Pain, PostoperativeNCT06636331
Comparison of The Continous Suprainguinal Fascia Iliaca Compartment Block and Continous Epidural
A study testing Continuous Suprainguinal Fascia Iliaca Compartment Block and Continuous Epidural in people with Pain, Postoperative, run by Udayana University at 2 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Continuous Suprainguinal Fascia Iliaca Compartment Block and Continuous Epidural
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesIndonesia
- Study dates
- 20 Sep 2024to 30 Oct 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients is planned for cephalomedullary nailing surgery
- Patients with BMI 18 - 30 kg/m2
- Patients with ASA physical status I - III
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia2 sites
Prof IGNG Ngoerah Hospitals
Denpasar, Bali, 80113
Udayana University
Denpasar, Bali, 80234
About this study
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
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Continuous Suprainguinal Fascia Iliaca Compartment Block, Continuous Epidural
- Keywords
- Pain Postoperative
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Suprainguinal Fascia Iliaca Compartment BlockOther
Using PCRA and Local Anesthetic Ropivacaine 0.2% continuous 2ml/hr and demand dose 5ml as needed.
Continuous EpiduralOther
Using PCEA and Local Anesthetic Ropivacaine 0.2% continuous 2ml/hr and demand dose 5ml as needed.
| Study group | Role | What they receive |
|---|---|---|
| Treatment S-FICB Arm | Experimental | S-FICB with PCRA using Ropivacaine 0.2% continuous 2ml/hr, demand dose 5ml as needed. Receives: Other: Continuous Suprainguinal Fascia Iliaca Compartment Block |
| Treatment Epidural Arm | Experimental | Epidural with PCEA using Ropivacaine 0.2% continuous 2ml/hr, demand dose 5ml as needed. Receives: Other: Continuous Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quality of Postoperative Analgesia
Assess the local anesthetic dosage in milligrams from patient controlled analgesia Machine for attempt dose, delivered dose and 24 hours total doses.
Measured: 24 hours
Secondary outcomes (3)
Delta Interleukin-6
Laboratory report for interleukin-6 preoperative and 24 hours posoperative then calculate the delta Interleukin-6
Measured: 3 days
Hemodynamic Stability
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.
Measured: 24 hours
Questionnaire of Recovery 40 (QoR-40)
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).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start20 Sep 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riko, MD, Udayana University
- Investigators
- Tjokorda Gde Agung Senapathi, Principal investigator, Udayana UniversityI Gusti Ngurah Mahaalit Aribawa, Principal investigator, Udayana UniversityI Gusti Agung Gede Utara Hartawan, Principal investigator, Udayana UniversityI Gede Budiartha, Principal investigator, Udayana UniversityI Made Gede Widnyana, Principal investigator, Udayana UniversityMade Agus Kresna Sucandra, Study chair, Udayana UniversityIda Bagus Krisna Jaya Sutawan, Study chair, Udayana UniversityI Putu Pramana Suarjaya, Study chair, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636331
- Sponsor's protocol ID
- Udayana University
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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.
PubMed 34324929Zhu 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.
PubMed 35620203