Postoperative PainNCT04235530
Comparison of Ultrasonography Guided Serratus Anterior Plane Block and Thoracic Paravertebral Block in Thoracic Surgery
An observational study of Postoperative Pain, run by Merve Sena BAYTAR at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is comparison of the effectiveness of ultrasound guided serratus anterior plane block and thoracic paravertebral block as a preventive analgesia method after VATS. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- How many people
- 5 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2018to 1 Feb 2019
- How long will I take part?
- 2 Days
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: who underwent elective video-assisted thoracoscopic surgery
Who may be able to join
- aged between 18 and 65 years
- ASA (American Society of Anesthesiologists) score I-II
Who cannot join
- inability to communicate
- body mass index (BMI) > 35 kg/m2
- infection in the area where the block was to be applied
- allergy to the drugs used
- mentally impaired
- bleeding impaired
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Education and Research Hospital
Bursa, 16600
About this study
Official title: Comparison of Ultrasonography Guided Serratus Anterior Plane Block and Thoracic Paravertebral Block in Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Double-blind Study
The aim of this study is comparison of the effectiveness of ultrasound guided serratus anterior plane block and thoracic paravertebral block as a preventive analgesia method after VATS. Our secondary aim is to investigate patient and surgeon satisfaction, duration of block application, postoperative complications and hospital lenght of stay.
- Conditions
- Postoperative Pain
- Keywords
- thoracoscopic surgery video assisted, serratus anterior, paravertebral block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VAS and DVAS | To measure the pain score of patients after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores in rest and coughing
Pain scores observed after surgery at 0, 1 ,2 ,6 ,12 ,24 th hours by visual analog scale. We assessed pain scores both in rest and coughing. This scale scores pain from 0 to 10. 0 means no pain and 10 means unbearable pain.
Measured: 24 hours
consumption of opioids
We observed how much opioid ( how many miligrams) the patient consumed in 24 hours postoperatively with pca device.
Measured: 24 hours
Secondary outcomes (2)
postoperative complications
we compare postoperative complications like nausea, vomiting, constipation, pruritus first 24 hours after surgery.
Measured: 24 hours
lenght of hospital stay
we compared how many days the patients stayed in the hospital until discharge
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start15 Apr 2018
- Primary completion15 Oct 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- 5 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Merve Sena BAYTAR
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Merve Sena BAYTAR, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235530
- Sponsor's protocol ID
- 2018-7/27
- Status last verified
- Jan 2020
- First submitted
- 13 Jan 2020
- Last updated
- 22 Jan 2020
- 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 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasonography Guided Serratus Anterior Plane Block and Thoracic Paravertebral Block in Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT04235530
- Acronym / sponsor ID
- 2018-7/27
- Conditions
- Postoperative Pain
- Keywords
- thoracoscopic surgery video assisted, serratus anterior, paravertebral block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Merve Sena BAYTAROther government
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 22 Jan 2020 (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 comparison of the effectiveness of ultrasound guided serratus anterior plane block and thoracic paravertebral block as a preventive analgesia method after VATS. Our secondary aim is to investigate patient and surgeon satisfaction, duration of block application, postoperative complications and hospital lenght of stay.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAS and DVAS | – | –To measure the pain score of patients after surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- who underwent elective video-assisted thoracoscopic surgery
Key inclusion criteria (2 listed)
- aged between 18 and 65 years
- ASA (American Society of Anesthesiologists) score I-II
Key exclusion criteria (6 listed)
- inability to communicate
- body mass index (BMI) > 35 kg/m2
- infection in the area where the block was to be applied
- allergy to the drugs used
- mentally impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pain scores in rest and coughing
Time frame: 24 hours
Pain scores observed after surgery at 0, 1 ,2 ,6 ,12 ,24 th hours by visual analog scale. We assessed pain scores both in rest and coughing. This scale scores pain from 0 to 10. 0 means no pain and 10 means unbearable pain.
consumption of opioids
Time frame: 24 hours
We observed how much opioid ( how many miligrams) the patient consumed in 24 hours postoperatively with pca device.
2 secondary outcomes
postoperative complications
Time frame: 24 hours
lenght of hospital stay
Time frame: 48 hours
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 22 Jan 2020.
- 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.
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 Postoperative Pain, run by Merve Sena BAYTAR at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 22 Jan 2020. 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 Turkey (Türkiye). 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?
pain scores in rest and coughing (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 22 Jan 2020.