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

NCT06636331 | Enrolling By Invitation

• 1 other identifier: Udayana University
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pain, Postoperative

Keywords

Pain Postoperative

Outcome Measures

Primary Outcomes (1)

• The Quality of Postoperative Analgesia

  Assess the local anesthetic dosage in milligrams from patient controlled analgesia Machine for attempt dose, delivered dose and 24 hours total doses.

  24 hours

Secondary Outcomes (3)

• Delta Interleukin-6

  3 days

• Hemodynamic Stability

  24 hours

• Questionnaire of Recovery 40 (QoR-40)

  24 hours

Study Arms (2)

Treatment S-FICB Arm

EXPERIMENTAL

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

Other: Continuous Suprainguinal Fascia Iliaca Compartment Block

Treatment Epidural Arm

EXPERIMENTAL

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

Other: Continuous Epidural

Interventions

Continuous Suprainguinal Fascia Iliaca Compartment Block OTHER

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

Treatment S-FICB Arm

Continuous Epidural OTHER

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

Treatment Epidural Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Patients with contraindications to regional anesthesia
• Patients with mental disorders or psychiatric disorders
• Patients have a history of allergy to the local anesthetic drug
• Patients or family refused to participate in the study

Sponsors & Collaborators

• Udayana University: lead

Study Sites (2)

Prof IGNG Ngoerah Hospitals

Denpasar, Bali, 80113, Indonesia

Location

Udayana University

Denpasar, Bali, 80234, Indonesia

Location

Related Publications (3)

• 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

  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.

  PMID: 34324929 BACKGROUND

• 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.

  PMID: 35620203 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Tjokorda Gde Agung Senapathi

  Udayana University

  PRINCIPAL INVESTIGATOR

• I Gusti Ngurah Mahaalit Aribawa

  Udayana University

  PRINCIPAL INVESTIGATOR

• I Gusti Agung Gede Utara Hartawan

  Udayana University

  PRINCIPAL INVESTIGATOR

• I Gede Budiartha

  Udayana University

  PRINCIPAL INVESTIGATOR

• I Made Gede Widnyana

  Udayana University

  PRINCIPAL INVESTIGATOR

• Made Agus Kresna Sucandra

  Udayana University

  STUDY CHAIR

• Ida Bagus Krisna Jaya Sutawan

  Udayana University

  STUDY CHAIR

• I Putu Pramana Suarjaya

  Udayana University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 10, 2024
• Study Start: September 20, 2024
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)