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Clinical Trials/NCT04692857
NCT04692857CompletedNot Applicable

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

University Tunis El Manar1 site in 1 country75 target enrollmentStarted: January 2, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
75
Locations
1
Primary Endpoint
change in pain score on movement

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

group 30

Experimental

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

Intervention: supra inguinal fascia iliaca block (Procedure)

group 40

Experimental

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

Intervention: supra inguinal fascia iliaca block (Procedure)

group 50

Experimental

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

Intervention: supra inguinal fascia iliaca block (Procedure)

Outcomes

Primary Outcomes

change in pain score on movement

Time Frame: before and 30 minutes after block placement

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 Outcomes

  • change in pain score at rest(before and 30 minutes after block placement)
  • assessement of sensory block(30 minutes after block placement)

Investigators

Sponsor
University Tunis El Manar
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mechaal Benali

professor

University Tunis El Manar

Study Sites (1)

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