Clinical trial NCT06636331: Comparison of The Continous Suprainguinal Fascia Iliaca Compartment Block and Continous Epidural
Official 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pain, Postoperative
Keywords: Pain Postoperative
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Quality of Postoperative Analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: Delta Interleukin-6
timeFrame: 3 days
measure: Hemodynamic Stability
timeFrame: 24 hours
measure: Questionnaire of Recovery 40 (QoR-40)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Prof IGNG Ngoerah Hospitals
state: Bali
city: Denpasar
country: Indonesia
facility: Udayana University
state: Bali
Study officials:
affiliation: Udayana University
name: Tjokorda Gde Agung Senapathi
role: PRINCIPAL_INVESTIGATOR
affiliation: Udayana University
name: I Gusti Ngurah Mahaalit Aribawa
role: PRINCIPAL_INVESTIGATOR
affiliation: Udayana University
name: I Gusti Agung Gede Utara Hartawan
role: PRINCIPAL_INVESTIGATOR
affiliation: Udayana University
name: I Gede Budiartha
role: PRINCIPAL_INVESTIGATOR
affiliation: Udayana University
name: I Made Gede Widnyana
role: PRINCIPAL_INVESTIGATOR
affiliation: Udayana University
name: Made Agus Kresna Sucandra
role: STUDY_CHAIR
affiliation: Udayana University
name: Ida Bagus Krisna Jaya Sutawan
role: STUDY_CHAIR
affiliation: Udayana University
name: I Putu Pramana Suarjaya
role: STUDY_CHAIR
References:
citation: 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
citation: 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.
citation: 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.