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

Hip Fractures Clinical Trial

Official title:

Ultrasound-guided Fascia Iliaca Compartment Block After Hip Fracture : the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04692857
• Other study ID #: UTEM VOL FIBSI
• Status: Completed
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: January 2021
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Procedure:
• supra inguinal fascia iliaca block
injection of 30,40 or 50 ml of 0.2 ropivacaine .

Locations

Country	Name	City	State
Tunisia	Mechaal Benali	Nabeul	Mrezga

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	before and 30 minutes after block placement
Secondary	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	before and 30 minutes after block placement
Secondary	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.	30 minutes after block placement