Visual Analogy ScalaNCT04765579
Investigation of the Effect of 4 in 1 Block Application on Postoperative Analgesia in Knee Surgeries.
An observational study of Visual Analogy Scala, run by Derince Training and Research Hospital.
Trial summary
to investigate the effects of ultrasonography-guided 4in1 block application on postoperative analgesia in patients undergoing knee surgery. After knee surgeries performed with spinal anesthesia, 4in1 block will be applied in one group and medical analgesics will be applied in the service in the other group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visual Analogy Scala
- What is being tested?
- visual analogy scala
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2021to 20 Aug 2021
- 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 years and older
- All sexes
- Adult, Older adult
Study population: knee surgeries performed with spinal anesthesia
Who may be able to join
- ASA I-II
- 18-60 ages
- who were informed about the study and accepted,
- who underwent knee surgery
Who cannot join
- ASA III-IV
- who are under general anesthesia
- who do not agree to participate in the study
- who are urgently operated
About this study
Official title: Effects of Ultrasonography-guided 4in1 Block Application on Postoperative Analgesia in Patients Undergoing Knee Surgery
to investigate the effects of ultrasonography-guided 4in1 block application on postoperative analgesia in patients undergoing knee surgery. After knee surgeries performed with spinal anesthesia, 4in1 block will be applied in one group and medical analgesics will be applied in the service in the other group.
- Conditions
- Visual Analogy Scala
- Being tested
- visual analogy scala
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual analogy scalaBehavioural
We will investigate the effect of 4in1 block by questioning the vas score of the patients, its effect on quadriceps strength, and additional analgesia needs for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| 4in1 | 4in1 block will be applied in the operation room Receives: Behavioral: visual analogy scala | |
| medical | medical analgesics will be applied in the service Receives: Behavioral: visual analogy scala |
What is being measured
The primary outcome is the main question the study is designed to answer.
visuel analogue scale
0:No pain, 10:Very severe pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start20 Feb 2021 (estimated)
- Primary completion20 Jul 2021 (estimated)
- Study completion20 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Analogy ScalaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyran Köksal, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765579
- Sponsor's protocol ID
- Seyran-Tez
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 21 Feb 2021
- 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 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasonography-guided 4in1 Block Application on Postoperative Analgesia in Patients Undergoing Knee Surgery
- ClinicalTrials.gov ID
- NCT04765579
- Acronym / sponsor ID
- Seyran-Tez
- Conditions
- Visual Analogy Scala
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Feb 2021 (estimated)
- Primary completion
- 20 Jul 2021 (estimated)
- Study completion
- 20 Aug 2021 (estimated)
- First posted
- 21 Feb 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.
to investigate the effects of ultrasonography-guided 4in1 block application on postoperative analgesia in patients undergoing knee surgery. After knee surgeries performed with spinal anesthesia, 4in1 block will be applied in one group and medical analgesics will be applied in the service in the other group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4in1 | – | Behavioral: visual analogy scala4in1 block will be applied in the operation room |
| medical | – | Behavioral: visual analogy scalamedical analgesics will be applied in the service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- knee surgeries performed with spinal anesthesia
Key inclusion criteria (4 listed)
- ASA I-II
- 18-60 ages
- who were informed about the study and accepted,
- who underwent knee surgery
Key exclusion criteria (4 listed)
- ASA III-IV
- who are under general anesthesia
- who do not agree to participate in the study
- who are urgently operated
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 |
|---|---|---|
| visual analogy scalaWe will investigate the effect of 4in1 block by questioning the vas score of the patients, its effect on quadriceps strength, and additional analgesia needs for 24 hours. | Behavioural | 4in1, medical |
Primary outcome
visuel analogue scale
Time frame: 6 months
0:No pain, 10:Very severe pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Analogy Scala, run by Derince Training and Research 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 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 21 Feb 2021. 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?
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?
visuel analogue scale (time frame: 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 21 Feb 2021.