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NCT Number: NCT06636331

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof IGNG Ngoerah Hospitals, Denpasar, Bali, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Continuous Suprainguinal Fascia Iliaca Compartment Block

Other

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

Continuous Epidural

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Delta Interleukin-6

    Time frame: 3 days

    Laboratory report for interleukin-6 preoperative and 24 hours posoperative then calculate the delta Interleukin-6

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 10, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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