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

NCT ID: NCT04692857

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2020-08-31

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.

Conditions

Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

group 30

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

Group Type: EXPERIMENTAL

supra inguinal fascia iliaca block

Intervention Type: PROCEDURE

injection of 30,40 or 50 ml of 0.2 ropivacaine .

group 40

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

Group Type: EXPERIMENTAL

supra inguinal fascia iliaca block

Intervention Type: PROCEDURE

injection of 30,40 or 50 ml of 0.2 ropivacaine .

group 50

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

Group Type: EXPERIMENTAL

supra inguinal fascia iliaca block

Intervention Type: PROCEDURE

injection of 30,40 or 50 ml of 0.2 ropivacaine .

Interventions

supra inguinal fascia iliaca block

injection of 30,40 or 50 ml of 0.2 ropivacaine .

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Mechaal Benali

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mechaal benali, PROFESSOR

Role: STUDY_CHAIR

university manar Tunis tunisia

Locations

Mechaal Benali

Nabeul, Mrezga, Tunisia

Countries

Tunisia

Other Identifiers

UTEM VOL FIBSI

Identifier Type: -

Identifier Source: org_study_id