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

Not Applicable

• Conditions: Pain, Postoperative
• Interventions: Other: Continuous Suprainguinal Fascia Iliaca Compartment Block; Other: Continuous Epidural

• Registration Number: NCT06636331
• Lead Sponsor: Udayana University

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.

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 Timeline

• Study Start: 2024-09-20
• Status Verified: 2024-10
• Study First Submitted: 2024-10-06
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-10
• Last Update Submitted: 2024-10-12
• Last Update Posted: 2024-10-15
• Primary Completion: 2024-10-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment S-FICB Arm	Continuous Suprainguinal Fascia Iliaca Compartment Block	S-FICB with PCRA using Ropivacaine 0.2% continuous 2ml/hr, demand dose 5ml as needed.
Treatment Epidural Arm	Continuous Epidural	Epidural with PCEA using Ropivacaine 0.2% continuous 2ml/hr, demand dose 5ml as needed.

Primary Outcome Measures

Name	Time	Method
The Quality of Postoperative Analgesia	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 Outcome Measures

Name	Time	Method
Delta Interleukin-6	3 days	Laboratory report for interleukin-6 preoperative and 24 hours posoperative then calculate the delta Interleukin-6
Hemodynamic Stability	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.
Questionnaire of Recovery 40 (QoR-40)	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).

Trial Locations

Locations (2)

Udayana University; 🇮🇩 Denpasar, Bali, Indonesia

Prof IGNG Ngoerah Hospitals; 🇮🇩 Denpasar, Bali, Indonesia