Paravertebral BlockNCT04078347
Infrared Thermography to Evaluate the Effect of Paravertebral Block
An observational study of Paravertebral Block, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The aim of this prospective observational study was to evaluate the changes of skin temperature after the paravertebral block measured by infrared thermography. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Paravertebral Block
- What is being tested?
- Paravertebral block at T4 and T5 level
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 31 Oct 2020
- 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 70 years
- All sexes
- Adult, Older adult
Study population: Patients scheduled for elective surgery with planned paravertebral block for multimodel analgesia.
Who may be able to join
- With informed consent
- American Society of Anesthesiologists physical status Ⅰ-Ⅱ
- Undergo elective surgery with planned paravertebral block
Who cannot join
- Refusal to participate in the study
- pre-existing infection at the block site
- younger than 18-yr-old
- BMI>35
- significant thoracic kyphoscoliosis
- Those who had taken vasodilatory drugs before surgery
Show all 9Show fewer
- history of previous thoracic or breast surgery
- Preoperative analgesic medications
- 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 Skin Temperature for Evaluation of Paravertebral Block: A Prospective Observational Study Using Infrared Thermography
The aim of this prospective observational study was to evaluate the changes of skin temperature after the paravertebral block measured by infrared thermography.
Read the detailed description
Methods: Patients scheduled for elective surgery with paravertebral block will receive infrared thermography measures 5 min before the block and continous to 20 min after the block. The sensitivity, specificity of infrared thermography as diagnostic methods will be determined by receiver operator characteristic analysis.
- Conditions
- Paravertebral Block
- Being tested
- Paravertebral block at T4 and T5 level
- Keywords
- Paravertebral block, Infrared thermography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral block at T4 and T5 levelProcedure or surgery
Paravertebral block is performed at T4 and T5 level under realtime ultrasound guidenance with 10ml of 0.5% ropivacaine for each block, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Successful Paravertebral block | Pinprick test was evaluated at 20 min after Paravertebral block. Pinprick sensation was assessed using a 22-gauge short bevel needle from T2 to T10 at midclavicular line bilaterally . Pinprick response was recorded quantitatively as 1 (sensation) or 0 (no sensation/numb). Successful block was defined as the pinprick score was 0 at 20 min after block. Otherwise, it was defined as a failed block. Receives: Procedure: Paravertebral block at T4 and T5 level | |
| Failed Paravertebral block | Pinprick test was evaluated at 20 min after Paravertebral block. Pinprick sensation was assessed using a 22-gauge short bevel needle from T2 to T10 at midclavicular line bilaterally . Pinprick response was recorded quantitatively as 1 (sensation) or 0 (no sensation/numb). Successful block was defined as the pinprick score was 0 at 20 min after block. Otherwise, it was defined as a failed block. Receives: Procedure: Paravertebral block at T4 and T5 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of skin temperature
Changes of skin temperature determined by infrared thermography
Measured: From baseline up to 20 minutes after block
Secondary outcomes (4)
Noinvasive blood pressure
Vital signs
Measured: From baseline up to 20 minutes after block
Heart rate
Vital signs
Measured: From baseline up to 20 minutes after block
SPO2
vital signs
Measured: From baseline up to 20 minutes after block
Sensory block level
Sensory block level determined by pinprick.
Measured: From baseline up to 20 minutes after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Oct 2019
- Primary completion30 Aug 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paravertebral BlockStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Wei Mei, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078347
- Sponsor's protocol ID
- TJ-IRB20190424
- Status last verified
- Nov 2020
- First submitted
- 6 Aug 2019
- Last updated
- 12 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For patient's privacy
Publications
Zhang S, Liu Y, Liu X, Liu T, Li P, Mei W. Infrared thermography for assessment of thoracic paravertebral block: a prospective observational study. BMC Anesthesiol. 2021 Jun 11;21(1):168. doi: 10.1186/s12871-021-01389-4.
PubMed 34116642
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Skin Temperature for Evaluation of Paravertebral Block: A Prospective Observational Study Using Infrared Thermography
- ClinicalTrials.gov ID
- NCT04078347
- Acronym / sponsor ID
- TJ-IRB20190424
- Conditions
- Paravertebral Block
- Keywords
- Paravertebral block, Infrared thermography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 6 Sep 2019 (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 prospective observational study was to evaluate the changes of skin temperature after the paravertebral block measured by infrared thermography.
Detailed description
Methods: Patients scheduled for elective surgery with paravertebral block will receive infrared thermography measures 5 min before the block and continous to 20 min after the block. The sensitivity, specificity of infrared thermography as diagnostic methods will be determined by receiver operator characteristic analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful Paravertebral block | – | Procedure: Paravertebral block at T4 and T5 levelPinprick test was evaluated at 20 min after Paravertebral block. Pinprick sensation was assessed using a 22-gauge short bevel needle from T2 to T10 at midclavicular line bilaterally . Pinprick response was recorded quantitatively as 1 (sensation) or 0 (no sensation/numb). Successful block was defined as the pinprick score was 0 at 20 min after block. Otherwise, it was defined as a failed block. |
| Failed Paravertebral block | – | Procedure: Paravertebral block at T4 and T5 levelPinprick test was evaluated at 20 min after Paravertebral block. Pinprick sensation was assessed using a 22-gauge short bevel needle from T2 to T10 at midclavicular line bilaterally . Pinprick response was recorded quantitatively as 1 (sensation) or 0 (no sensation/numb). Successful block was defined as the pinprick score was 0 at 20 min after block. Otherwise, it was defined as a failed block. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery with planned paravertebral block for multimodel analgesia.
Key inclusion criteria (3 listed)
- With informed consent
- American Society of Anesthesiologists physical status Ⅰ-Ⅱ
- Undergo elective surgery with planned paravertebral block
Key exclusion criteria (9 listed)
- Refusal to participate in the study
- pre-existing infection at the block site
- younger than 18-yr-old
- BMI>35
- significant thoracic kyphoscoliosis
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 |
|---|---|---|
| Paravertebral block at T4 and T5 levelParavertebral block is performed at T4 and T5 level under realtime ultrasound guidenance with 10ml of 0.5% ropivacaine for each block, respectively. | Procedure or surgery | Failed Paravertebral block, Successful Paravertebral block |
Primary outcome
Changes of skin temperature
Time frame: From baseline up to 20 minutes after block
Changes of skin temperature determined by infrared thermography
4 secondary outcomes
Noinvasive blood pressure
Time frame: From baseline up to 20 minutes after block
Heart rate
Time frame: From baseline up to 20 minutes after block
SPO2
Time frame: From baseline up to 20 minutes after block
Sensory block level
Time frame: From baseline up to 20 minutes after 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 12 Jan 2021.
- Derived from this study: PubMed 34116642Zhang S, Liu Y, Liu X, Liu T, Li P, Mei W. Infrared thermography for assessment of thoracic paravertebral block: a prospective observational study. BMC Anesthesiol. 2021 Jun 11;21(1):168. doi: 10.1186/s12871-021-01389-4.
- Individual participant dataSharing planned: No. For patient's privacy
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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.
Wei Mei principal investigator
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 Paravertebral Block, 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 9 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 12 Jan 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?
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?
Changes of skin temperature (time frame: From baseline up to 20 minutes after block). 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 NCT04078347, which also lists 1 linked publication.
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 12 Jan 2021.