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Clinical Trials/NCT07594366
NCT07594366CompletedNot Applicable

Effectiveness of Suprainguinal Facia Iliaca Block in Maximizing the Feasibility of Positioning for Spinal Anesthesia in Patients With Hip and Proximal Femur Fractures, a Placebo Randomized Controlled Study

Suez Canal University1 site in 1 country40 target enrollmentStarted: September 1, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1

Study Overview

Brief Summary

In this study, we assessed the effect of suprainguinal facia iliaca block in maximizing the feasibility of positioning for spinal anaesthesia in patients with hip and proximal femur fractures by determining the angle that could be achieved and success rate of spinal anesthesia The control group received a sham block with the same technique of suprainguinal fascia iliaca block before being given spinal anaesthesia.

The interventional group received suprainguinal fascia iliaca block before being given spinal anaesthesia.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Masking Description

The patient and the caregiver were blinded to the injectate in the procedure. The investigator was blinded to the solution that was used for the block, as a third person had prepared the injectate.

The one who assessed the sitting angle was blinded to the group of the patient.

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients are ASA I (American Society of Anesthesiologists physical status grade I) = normal healthy patients, ASA II (American Society of Anesthesiologists physical status grade II) = patients with mild systemic disease and no functional limitations, or ASA III (American Society of Anesthesiologists physical status grade III) = patients with moderate systemic disease and some functional limitations.
  • Patients having hip and/or proximal femur fractures.

Exclusion Criteria

  • Patient refusal to participate in the study
  • Patients' refusal for regional anaesthesia
  • Patients have other combined fractures rather than unilateral hip or proximal femur fractures.
  • Underlying coagulopathies.
  • Local infection.
  • Known allergy to LA.
  • Body mass index (BMI) more than 40 kg/m².
  • Heart block greater than first-degree.
  • Renal and hepatic dysfunction.
  • Neurological diseases such as Alzheimer's and dementia or apparent psychological instability.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abdelrhman Alshawadfy

professor

Suez Canal University

Study Sites (1)

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