Comparison of The Continous Suprainguinal Fascia Iliaca Compartment Block and Continous Epidural

NCT ID: NCT06636331

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-20

Study Completion Date

2024-10-30

Brief Summary

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This study evaluates the effectiveness of postoperative analgesia quality, Interleukin-6, Hemodynamic stability and QoR-40 of continuous Suprainguinal Fascia Iliaca Compartment Block (S-FICB) compared with continuous epidural in patients undergoing cephalomedullary nailing surgery.

Half of participants will receive continuous S-FICB with patient control regional analgesia using ropivacaine 0.2% continue 2ml/hr and demand dose 5ml as needed, while the other half will receive continuous epidural with patient control epidural analgesia using same regimen.

Detailed Description

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The Continuous Suprainguinal Fascia Iliaca Compartment Block (S-FICB) and continuous epidural are regional anaesthesia that can be used to relieve postoperative pain of femur surgery. But there are few studies have been done to compare both techniques.

The S-FICB is an alternate peripheral nerve block technique using local anaesthetic administered into the fascia iliaca compartment at the inguinal region which targets the femoral, obturator and lateral femoral cutaneous nerves.

The epidural is well known and proven to have an adequate analgesia effect using local anaesthetic in the epidural region targeted for femur surgery.

Based on previous studies, the effectiveness of the S-FICB single shot was no longer than 18 hours. Then we choose to continue S-FICB to find out how adequate it is. The S-FICB with ropivacaine has a proven anti-inflammatory effect for the first 24 hours postoperative.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment S-FICB Arm

S-FICB with PCRA using Ropivacaine 0.2% continuous 2ml/hr, demand dose 5ml as needed.

Group Type EXPERIMENTAL

Continuous Suprainguinal Fascia Iliaca Compartment Block

Intervention Type OTHER

Using PCRA and Local Anesthetic Ropivacaine 0.2% continuous 2ml/hr and demand dose 5ml as needed.

Treatment Epidural Arm

Epidural with PCEA using Ropivacaine 0.2% continuous 2ml/hr, demand dose 5ml as needed.

Group Type EXPERIMENTAL

Continuous Epidural

Intervention Type OTHER

Using PCEA and Local Anesthetic Ropivacaine 0.2% continuous 2ml/hr and demand dose 5ml as needed.

Interventions

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Continuous Suprainguinal Fascia Iliaca Compartment Block

Using PCRA and Local Anesthetic Ropivacaine 0.2% continuous 2ml/hr and demand dose 5ml as needed.

Intervention Type OTHER

Continuous Epidural

Using PCEA and Local Anesthetic Ropivacaine 0.2% continuous 2ml/hr and demand dose 5ml as needed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients is planned for cephalomedullary nailing surgery
2. Patients with BMI 18 - 30 kg/m2
3. Patients with ASA physical status I - III

Exclusion Criteria

1. Patients with contraindications to regional anesthesia
2. Patients with mental disorders or psychiatric disorders
3. Patients have a history of allergy to the local anesthetic drug
4. Patients or family refused to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Udayana University

OTHER

Sponsor Role lead

Responsible Party

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Riko, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tjokorda Gde Agung Senapathi

Role: PRINCIPAL_INVESTIGATOR

Udayana University

I Gusti Ngurah Mahaalit Aribawa

Role: PRINCIPAL_INVESTIGATOR

Udayana University

I Gusti Agung Gede Utara Hartawan

Role: PRINCIPAL_INVESTIGATOR

Udayana University

I Gede Budiartha

Role: PRINCIPAL_INVESTIGATOR

Udayana University

I Made Gede Widnyana

Role: PRINCIPAL_INVESTIGATOR

Udayana University

Made Agus Kresna Sucandra

Role: STUDY_CHAIR

Udayana University

Ida Bagus Krisna Jaya Sutawan

Role: STUDY_CHAIR

Udayana University

I Putu Pramana Suarjaya

Role: STUDY_CHAIR

Udayana University

Locations

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Prof IGNG Ngoerah Hospitals

Denpasar, Bali, Indonesia

Site Status

Udayana University

Denpasar, Bali, Indonesia

Site Status

Countries

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Indonesia

References

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El Sherbeny, S., Maguid, H., El Dourgham, L., Ibrahim, O., Patient Controlled Analgesia: Fascia Iliaca Compartment Block Versus Epidural Analgesia for Postoperative Pain Relief Following Total Knee Replacement Under Spinal Anesthesia: A Comparative Study. Zagazig University Medical Journal, 2022; (318-325): -.doi: 10.21608/zumj.2020.28085.1821

Reference Type BACKGROUND

Azizoglu M, Rumeli S. Comparison of the suprainguinal fascia iliaca compartment block with continuous epidural analgesia in patients undergoing hip surgeries: a retrospective study. Braz J Anesthesiol. 2022 May-Jun;72(3):342-349. doi: 10.1016/j.bjane.2021.07.006. Epub 2021 Jul 26.

Reference Type BACKGROUND
PMID: 34324929 (View on PubMed)

Zhu K, Zheng F, Wang C, Ding L. Effect of Ultrasound-Guided Fascia Iliac Compartment Block on Serum NLRP3 and Inflammatory Factors in Patients with Femoral Intertrochanteric Fracture. Comput Math Methods Med. 2022 May 17;2022:1944659. doi: 10.1155/2022/1944659. eCollection 2022.

Reference Type BACKGROUND
PMID: 35620203 (View on PubMed)

Related Links

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https://resources.wfsahq.org/atotw/fascia-iliaca-compartment-block-an-update/

The World Federation of Societies of Anaesthesiologists have updated information about Fascia Iliaca Compartment Block

Other Identifiers

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Udayana University

Identifier Type: -

Identifier Source: org_study_id

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