Anesthesia, LocalNCT03753594
Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block
An observational study of Anesthesia, Local, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Regional tissue oxygenation saturation has been shown to increase in innervated regions after sympathetic block. The aim of this prospective observational study was to evaluate the changes of regional tissue oxygenation saturation by near-infrared spectroscopy after successful femoral nerve block with ropivacaine and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- tissue oxygenation saturation
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2018to 10 May 2019
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One hundred adult patients scheduled for elective knee arthroscopy with peripheral nerve block
Who may be able to join
- Informed consent
- American Society of Anesthesiologists physical statusⅠ-Ⅱ
- Undergo elective elective knee arthroscopy with peripheral nerve block
Who cannot join
- Refusal to participate in the study
- BMI>35
- Any contraindications to peripheral nerve block such as coagulation abnormalities, •Allergy to local anaesthetics, peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block With Ropivacaine at Different Concentrations
Regional tissue oxygenation saturation has been shown to increase in innervated regions after sympathetic block. The aim of this prospective observational study was to evaluate the changes of regional tissue oxygenation saturation by near-infrared spectroscopy after successful femoral nerve block with ropivacaine and determine whether the changes of regional tissue oxygenation saturation can be affected by the concentration of ropivacaine.
Read the detailed description
Successful peripheral nerve blocks induce sympathetic blockade, which increases local blood flow by vasodilation. The relationship between successful femoral nerve block and the variation of regional tissue oxygenation saturation was unclear.
- Conditions
- Anesthesia, Local
- Being tested
- tissue oxygenation saturation
- Keywords
- Peripheral nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue oxygenation saturationDevice
tissue oxygenation saturation
| Study group | Role | What they receive |
|---|---|---|
| H group | Patients scheduled for elective knee arthroscopy with peripheral nerve block will receive ultrasound-guided femoral nerve block with 0.5% ropivacaine. Regional tissue oxygenation saturation of the nerve innervation area and pinprick sensory tests at 5 min were assessed before the block and at 5-min intervals till 30 min after the block. Receives: Device: tissue oxygenation saturation | |
| L group | Patients scheduled for elective knee arthroscopy with peripheral nerve block will receive ultrasound-guided femoral nerve block with 0.25% ropivacaine. Regional tissue oxygenation saturation of the nerve innervation area and pinprick sensory tests were assessed at 5 min before the block and at 5-min intervals till 30 min after the block. Receives: Device: tissue oxygenation saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional tissue oxygenation saturation after successful femoral nerve block
rSO2
Measured: at 5-minute intervals till 30 minutes after regional block
Secondary outcomes (1)
Pinprick sensory scores
A 3-level scale was used to grade the intensity of sensory block using pinprick stimulation: 0=normal sensation; 1=analgesia; 2=anesthesia.
Measured: 5 minute before regional block and at 5-minute intervals till 30 minutes after regional block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start30 Nov 2018
- Primary completion10 May 2019
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xi Wu, Huazhong University of Science and Technology
- Investigators
- Xiangdong Chen, Doctor, Study director, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753594
- Sponsor's protocol ID
- XH20181118
- Status last verified
- May 2019
- First submitted
- 20 Nov 2018
- Last updated
- 13 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block With Ropivacaine at Different Concentrations
- ClinicalTrials.gov ID
- NCT03753594
- Acronym / sponsor ID
- XH20181118
- Conditions
- Anesthesia, Local
- Keywords
- Peripheral nerve block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 27 Nov 2018 (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.
Regional tissue oxygenation saturation has been shown to increase in innervated regions after sympathetic block. The aim of this prospective observational study was to evaluate the changes of regional tissue oxygenation saturation by near-infrared spectroscopy after successful femoral nerve block with ropivacaine and determine whether the changes of regional tissue oxygenation saturation can be affected by the concentration of ropivacaine.
Detailed description
Successful peripheral nerve blocks induce sympathetic blockade, which increases local blood flow by vasodilation. The relationship between successful femoral nerve block and the variation of regional tissue oxygenation saturation was unclear.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H group | – | Device: tissue oxygenation saturationPatients scheduled for elective knee arthroscopy with peripheral nerve block will receive ultrasound-guided femoral nerve block with 0.5% ropivacaine. Regional tissue oxygenation saturation of the nerve innervation area and pinprick sensory tests at 5 min were assessed before the block and at 5-min intervals till 30 min after the block. |
| L group | – | Device: tissue oxygenation saturationPatients scheduled for elective knee arthroscopy with peripheral nerve block will receive ultrasound-guided femoral nerve block with 0.25% ropivacaine. Regional tissue oxygenation saturation of the nerve innervation area and pinprick sensory tests were assessed at 5 min before the block and at 5-min intervals till 30 min after the block. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred adult patients scheduled for elective knee arthroscopy with peripheral nerve block
Key inclusion criteria (3 listed)
- Informed consent
- American Society of Anesthesiologists physical statusⅠ-Ⅱ
- Undergo elective elective knee arthroscopy with peripheral nerve block
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- BMI>35
- Any contraindications to peripheral nerve block such as coagulation abnormalities, •Allergy to local anaesthetics, peripheral neuropathy
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 |
|---|---|---|
| tissue oxygenation saturationtissue oxygenation saturation | Device | H group, L group |
Primary outcome
Regional tissue oxygenation saturation after successful femoral nerve block
Time frame: at 5-minute intervals till 30 minutes after regional block
rSO2
1 secondary outcome
Pinprick sensory scores
Time frame: 5 minute before regional block and at 5-minute intervals till 30 minutes after regional block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
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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.
Xiangdong Chen, Doctor study director
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Local, run by Huazhong University of Science and Technology 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 13 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Regional tissue oxygenation saturation after successful femoral nerve block (time frame: at 5-minute intervals till 30 minutes after regional block). 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 13 May 2019.