Venous Cannulation PainNCT06002724
Feasibility Study of Peripheral Venous Cannulation Pain in Predicting Acute Pain After Total Knee Arthroplasty
An observational study of Venous Cannulation Pain and Total Knee Arthroplasty, run by RenJi Hospital.
Trial summary
The goal of this prospective observational study is to explore the feasibility of preoperative peripheral venous cannulation pain score in predicting acute pain after total knee arthroplasty, including resting pain and movement-evoked pain. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Cannulation Pain, Total Knee Arthroplasty, Movement-evoked Pain
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2023to 30 Aug 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing unilateral total knee arthroplasty for the first time under general anesthesia combined with nerve block
Who may be able to join
- Patients undergoing the first unilateral total knee arthroplasty surgery under general anesthesia combined with nerve block ;
- Age : 18 years old ≤ age ≤ 80 years old ;
- ASA grade I-II ;
- Informed consent was signed by patients or immediate family members before operation.
Who cannot join
- There are known pain abnormalities, mental disorders, cognitive dysfunction ;
- patients with long-term use of opioids and a history of drug dependence ;
- patients with alcohol dependence ;
- the patient refused to use the analgesic pump ;
- Difficult to understand the VAS score ;
- body mass index ≥ 40 ;
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- hand nerve abnormalities, hand loss ;
- plan postoperative ICU patients ;
- In other cases, the researchers believe that is not suitable for this researcher.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility Study of Peripheral Venous Cannulation Pain in Predicting Acute Pain After
The goal of this prospective observational study is to explore the feasibility of preoperative peripheral venous cannulation pain score in predicting acute pain after total knee arthroplasty, including resting pain and movement-evoked pain.
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| 0 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative resting pain and movement-evoked pain
visual analogue scale（VAS) of one hour、the first day and the second day after operation
Measured: one hour、the first day and the second day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start30 Aug 2023 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Cannulation PainStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002724
- Sponsor's protocol ID
- taoliqin0730
- Status last verified
- Sep 2023
- First submitted
- 16 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- 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 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Peripheral Venous Cannulation Pain in Predicting Acute Pain After
- ClinicalTrials.gov ID
- NCT06002724
- Acronym / sponsor ID
- taoliqin0730
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 21 Aug 2023 (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 goal of this prospective observational study is to explore the feasibility of preoperative peripheral venous cannulation pain score in predicting acute pain after total knee arthroplasty, including resting pain and movement-evoked pain.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0 | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing unilateral total knee arthroplasty for the first time under general anesthesia combined with nerve block
Key inclusion criteria (4 listed)
- Patients undergoing the first unilateral total knee arthroplasty surgery under general anesthesia combined with nerve block ;
- Age : 18 years old ≤ age ≤ 80 years old ;
- ASA grade I-II ;
- Informed consent was signed by patients or immediate family members before operation.
Key exclusion criteria (9 listed)
- There are known pain abnormalities, mental disorders, cognitive dysfunction ;
- patients with long-term use of opioids and a history of drug dependence ;
- patients with alcohol dependence ;
- the patient refused to use the analgesic pump ;
- Difficult to understand the VAS score ;
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 |
|---|---|---|
| Other | 0 |
Primary outcome
postoperative resting pain and movement-evoked pain
Time frame: one hour、the first day and the second day after operation
visual analogue scale（VAS) of one hour、the first day and the second day after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Cannulation Pain and Total Knee Arthroplasty, run by RenJi Hospital.
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 4 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: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Liqin Tao (18020264650, 1349468702@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative resting pain and movement-evoked pain (time frame: one hour、the first day and the second day after operation). 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 7 Sep 2023.