Skip to main content
Clinical Trials/NCT06636331
NCT06636331
Enrolling By Invitation
Not Applicable

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

Udayana University2 sites in 1 country46 target enrollmentSeptember 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Udayana University
Enrollment
46
Locations
2
Primary Endpoint
The Quality of Postoperative Analgesia
Status
Enrolling By Invitation
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2024
End Date
October 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Udayana University
Responsible Party
Principal Investigator
Principal Investigator

Riko, MD

Principal Investigator

Udayana University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Delta Interleukin-6(3 days)
  • Hemodynamic Stability(24 hours)
  • Questionnaire of Recovery 40 (QoR-40)(24 hours)

Study Sites (2)

Loading locations...

Similar Trials