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

October 12, 2024 updated by: Riko, MD, Udayana University

Comparison of The Continous Suprainguinal Fascia Iliaca Compartment Block and Continous Epidual on The Quality of Postoperative Analgesia, Interleukin-6, Hemodynamic Stability and QoR-40 for Cephalomedullary Nailing Surgeries

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Bali
      • Denpasar, Bali, Indonesia, 80113
        • Prof IGNG Ngoerah Hospitals
      • Denpasar, Bali, Indonesia, 80234
        • Udayana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment S-FICB Arm
S-FICB with PCRA using Ropivacaine 0.2% continuous 2ml/hr, demand dose 5ml as needed.
Other: Continuous Suprainguinal Fascia Iliaca Compartment Block
Using PCRA and Local Anesthetic Ropivacaine 0.2% continuous 2ml/hr and demand dose 5ml as needed.
Experimental: Treatment Epidural Arm
Epidural with PCEA using Ropivacaine 0.2% continuous 2ml/hr, demand dose 5ml as needed.
Other: Continuous Epidural
Using PCEA and Local Anesthetic Ropivacaine 0.2% continuous 2ml/hr and demand dose 5ml as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Quality of Postoperative Analgesia
Time Frame: 24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delta Interleukin-6
Time Frame: 3 days
Laboratory report for interleukin-6 preoperative and 24 hours posoperative then calculate the delta Interleukin-6
3 days
Hemodynamic Stability
Time Frame: 24 hours
Monitoring blood pressure category as stable or not stable. Stable if systolic blood pressure is above 100 mmHg. Not Stable if systolic blood pressure is under 100 mmHg.
24 hours
Questionnaire of Recovery 40 (QoR-40)
Time Frame: 24 hours
Assess the subject recovery condition using questionnaires QoR-40. The score range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Udayana University

Investigators

  • Principal Investigator: 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
  • Study Chair: Made Agus Kresna Sucandra, Udayana University
  • Study Chair: Ida Bagus Krisna Jaya Sutawan, Udayana University
  • Study Chair: I Putu Pramana Suarjaya, Udayana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2024

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

October 6, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 12, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Udayana University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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