AnesthesiaNCT04294394
Rhomboid Block,erectör Spiane Block, Thoracotomy
An observational study of Anesthesia, run by Kocaeli Derince Education and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Effective analgesia is very important in terms of preventing respiratory, thromboembolic complications and providing early mobilization after open thoracotomy. Although thoracic epidural analgesia is gold standart method for this aim, it causes common side effects such as hypotension, dural puncture,motor block In… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- rhomboid block and erector spinae block
- How many people
- 75 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 15 Jan 2021
- How long will I take part?
- 1 Day
- 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 75 years
- All sexes
- Adult, Older adult
Study population: 18 to 75 years old patients will including in this study. Patients Asa Scores shold be ASA1,2,3
Who may be able to join
- Patients between 18-75 years old
- ASA1,2,3 group patients
- Patients undergoing thoracotomy under general anesthesia
Who cannot join
- The patient's refusal to participate in the study
- Allergy to local anesthetics
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Tahsin Şimşek
Istanbul, 34000
Derince Eğitim Ve Araştırma Hastanesi
Kocaeli, Derince, 41000
About this study
Official title: Rhomboid Block Versus Erector Spinae Block in Thoracotomy
Effective analgesia is very important in terms of preventing respiratory, thromboembolic complications and providing early mobilization after open thoracotomy.
Although thoracic epidural analgesia is gold standart method for this aim, it causes common side effects such as hypotension, dural puncture,motor block In recent years, with the effective use of ultrasonography, different regional anesthesia methods have been developed to prevent such complications
Read the detailed description
A total of 75 patients will be included in the study in three groups: group ESPB, group RIB and control group (group K). Under general anesthesia, patients who will undergo both ESPB and RIB will be applied block with a 22 G and 100 mm block needle, accompanied by ultrasonography, and 20 ml 0.25% bupivacaine. Apart from the standard peroperative analgesia protocol applied to all three groups, no additional procedure will be performed in group control. Postoperative analgesic consumption amount, first analgesic requirement time and visual analog scale (VAS) values of the patients will be recorded.
- Conditions
- Anesthesia
- Being tested
- rhomboid block, erector spinae block, control
- Keywords
- rhomboid block, erectör spinae block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhomboid blockOther
Rhombid block, on the other hand, is a method which make up analgesia by providing lokal anestethetic enjection between intercostal muscles and rhomboid muscles and blocks between t3- t9 levels
erector spinae blockOther
The Erector spinae plan block is a recently developed regional block method .Adminestering of lokal anesthetic between the transver proces and erector spinae muscles provides the dorsal and ventral branch blokades of regional spinal nerve and make up the analgesia.İt have a wide range usage such as surgery of thoracal and abdominal area
controlOther
For postoperative analgesia, all patients (including Rhomboid block and Erector spinae block) will be administered 100 mg tramadol and 1 gr paracetamol. No additional intervention other than this medical approach will be applied in the control group.
| Study group | Role | What they receive |
|---|---|---|
| rhomboid block | With a 6-13 Mhz linear USG probe, at the thoracal level of 6-7 vertebra in the sagittal position, in the cranio-caudal direction with a 22 G and 100 mm block needle in the medial of the scapula, after entering the facial plane between the rhomboid muscle and the intercostal muscle, 0.25% bupivacaine 20 ml of the local anesthetic solution will be given. Receives: Other: rhomboid block | |
| erector spinae group | After the patient is taken in the lateral position, the probe T5 is 3 cm lateral to the spinous process, 22 G and 100 mm block needle with 6-13 Mhz linear ultrasonography and the facial plane between the transverse proces and the erector spina muscle is entered, and 20 ml of a local anesthetic solution consisting of 0.25% bupivacaine will be given. Receives: Other: erector spinae block | |
| control group | For postoperative analgesia, all patients (including Rhomboid block and Erector spinae block) will be administered 100 mg tramadol and 1 gr paracetamol. No additional intervention other than this medical approach will be applied in the control group. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
rhomboid block versus erector spinae block in thorachotomy
In this study, we aimed to compare the effects of rhomboid block and erector spinae block in pain control after thoracotomy
Measured: the study will comlete in three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Feb 2020
- Primary completion5 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahsin Şimşek, Kocaeli Derince Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294394
- Sponsor's protocol ID
- 2019/514/150/22
- Status last verified
- Jan 2021
- First submitted
- 1 Mar 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhomboid Block Versus Erector Spinae Block in Thoracotomy
- ClinicalTrials.gov ID
- NCT04294394
- Acronym / sponsor ID
- 2019/514/150/22
- Conditions
- Anesthesia
- Keywords
- rhomboid block, erectör spinae block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 4 Mar 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.
