Responsible Party
Principal Investigator
Principal Investigator

Mechaal Benali

Professor

University Tunis El Manar

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

Outcomes

Primary Outcomes

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 Outcomes

  • 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 Sites (1)

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