Suprainguinal Facia Iliaca Block in Maximizing the Feasibility of Positioning for Spinal Anesthesia

NCT07594366 | Completed DMC

• 1 other identifier: Fascia Iliaca
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anaesthetic Poisoning; Spinal Anaesthesia

Keywords

spinal anaesthesia positioning

Outcome Measures

Primary Outcomes (1)

• Degree of Fowler's position

  Measure and compare the maximum tolerable degree of Fowler's position after fascia iliaca compartment block (FICB) and sham block in order to give spinal anaesthesia.

  30 minutes after the fascia iliaca compartment block or sham block and till the full sitting position before spinal anaesthesia.

Study Arms (2)

Fascia iliaca compartment block

ACTIVE COMPARATOR

Fascia iliaca block was performed at the pre-anaesthesia holding area 30 minutes before shifting the patients to the operation room with 30 ml of 0.5% bupivacaine.

Drug: Bubpivacaine

Sham group

SHAM COMPARATOR

Sham block was performed at the pre-anaesthesia holding area 30 minutes before shifting the patients to the operation room with 30 ml normal saline.

Drug: Normal Saline

Interventions

Bubpivacaine DRUG

Fascia iliaca compartment block (FICB) was performed at the pre-anaesthesia holding area 30 minutes before shifting the patients to the operation room with 30 ml of 0.5% bupivacaine.

Fascia iliaca compartment block

Normal Saline DRUG

Sham block was performed at the pre-anaesthesia holding area 30 minutes before shifting the patients to the operation room with 30 ml normal saline.

Sham group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of Medicine, Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: * Group 1 - Fascia iliaca block with bupivacaine 0.5% was performed at the pre-anaesthesia holding area 30 minutes before shifting the patients to the operation room. * Group 2 - Sham block was performed at the pre-anaesthesia holding area 30 minutes before shifting the patients to the operation room with 30 ml normal saline. Each group included 20 patients. Fascia iliaca block was performed while patients were in the supine position with all aseptic precautions.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 18, 2026
• Study Start: September 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: January 30, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

EG (1)