Comparison of Two Different Approaches in the Fascia Iliaca Compartment Block in Femoral Fracture Surgery

NCT05172869 | Completed

• 1 other identifier: Ankara City Hospital
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Fascia Iliaca Compartment Block (FICB) is a popular regional anaesthetic technique for surgical procedures involving the hip joint and femur. The FICB may be thought of as an anterior approach to the lumbar plexus where local anaesthetic is injected proximally beneath the fascia iliaca, with the aim of blocking the femoral nerve ,obturator nerve and lateral cutaneous nerve of thigh simultaneously. In addition to providing effective analgesia, peripheral nerve blocks are increasingly preferred especially in frail patient groups such as the geriatric population which femoral fractures are the most common, because of their advantages such as avoiding the complications of neuraxial anesthesia and the side effects of opioids. FICB can be applied with ultrasound-guided suprainguinal or infrainguinal approaches. Studies on the superiority of the two methods used in clinical practice are limited. In this study, it is aimed to compare the suprainguinal (Group S) and infrainguinal (Group I) approaches of FICB applied in the preoperative period in femoral fractures in which spinal anesthesia method was chosen. These two methods will be compared in terms of postoperative pain scores (11-point numeric scale), morphine consumption (by intravenous patient controlled analgesia for postoperative 24 hours) and possible side effects-complications.

Conditions

Femoral Fractures; Postoperative Pain

Keywords

Nerve Block [E03.155.086.711]; Femoral Fractures [C26.558.276]; Hip Fractures [C26.558.276.425]; Analgesia [E03.091]; Analgesia, Patient-Controlled [E03.091.120]; Pain, Postoperative [C23.888.592.612.832]; Pain, Procedural [C23.888.592.612.860]; Suprainguinal Fascia Iliaca Block; Infrainguinal Fascia Iliaca Block; Opioid Consumption

Outcome Measures

Primary Outcomes (1)

• Morphine Consumption

  postoperative morphine consumption will be recorded as milligrams for first 24 hours by intravenous patient controlled analgesia (PCA) (mg/24 hours)

  24 hours

Secondary Outcomes (6)

• Baseline Pain

  0. hours

• Positional Pain

  0. hours

• Postoperative 2nd Hour Pain

  2. hours

• Postoperative 8th Hour Pain

  8. hours

• Postoperative 16th Hour Pain

  16. hours

Study Arms (2)

Group S: Suprainguinal Performed FICB

ACTIVE COMPARATOR

Suprainguinal Performed FICB

Procedure: Suprainguinal Performed FICB

Group I: Infrainguinal Performed FICB

ACTIVE COMPARATOR

Infrainguinal Performed FICB

Procedure: Infrainguinal Performed FICB

Interventions

Suprainguinal Performed FICB PROCEDURE

Linear ultrasound probe places above inguinal ligament sagittally, close to the femoral crease and superior-lateral to the femoral artery. It is aimed to spreading local anesthetics under the fascia iliaca medial-laterally

Group S: Suprainguinal Performed FICB

Infrainguinal Performed FICB PROCEDURE

Linear ultrasound probe places below inguinal ligament transversally, close to the femoral crease and lateral to the femoral artery. It is aimed to spreading local anesthetics under the fascia iliaca medial-laterally

Group I: Infrainguinal Performed FICB

Eligibility Criteria

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

You may qualify if:

• Undergo femoral fracture surgery
• ASA 1-2-3
• years and older
• Accepting preoperative fascia iliaca compartment block application

You may not qualify if:

• Patients younger than 18 years
• Patients with an ASA score of 4 and greater than 4
• Patients who are unable to read, understand and sign the consent form
• Patients who do not want to sign the consent form
• Patients deemed unsuitable by the investigator
• Patients with body weight less than 50 kg
• Patients with hypersensitivity to local anesthetics
• Patients with known neuropsychiatric disease
• Patients with coagulopathic disease or anticoagulant drug use that interferes with the application of neuraxial anesthesia or peripheral nerve blockade
• Patients with infection or active skin lesion at the application site of neuraxial anesthesia or peripheral nerve blockade
• Patients who need to be switched to general anesthesia due to spinal anesthesia insufficiency or complications before the operation is completed

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Femoral Fractures; Pain, Postoperative; Agnosia; Pain

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Ayşe Lafçı

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Patients who will undergo surgery will be divided into two randomized groups, each containing 34 patients, in the preoperative unit with a randomization program, as the group in which FICB was applied with the suprainguinal approach (Group S) and the group in which FICB was applied with the infrainguinal approach (Group I). FICB can be applied with ultrasound-guided suprainguinal or infrainguinal approaches. Studies on the superiority of the two methods used in clinical practice are limited. In this study, it is aimed to compare the suprainguinal (Group S) and infrainguinal (Group I) approaches of FICB applied in the preoperative period in femoral fractures. These two methods will be compared in terms of postoperative pain scores (11-point numeric scale), morphine consumption (by intravenous patient controlled analgesia for postoperative 24 hours) and possible side effects-complications.

Study Record Dates

• First Submitted: October 16, 2021
• First Posted: December 29, 2021
• Study Start: February 9, 2022
• Primary Completion: April 30, 2022
• Study Completion: November 27, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)