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Femoral FracturesNCT05172869

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

A study testing Suprainguinal Performed FICB and Infrainguinal Performed FICB in people with Femoral Fractures and Postoperative Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Femoral Fractures, Postoperative Pain
What is being tested?
Suprainguinal Performed FICB and Infrainguinal Performed FICB
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteTurkey (Türkiye)
Study dates
9 Feb 2022to 27 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara City Hospital

    Ankara

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

After ethical committee approval, at least 68 patients who will undergo surgery for femoral fracture will be included in the study. Our study was planned as prospective, randomized, double-blind.

At least 68 patients of both sexes, 18 years of age and older, American Society of Anesthesiologists Score-1,2,3 ( ASA 1,2,3) who will undergo surgery for femoral fracture will be included.

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).

Routine monitoring [electrocardiogram (ECG), noninNRSive blood pressure, peripheral oxygen saturation (SpO2) measured by pulse oximetry] will be performed for both groups, and heart rate (beats/minute), blood pressure (mmHg), SpO2 (%) will be recorded. Pain intensity, as measured by the 11-Point Numerical Rating Scale (NRS) for pain (0: no pain, 10: worst pain imaginable) will be recorded. All patients in both groups will be administered a mixture of 200mg 2% lidocaine and 0.25% 75mg bupivacaine, with a total volume of 40 ml, with an 80 mm peripheral block needle, accompanied by ultrasonography (US). To avoid toxic doses of local anesthetics, patients with a body weight of less than 50 kg will not be included in the study.

Patients in both groups will undergo sensory examination every 5 minutes for 30 minutes after FICB is performed (sensory: 0, hypoesthesia: 1, no sensation: 2). Sensory examination scoring will be performed and recorded separately for femoral nerve, lateral femoral cutaneous nerve and obturator nerve derivations. Patients with NRS 0-4 and a total sensory scale score for three leads 3 out of 6 will be considered suitable for positioning spinal anesthesia. Among these patients, patients with a sensory scale of 5 and 6 points will be considered as complete block, and their full block duration will be recorded.

The patient will be placed on the operating table in the lateral decubitus position with the fractured side down, and the dynamic NRS (pain score during the lateral decubitus positioning movement with the patient's fractured side down) and static NRS value will be recorded to determine the pain caused by this position. In patients with unsuccessful sensory block application (sensory scale total is 2 or less out of 6, NRS is 5 and above), 0.03 mg/kg midazolam and 1 μg/kg fentanyl will be administered as an intravenous (iv) bolus, and this information will be recorded.

The comfort of the anesthesiologist performing the spinal anesthesia will be recorded (Poor: 0, fair: 1, good: 2, very good: 3).

The heart rate, blood pressure, SpO2 values and pain scores of the patients in both groups will be recorded as static NRS (pain score at rest) before FICB, static NRS and dynamic NRS during position for spinal anesthesia after FICB, and static NRS at the 5th minute after spinal anesthesia.

Heart rate, blood pressure and SpO2 values will be recorded every 15 minutes throughout the operation.

At the end of the operation, the patients will be followed in Postanesthesia Caring Unit (PACU) for the first 24 hours postoperatively. At the end of 24 hours, patients with a Modified Aldrete Score of 9 and above will be transferred to the ward and the follow-up will be terminated.

All patients in both groups will receive intravenous patient-controlled analgesia (PCA) prepared with morphine at the end of the operation. In the PCA device, only the bolus dose program will be selected and it will be prepared with morphine at a concentration of 0.2 mg/ml (30 mg of morphine will be supplemented with 0.09% isotonic saline, so that the total volume will be 150 ml). It will be adjusted as the bolus dose 1 mg, the lock time 20 minutes, the 4-hour limit 8 mg. Basal infusion will not be administered, and when the patient has pain with a NRS score of 5 or more in the postoperative period, bolus administration will be performed with the patient button of the PCA device and each bolus will be recorded by the device. The use of the PCA device will be explained in detail to the patients. Patients whose have pain of NRS 5 and above, but cannot cooperate to press the bolus button (patients who show partial cooperation due to dementia, etc.) a bolus dose will be administered by PACU nurse or anesthesiologist.

Patients will be followed for the first 24 hours with vitals, postoperative pain scores (NRS) and possible opioid side effects related to IV morphine PCA administration. Static and dynamic NRS scores of the patients at 0, 2, 8, 16 and 24 hours postoperatively, at which hour in the postoperative period the first analgesic requirement (time to administer the first bolus dose with the PCA device due to NRS 5 and above), the total amount of opioid consumed during the 24 hours (mg morphine /24 hours) and any side effects (itching, nausea, vomiting, urinary retention, delirium, somnolence, respiratory distress-hypoxia, etc.) will be recorded.

Being tested
Suprainguinal Performed FICB, Infrainguinal Performed FICB
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
Medical subject headings
Femoral Fractures, Pain, Postoperative, Agnosia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Suprainguinal Performed FICBProcedure or surgery

    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

  • Infrainguinal Performed FICBProcedure or surgery

    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

Study groups in NCT05172869
Study groupRoleWhat they receive
Group S: Suprainguinal Performed FICBActive comparatorSuprainguinal Performed FICB
Receives: Procedure: Suprainguinal Performed FICB
Group I: Infrainguinal Performed FICBActive comparatorInfrainguinal Performed FICB
Receives: Procedure: Infrainguinal Performed FICB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morphine Consumption

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

    Measured: 24 hours

Secondary outcomes (6)
  1. Baseline Pain

    11-Point Numerical Rating Scale (NRS) for pain (0: no pain, 10: worst pain imaginable) will be evaluated before applying block

    Measured: 0. hours

  2. Positional Pain

    After Fascia Iliaca Compartment Block performed, the pain score during the lateral decubitus positioning movement with the patient's fractured side down for performing spinal anesthesia will be recorded by NRS (11-Point Numerical Rating Scale)

    Measured: 0. hours

  3. Postoperative 2nd Hour Pain

    11-Point Numerical Rating Scale (NRS) for pain (0: no pain, 10: worst pain imaginable) will be evaluated postoperative 2nd hour

    Measured: 2. hours

  4. Postoperative 8th Hour Pain

    11-Point Numerical Rating Scale (NRS) for pain (0: no pain, 10: worst pain imaginable) will be evaluated postoperative 8th hour

    Measured: 8. hours

  5. Postoperative 16th Hour Pain

    11-Point Numerical Rating Scale (NRS) for pain (0: no pain, 10: worst pain imaginable) will be evaluated postoperative 16th hour

    Measured: 16. hours

  6. Postoperative 24th Hour Pain

    11-Point Numerical Rating Scale (NRS) for pain (0: no pain, 10: worst pain imaginable) will be evaluated postoperative 24th hour

    Measured: 24. hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2021
  2. Study start9 Feb 2022
  3. Primary completion30 Apr 2022
  4. Study completion27 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05172869
Sponsor's protocol ID
Ankara City Hospital
Status last verified
Nov 2022
First submitted
16 Oct 2021
Last updated
1 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Suprainguinal Performed FICB and Infrainguinal Performed FICB in people with Femoral Fractures and Postoperative Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morphine Consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.

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