Postoperative AnalgesiaNCT06260137
Comparison of Two Different Methods for Reducing Pain After Lung Surgery
A study testing Rhomboid intercostal block and Rhomboid intercostal and subserratus plane block in people with Postoperative Analgesia, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical study is to compare the effectiveness of the Rhomboid Intercostal Block and Sub-Servitus plan block and the effectiveness of the Rhomboid intercostal block in patients with video-supported thoracoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Rhomboid intercostal block and Rhomboid intercostal and subserratus plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2023to Aug 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in American Society of Anesthesiologists (ASA) classes I, II and III for whom VATS is planned
Who cannot join
- Known or suspected local anesthetic allergy
- coagulopathy
- injection site infection
- history of thoracic surgery
- serious neurological or psychiatric disorder
- severe cardiovascular disease
- liver failure
- renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of the Combination of Rhomboid Intercostal and Sub-serratus Plan Block and Rhomboid Intercostal Block for Postoperative Analgesis in Video-assisted Thoracopic Surgery (VATS)
The goal of this clinical study is to compare the effectiveness of the Rhomboid Intercostal Block and Sub-Servitus plan block and the effectiveness of the Rhomboid intercostal block in patients with video-supported thoracoscopic surgery. The main question it aims to answer is:
Which of these two blocks more effectively reduces the patients' pain?
- Conditions
- Postoperative Analgesia
- Being tested
- Rhomboid intercostal block, Rhomboid intercostal and subserratus plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhomboid intercostal blockProcedure or surgery
Patients will be injected with a local anesthetic drug under the rhomboid intercostal muscle before surgery.
Rhomboid intercostal and subserratus plane blockProcedure or surgery
Patients will be injected with a local anesthetic drug under the rhomboid intercostal muscle and the serrates anterior muscle before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Rhomboid İntercostal Block (RIB) | Active comparator | Not described Receives: Procedure: Rhomboid intercostal block |
| Rhomboid intercostal and subserratus plane block (RISS) | Active comparator | Not described Receives: Procedure: Rhomboid intercostal and subserratus plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia
Patients' VAS scores and additional analgesic needs in the first 48 hours will be evaluated. VAS (visual pain scale) corresponds to a value between 0 and 10. A value of 0 means no pain, and a value of 10 is the most severe pain.
Measured: first 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start10 Jul 2023
- Primary completionJul 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferhat Ustuner, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260137
- Sponsor's protocol ID
- UludagThorax
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of the Combination of Rhomboid Intercostal and Sub-serratus Plan Block and Rhomboid Intercostal Block for Postoperative Analgesis in Video-assisted Thoracopic Surgery (VATS)
- ClinicalTrials.gov ID
- NCT06260137
- Acronym / sponsor ID
- UludagThorax
- Conditions
- Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 15 Feb 2024 (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 clinical study is to compare the effectiveness of the Rhomboid Intercostal Block and Sub-Servitus plan block and the effectiveness of the Rhomboid intercostal block in patients with video-supported thoracoscopic surgery. The main question it aims to answer is:
Which of these two blocks more effectively reduces the patients' pain?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhomboid İntercostal Block (RIB) | Active comparator | Procedure: Rhomboid intercostal block |
| Rhomboid intercostal and subserratus plane block (RISS) | Active comparator | Procedure: Rhomboid intercostal and subserratus plane block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in American Society of Anesthesiologists (ASA) classes I, II and III for whom VATS is planned
Key exclusion criteria (8 listed)
- Known or suspected local anesthetic allergy
- coagulopathy
- injection site infection
- history of thoracic surgery
- serious neurological or psychiatric disorder
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 |
|---|---|---|
| Rhomboid intercostal blockPatients will be injected with a local anesthetic drug under the rhomboid intercostal muscle before surgery. | Procedure or surgery | Rhomboid İntercostal Block (RIB) |
| Rhomboid intercostal and subserratus plane blockPatients will be injected with a local anesthetic drug under the rhomboid intercostal muscle and the serrates anterior muscle before surgery. | Procedure or surgery | Rhomboid intercostal and subserratus plane block (RISS) |
Primary outcome
Postoperative analgesia
Time frame: first 48 hours postoperatively
Patients' VAS scores and additional analgesic needs in the first 48 hours will be evaluated. VAS (visual pain scale) corresponds to a value between 0 and 10. A value of 0 means no pain, and a value of 10 is the most severe pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- 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?
A study testing Rhomboid intercostal block and Rhomboid intercostal and subserratus plane block in people with Postoperative Analgesia, run by Uludag 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 8 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 15 Feb 2024. 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?
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?
Postoperative analgesia (time frame: first 48 hours postoperatively). 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 15 Feb 2024.