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US-guided FICB After Hip Fracture: the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
supra inguinal fascia iliaca block
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 Fractures

Eligibility Criteria

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

Inclusion Criteria:

  • patients aged above 65 years , american society of anesthesiologists physical status I to III , and with body mass index (BMI) of 35 kg/m² or less , undergoing hip fracture surgical repair .

Exclusion Criteria:

  • inability or refusal to sign informed consent
  • younger than 65 years
  • BMI greater than 35 kg/m²
  • presence of contraindications for regional nerve block or spinal anesthesia
  • impaired cognition or dementia
  • multiple fractures

Sites / Locations

  • Mechaal Benali

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

group 30

group 40

group 50

Arm Description

participants received a supra inguinal fascia iliaca compartment block with 30 ml of 0.2% ropivacaine

participants received a supra inguinal fascia iliaca compartment block with 40 ml of 0.2% ropivacaine

participants received a supra inguinal fascia iliaca compartment block with 50 ml of 0.2% ropivacaine

Outcomes

Primary Outcome Measures

change in pain score on movement
change in verbal ranking scale(( vrs) with 0 indicating no pain and 10 indicating the worst imaginable pain)) during passive leg elevation to 15 degrees of the affected limb , before and 30 minutes after block placement

Secondary Outcome Measures

change in pain score at rest
change in verbal ranking scale(( vrs) with 0 indicating no pain and 10 indicating the worst imaginable pain)) at rest, before and 30 minutes after block placement
assessement of sensory block
sensory assessment of Femoral nerve , obturator nerve, and lateral femoral cutaneous nerve using the cold test . in the anterior , medial and lateral aspects of the thigh.

Full Information

First Posted
December 29, 2020
Last Updated
January 2, 2021
Sponsor
University Tunis El Manar
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1. Study Identification

Unique Protocol Identification Number
NCT04692857
Brief Title
US-guided FICB After Hip Fracture: the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia
Official Title
Ultrasound-guided Fascia Iliaca Compartment Block After Hip Fracture : the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed. for group 30 ,a volume of 30 ml of 0,2 % ropivacaine had been injected for group 40 ,a volume of 40 ml of 0,2 % ropivacaine had been injected for group 50 ,a volume of 50 ml of 0,2 % ropivacaine had been injected
Detailed Description
participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed. A linear ultrasound probe was placed in the sagittal plane to obtain an image of the superior iliac spine.the fascia iliaca and sartorious,iliopsoas,and oblique internal muscles were identified by sliding the probe medially. After identifiying the "bow-tie sign"formed by the muscle fascias , an 50 mm needle was introduced 1-2 cm inferior to the inguinal ligament.using an in-plane approch, the fascia iliaca was penetrated and hydrodissected , separating the fascia iliaca from the iliac muscle. in this created space a total volume of 30 ml, 40ml or 50ml of 0.2% ropivacaine was injected , respectively to group 30 ,group 40 and group 50 . pain score at rest and with a straight leg raise of the affected limb to 15 degrees were assessed before and 30 minutes after block performance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 30
Arm Type
Experimental
Arm Description
participants received a supra inguinal fascia iliaca compartment block with 30 ml of 0.2% ropivacaine
Arm Title
group 40
Arm Type
Experimental
Arm Description
participants received a supra inguinal fascia iliaca compartment block with 40 ml of 0.2% ropivacaine
Arm Title
group 50
Arm Type
Experimental
Arm Description
participants received a supra inguinal fascia iliaca compartment block with 50 ml of 0.2% ropivacaine
Intervention Type
Procedure
Intervention Name(s)
supra inguinal fascia iliaca block
Intervention Description
injection of 30,40 or 50 ml of 0.2 ropivacaine .
Primary Outcome Measure Information:
Title
change in pain score on movement
Description
change in verbal ranking scale(( vrs) with 0 indicating no pain and 10 indicating the worst imaginable pain)) during passive leg elevation to 15 degrees of the affected limb , before and 30 minutes after block placement
Time Frame
before and 30 minutes after block placement
Secondary Outcome Measure Information:
Title
change in pain score at rest
Description
change in verbal ranking scale(( vrs) with 0 indicating no pain and 10 indicating the worst imaginable pain)) at rest, before and 30 minutes after block placement
Time Frame
before and 30 minutes after block placement
Title
assessement of sensory block
Description
sensory assessment of Femoral nerve , obturator nerve, and lateral femoral cutaneous nerve using the cold test . in the anterior , medial and lateral aspects of the thigh.
Time Frame
30 minutes after block placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients aged above 65 years , american society of anesthesiologists physical status I to III , and with body mass index (BMI) of 35 kg/m² or less , undergoing hip fracture surgical repair . Exclusion Criteria: inability or refusal to sign informed consent younger than 65 years BMI greater than 35 kg/m² presence of contraindications for regional nerve block or spinal anesthesia impaired cognition or dementia multiple fractures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mechaal benali, PROFESSOR
Organizational Affiliation
university manar Tunis tunisia
Official's Role
Study Chair
Facility Information:
Facility Name
Mechaal Benali
City
Nabeul
State/Province
Mrezga
ZIP/Postal Code
8000
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

US-guided FICB After Hip Fracture: the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia

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