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

Primary Purpose

Hip Fracture

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Locoregional analgesia
Sponsored by
University Tunis El Manar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hip Fracture focused on measuring analgesia, hip fracture, nerve block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mechaal Benali

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FIBSI group

FNB group

Arm Description

ultrasound supra inguinal Fascia iliaca block

ultrasound femoral nerve block

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative pain
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
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
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
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.

Full Information

First Posted
December 25, 2020
Last Updated
January 2, 2021
Sponsor
University Tunis El Manar
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1. Study Identification

Unique Protocol Identification Number
NCT04692428
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 20, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Tunis El Manar

4. Oversight

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

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
analgesia, hip fracture, nerve block

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FIBSI group
Arm Type
Experimental
Arm Description
ultrasound supra inguinal Fascia iliaca block
Arm Title
FNB group
Arm Type
Experimental
Arm Description
ultrasound femoral nerve block
Intervention Type
Procedure
Intervention Name(s)
Locoregional analgesia
Intervention Description
the supra-inguinal fascia iliaca block versus the femoral nerve block
Primary Outcome Measure Information:
Title
Positioning pain before performing spinal anesthesia
Description
Pain in positioning was assessed by measuring the simple verbal scale (0= no pain- 4= worst pain possible) after 20 minutes for realization block
Time Frame
20 minutes after realization of blocks
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative pain was assessed by the Simple Verbal Scale (SVS) at the third, sixth, twelfth and twenty-four hours postoperatively
Time Frame
at the third, sixth, twelfth and twenty-four hours postoperatively
Title
quality of patient placement in the sitting position
Description
The quality of patient positioning was subjectively rated as unsatisfactory, good or optimal depending on the ease of positioning for spinal anesthesia
Time Frame
after 20 minutes of realization of block
Title
The level of sensory block at 20 minutes after realization of block
Description
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
Time Frame
before and 20 minutes after realization of blocks
Title
Patient satisfaction
Description
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.
Time Frame
five minutes after the end of the realization of spinal anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mechaal benali, PROFESSOR
Organizational Affiliation
university manar Tunis tunisia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mechaal Benali
City
Nabeul
State/Province
Mrezga
ZIP/Postal Code
8000
Country
Tunisia

12. IPD Sharing Statement

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

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