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
- Are there results?
- None posted in the registry
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.
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06636331
- Acronym / sponsor ID
- Udayana University
- Conditions
- Pain, Postoperative
- Keywords
- Pain Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment S-FICB Arm | Experimental | Other: Continuous Suprainguinal Fascia Iliaca Compartment BlockS-FICB with PCRA using Ropivacaine 0.2% continuous 2ml/hr, demand dose 5ml as needed. |
| Treatment Epidural Arm | Experimental | Other: Continuous EpiduralEpidural with PCEA using Ropivacaine 0.2% continuous 2ml/hr, demand dose 5ml as needed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients is planned for cephalomedullary nailing surgery
- Patients with BMI 18 - 30 kg/m2
- Patients with ASA physical status I - III
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Suprainguinal Fascia Iliaca Compartment BlockUsing PCRA and Local Anesthetic Ropivacaine 0.2% continuous 2ml/hr and demand dose 5ml as needed. | Other | Treatment S-FICB Arm |
| Continuous EpiduralUsing PCEA and Local Anesthetic Ropivacaine 0.2% continuous 2ml/hr and demand dose 5ml as needed. | Other | Treatment Epidural Arm |
Primary outcome
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.
3 secondary outcomes
Delta Interleukin-6
Time frame: 3 days
Hemodynamic Stability
Time frame: 24 hours
Questionnaire of Recovery 40 (QoR-40)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- BackgroundEl 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
- Background: PubMed 34324929Azizoglu 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.
- Background: PubMed 35620203Zhu 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.
- The World Federation of Societies of Anaesthesiologists have updated information about Fascia Iliaca Compartment BlockLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tjokorda Gde Agung Senapathi principal investigator
Udayana University
I Gusti Ngurah Mahaalit Aribawa principal investigator
Udayana University
I Gusti Agung Gede Utara Hartawan principal investigator
Udayana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Quality of Postoperative Analgesia (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06636331, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.