Nerve BlockSASIS-FICBNCT05012137
The MEV of 0.5% Ropivacaine in Ultrasound-guided SASIS-FICB
A study testing Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) with 0.5% ropivacaine and different volume of 0.5% ropivacaine in people with Nerve Block, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The Aim of This Study is to Determine the Minimum Effective Volume of Local Anesthetic (Ropivacaine 0.5%) Required to Produce an Effective Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block（SASIS-FICB） for Surgical Anesthesia in 90% of Patients Scheduled for Elective Surgery of One… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nerve Block
- What is being tested?
- Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) with 0.5% ropivacaine and different volume of 0.5% ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2021to 25 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing hip/knee surgery
Who cannot join
- age <18 years
- body mass index >35
- inability to consent to the study
- allergy to local anesthetics
- a history of liver or renal insufficiency, coagulopathy
- clinical evidence of peripheral neuropathies, abnormalities of sensory or motor function of the FN, ON or LFCN.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing
Xulei CUI, MD, +8613717739381, cui.xulei@aliyun.com
Yuguang Huang, MD
About this study
Official title: The Minimum Effective Volume (MEV) of 0.5% Ropivacaine in Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB)
The Aim of This Study is to Determine the Minimum Effective Volume of Local Anesthetic (Ropivacaine 0.5%) Required to Produce an Effective Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block（SASIS-FICB） for Surgical Anesthesia in 90% of Patients Scheduled for Elective Surgery of One Lower Limbs.
Read the detailed description
The study is based on biased coin design, and the volume of Local Anesthetic (Ropivacaine 0.5%) for the next patient is determined by the result of the last one. In the case of block failure, the volume will be increased by 2.5ml. Conversely, block success will result in either a reduction in volume by 2.5ml (probability 11%) or no change in volume (probability 89%). A blinded assistant will assess sensory and motor blockade in each nerve territory ( the femoral, obturator and lateral femoral cutaneous nerves) at 5-min intervals up to 30 min after completion of the block. Finally, MEV90 is calculated by isotonic regression.
- Conditions
- Nerve Block
- Being tested
- Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) with 0.5% ropivacaine, different volume of 0.5% ropivacaine
- Keywords
- Minimum Effective volume, Ropivacaine, Fascia Iliaca Compartment Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) with 0.5% ropivacaineProcedure or surgery
all the patients received Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB)
different volume of 0.5% ropivacaineDrug
According to the subject's response to the injection dose, the next subject will be injected with a different volume of the drug according to the preset rules
| Study group | Role | What they receive |
|---|---|---|
| SASIS-FICB | Experimental | All subjects will be enrolled in the experimental group and receive an Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) Receives: Procedure: Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) with 0.5% ropivacaine; Drug: different volume of 0.5% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The MEV90 of 0.5%Ropivacaine in Ultrasound-guided SASIS-FICBS
We prospectively recruited patients to receive different volumes of SASIS-FICB in accordance with the sequential trial rules of biased coins until 45 successful SASIS-FICB attempts were completed. MEV90 was calculated by isometric regression.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start25 Aug 2021 (estimated)
- Primary completion25 Oct 2021 (estimated)
- Study completion25 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a dosing exploratory study.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Xulei, Peking Union Medical College Hospital
- Investigators
- Yuguang Huang, MD, Study chair, Director of Anesthesiology Department,Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012137
- Sponsor's protocol ID
- SASIS-FICB
- Acronym
- SASIS-FICB
- Status last verified
- Aug 2021
- First submitted
- 12 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Minimum Effective Volume (MEV) of 0.5% Ropivacaine in Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB)
- ClinicalTrials.gov ID
- NCT05012137
- Acronym / sponsor ID
- SASIS-FICB / SASIS-FICB
- Conditions
- Nerve Block
- Keywords
- Minimum Effective volume, Ropivacaine, Fascia Iliaca Compartment Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 25 Aug 2021 (estimated)
- Primary completion
- 25 Oct 2021 (estimated)
- Study completion
- 25 Nov 2021 (estimated)
- First posted
- 19 Aug 2021 (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.
The Aim of This Study is to Determine the Minimum Effective Volume of Local Anesthetic (Ropivacaine 0.5%) Required to Produce an Effective Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block（SASIS-FICB） for Surgical Anesthesia in 90% of Patients Scheduled for Elective Surgery of One Lower Limbs.
Detailed description
The study is based on biased coin design, and the volume of Local Anesthetic (Ropivacaine 0.5%) for the next patient is determined by the result of the last one. In the case of block failure, the volume will be increased by 2.5ml. Conversely, block success will result in either a reduction in volume by 2.5ml (probability 11%) or no change in volume (probability 89%). A blinded assistant will assess sensory and motor blockade in each nerve territory ( the femoral, obturator and lateral femoral cutaneous nerves) at 5-min intervals up to 30 min after completion of the block. Finally, MEV90 is calculated by isotonic regression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a dosing exploratory study.
| Arm | Type | Receives |
|---|---|---|
| SASIS-FICB | Experimental | Procedure: Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) with 0.5% ropivacaine, Drug: different volume of 0.5% ropivacaineAll subjects will be enrolled in the experimental group and receive an Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing hip/knee surgery
Key exclusion criteria (6 listed)
- age <18 years
- body mass index >35
- inability to consent to the study
- allergy to local anesthetics
- a history of liver or renal insufficiency, coagulopathy
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 |
|---|---|---|
| Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) with 0.5% ropivacaineall the patients received Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) | Procedure or surgery | SASIS-FICB |
| different volume of 0.5% ropivacaineAccording to the subject's response to the injection dose, the next subject will be injected with a different volume of the drug according to the preset rules | Drug | SASIS-FICB |
Primary outcome
The MEV90 of 0.5%Ropivacaine in Ultrasound-guided SASIS-FICBS
Time frame: up to 6 months
We prospectively recruited patients to receive different volumes of SASIS-FICB in accordance with the sequential trial rules of biased coins until 45 successful SASIS-FICB attempts were completed. MEV90 was calculated by isometric regression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- 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.
Yuguang Huang, MD study chair
Director of Anesthesiology Department,Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) with 0.5% ropivacaine and different volume of 0.5% ropivacaine in people with Nerve Block, run by Peking Union Medical College Hospital at 1 site in China.
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 1 inclusion and 6 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact Xulei Cui, MD (13717739381, cui.xulei@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The MEV90 of 0.5%Ropivacaine in Ultrasound-guided SASIS-FICBS (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2021.