Analgesia, PostoperativeNCT03721250
Comparison of Thoracic Epidural Analgesia and Intercostal Blockade in Patients Undergoing Thoracotomy
An observational study of Analgesia, Postoperative, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain is an important issue after thoracotomy operations. Thoracic epidural analgesia is most popular analgesic method, but sometimes it is not sufficient for pain. This study is designed to compare intercostal block with thoracic epidural analgesia in patients undergoing thoracotomy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia, Postoperative
- What is being tested?
- epidural
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Dec 2018to 22 Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing thoracotomy
Who may be able to join
- lung cancer
Who cannot join
- patient refusal bleeding diathesisi emergency cases
- -
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative pain is an important issue after thoracotomy operations. Thoracic epidural analgesia is most popular analgesic method, but sometimes it is not sufficient for pain. This study is designed to compare intercostal block with thoracic epidural analgesia in patients undergoing thoracotomy
- Conditions
- Analgesia, Postoperative
- Being tested
- epidural
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epiduralOther
thoracic epidural analgesia
| Study group | Role | What they receive |
|---|---|---|
| thoracic epidural | patients receiving thoracic epidural Receives: Other: epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
verbal analog score
Measured: postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start14 Dec 2018
- Primary completion4 Mar 2019
- Study completion22 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CIGDEM YILDIRIM GUCLU, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721250
- Sponsor's protocol ID
- Ank230918
- Status last verified
- Feb 2020
- First submitted
- 23 Oct 2018
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Thoracic Epidural Analgesia and Intercostal Blockade in Patients Undergoing Thoracotomy
- ClinicalTrials.gov ID
- NCT03721250
- Acronym / sponsor ID
- Ank230918
- Conditions
- Analgesia, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 26 Oct 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.
Postoperative pain is an important issue after thoracotomy operations. Thoracic epidural analgesia is most popular analgesic method, but sometimes it is not sufficient for pain. This study is designed to compare intercostal block with thoracic epidural analgesia in patients undergoing thoracotomy
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thoracic epidural | – | Other: epiduralpatients receiving thoracic epidural |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing thoracotomy
Key inclusion criteria (1 listed)
- lung cancer
Key exclusion criteria (2 listed)
- patient refusal bleeding diathesisi emergency cases
- -
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 |
|---|---|---|
| epiduralthoracic epidural analgesia | Other | thoracic epidural |
Primary outcome
verbal analog score
Time frame: postoperative 24 hour
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 28 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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 Analgesia, Postoperative, run by Ankara University 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 1 inclusion and 2 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 28 Feb 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?
verbal analog score (time frame: postoperative 24 hour). 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 28 Feb 2020.