US-guided FICB After Hip Fracture: the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia
Ultrasound-guided Fascia Iliaca Compartment Block After Hip Fracture : the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia
1 other identifier
interventional
75
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedFirst Submitted
Initial submission to the registry
December 29, 2020
CompletedFirst Posted
Study publicly available on registry
January 5, 2021
CompletedJanuary 5, 2021
January 1, 2021
8 months
December 29, 2020
January 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
change in pain score at rest
before and 30 minutes after block placement
assessement of sensory block
30 minutes after block placement
Study Arms (3)
group 30
EXPERIMENTALparticipants received a supra inguinal fascia iliaca compartment block with 30 ml of 0.2% ropivacaine
group 40
EXPERIMENTALparticipants received a supra inguinal fascia iliaca compartment block with 40 ml of 0.2% ropivacaine
group 50
EXPERIMENTALparticipants received a supra inguinal fascia iliaca compartment block with 50 ml of 0.2% ropivacaine
Interventions
injection of 30,40 or 50 ml of 0.2 ropivacaine .
Eligibility Criteria
You may qualify if:
- 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 .
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mechaal Benali
Nabeul, Mrezga, 8000, Tunisia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
mechaal benali, PROFESSOR
university manar Tunis tunisia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
December 29, 2020
First Posted
January 5, 2021
Study Start
January 2, 2020
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
January 5, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share