Effective analgesia is very important in terms of preventing respiratory, thromboembolic complications and providing early mobilization after open thoracotomy.
Although thoracic epidural analgesia is gold standart method for this aim, it causes common side effects such as hypotension, dural puncture,motor block In recent years, with the effective use of ultrasonography, different regional anesthesia methods have been developed to prevent such complications
Detailed description
A total of 75 patients will be included in the study in three groups: group ESPB, group RIB and control group (group K). Under general anesthesia, patients who will undergo both ESPB and RIB will be applied block with a 22 G and 100 mm block needle, accompanied by ultrasonography, and 20 ml 0.25% bupivacaine. Apart from the standard peroperative analgesia protocol applied to all three groups, no additional procedure will be performed in group control. Postoperative analgesic consumption amount, first analgesic requirement time and visual analog scale (VAS) values of the patients will be recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rhomboid block | – | Other: rhomboid blockWith a 6-13 Mhz linear USG probe, at the thoracal level of 6-7 vertebra in the sagittal position, in the cranio-caudal direction with a 22 G and 100 mm block needle in the medial of the scapula, after entering the facial plane between the rhomboid muscle and the intercostal muscle, 0.25% bupivacaine 20 ml of the local anesthetic solution will be given. |
| erector spinae group | – | Other: erector spinae blockAfter the patient is taken in the lateral position, the probe T5 is 3 cm lateral to the spinous process, 22 G and 100 mm block needle with 6-13 Mhz linear ultrasonography and the facial plane between the transverse proces and the erector spina muscle is entered, and 20 ml of a local anesthetic solution consisting of 0.25% bupivacaine will be given. |
| control group | – | Other: controlFor postoperative analgesia, all patients (including Rhomboid block and Erector spinae block) will be administered 100 mg tramadol and 1 gr paracetamol. No additional intervention other than this medical approach will be applied in the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 18 to 75 years old patients will including in this study. Patients Asa Scores shold be ASA1,2,3
Key inclusion criteria (3 listed)
- Patients between 18-75 years old
- ASA1,2,3 group patients
- Patients undergoing thoracotomy under general anesthesia
Key exclusion criteria (2 listed)
- The patient's refusal to participate in the study
- Allergy to local anesthetics
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 blockRhombid block, on the other hand, is a method which make up analgesia by providing lokal anestethetic enjection between intercostal muscles and rhomboid muscles and blocks between t3- t9 levels | Other | rhomboid block |
| erector spinae blockThe Erector spinae plan block is a recently developed regional block method .Adminestering of lokal anesthetic between the transver proces and erector spinae muscles provides the dorsal and ventral branch blokades of regional spinal nerve and make up the analgesia.İt have a wide range usage such as surgery of thoracal and abdominal area | Other | erector spinae group |
| controlFor postoperative analgesia, all patients (including Rhomboid block and Erector spinae block) will be administered 100 mg tramadol and 1 gr paracetamol. No additional intervention other than this medical approach will be applied in the control group. | Other | control group |
Primary outcome
rhomboid block versus erector spinae block in thorachotomy
Time frame: the study will comlete in three month
In this study, we aimed to compare the effects of rhomboid block and erector spinae block in pain control after thoracotomy
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 3 Feb 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Kocaeli Derince Education and Research Hospital at 2 sites 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 3 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
rhomboid block versus erector spinae block in thorachotomy (time frame: the study will comlete in three month). 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 3 Feb 2021; AzTrials last refreshed its copy on 1 Nov 2026.