Postoperative PainNCT05061667
Thoracic Paravertebral Block Versus Rhomboid Block for Postoperative Pain Control in Thoracic Surgeries
A study testing Thoracic Paravertebral Block and Rhomboid Block in people with Postoperative Pain, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The main aim of this study is to compare thoracic paravertebral block and rhomboid block for postoperative analgesia and analgesic usage in thoracic surgeries. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Thoracic Paravertebral Block and Rhomboid Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 15 Dec 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for general thoracic surgery
- ASA I-III
Who cannot join
- Patients without consent
- Emergency surgeries
- Pregnancy
- Coagulopathies and bleeding diathesis
- Allergy to local anesthetics
- Local skin infection at the puncture site
Trial locations and contacts
1 site in 1 country.
About this study
The main aim of this study is to compare thoracic paravertebral block and rhomboid block for postoperative analgesia and analgesic usage in thoracic surgeries.
Read the detailed description
Patients with scheduled thoracic surgery are going to be enrolled for this study. Patients will be randomized and separated in two groups. Group I will receive thoracic paravertebral block, group II will receive rhomboid block. Each group will receive patient controlled analgesia with intravenous fentanyl. Patients will be monitored at postoperative 1st, 3rd, 6th, 12th, 24th hours and their VAS scores, adverse reactions like nausea and vomiting, total analgesic usage, additional analgesic need and time of the first report of pain will be filed. Then the two groups will be compared and evaluated.
- Conditions
- Postoperative Pain
- Being tested
- Thoracic Paravertebral Block, Rhomboid Block
- Keywords
- Thoracic surgery, Postoperative pain, Rhomboid block, 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.
Thoracic Paravertebral BlockProcedure or surgery
Also called TPVB
Paravertebral block for postoperative analgesia in thoracic surgery
Rhomboid BlockProcedure or surgery
Rhomboid block for postoperative analgesia in thoracic surgery
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Group I will consist of randomly assigned patients scheduled for thoracic surgery. These patients will recieve paravertebral block which is already proven to be effective in postoperative pain. After applying standart monitors to the patient and proper positioning in the operating room, paravertebral block will be performed at the planned surgical side using high frequency (8-18 MHz) linear probe of GE Logiq S7 (General Electric Healthcare, Little Chalfont, United Kingdom). 20 ml of 0.25% bupivacaine will be administered into the paravertebral space at T5-T6 vertebra levels using a 50 mm 22 G block needle (BBraun, Melsungen, Germany). Receives: Procedure: Thoracic Paravertebral Block |
| Group II | Experimental | Group II will consist of randomly assigned patients scheduled for thoracic surgery. These patients will recieve rhomboid block which is being experimented for its efficacy in postoperative pain. After applying standart monitors to the patient and proper positioning in the operating room, rhomboid block will be performed at the planned surgical side using high frequency (8-18 MHz) linear probe of GE Logiq S7 (General Electric Healthcare, Little Chalfont, United Kingdom). 20 ml of 0.25% bupivacaine will be administered into the plane between rhomboid muscle and intercostal muscles, medial to scapula at T5-T6 vertebra levels using a 50 mm 22 G block needle (BBraun, Melsungen, Germany). Receives: Procedure: Rhomboid Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Visual Analogue Scale (VAS) scores between two groups
Statistically significant difference in VAS scores at 1st, 3rd, 6th, 12th, 24th hours between two groups. On a scale of 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.
Measured: 24 hours
Difference in additional analgesic usage between two groups
Intravenous patient controlled analgesia usage and additional analgesic dosages will be filed as miligrams or micrograms at 1st, 3rd, 6th, 12th, 24th hours.
Measured: 24 hours
Secondary outcomes (2)
Incidence of nausea and vomiting
Incidence of symptoms like nausea and vomiting will be filed at 1st, 3rd, 6th, 12th, 24th hours. On a scale of 0 to 1, where 0 means no symptoms and 1 means nausea and vomiting.
Measured: 24 hours
Patient satisfaction
Patient will be reevaluated at 24th hour for analgesic satisfaction. On a scale of 0 to 3, where 0 means not satisfied and 3 means satisfied.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Jan 2021
- Primary completion1 Nov 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061667
- Sponsor's protocol ID
- 2021.066.IRB1.022
- Status last verified
- May 2021
- First submitted
- 22 Sep 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected for the study, including de-identified individual participant data will be made available to other within 6 months after the publication of this trial, as will additional related documents (study protocol, statistical analysis plan and informed consent form), for academic purposes (e.g., meta-analyses), upon request to the corresponding author, and with a signed data access agreement.
Publications
Ciftci B, Ekinci M, Atalay YO. Ultrasound-guided rhomboid intercostal block provides effective pain control after video-assisted thoracoscopic surgery: a brief report of three cases. Korean J Anesthesiol. 2021 Aug;74(4):355-357. doi: 10.4097/kja.20538. Epub 2020 Nov 17. No abstract available.
PubMed 33198430Longo F, Piliego C, Martuscelli M, Tomaselli E, Crucitti P, Longo F, Agro FE. Rhomboid intercostal and subserratus plane block for intubated uniportal video-assisted thoracoscopic surgery lobectomy. J Clin Anesth. 2020 Oct;65:109881. doi: 10.1016/j.jclinane.2020.109881. Epub 2020 May 26. No abstract available.
PubMed 32470838Longo F, Piliego C. Rhomboid intercostal and subserratus plane block for non-intubated video-assisted thoracoscopic surgery. J Clin Anesth. 2020 May;61:109612. doi: 10.1016/j.jclinane.2019.09.006. Epub 2019 Oct 24. No abstract available.
PubMed 31668692
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Paravertebral Block Versus Rhomboid Block for Postoperative Pain Control in Thoracic Surgeries
- ClinicalTrials.gov ID
- NCT05061667
- Acronym / sponsor ID
- 2021.066.IRB1.022
- Conditions
- Postoperative Pain
- Keywords
- Thoracic surgery, Postoperative pain, Rhomboid block, Paravertebral block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 29 Sep 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.
The main aim of this study is to compare thoracic paravertebral block and rhomboid block for postoperative analgesia and analgesic usage in thoracic surgeries.
Detailed description
Patients with scheduled thoracic surgery are going to be enrolled for this study. Patients will be randomized and separated in two groups. Group I will receive thoracic paravertebral block, group II will receive rhomboid block. Each group will receive patient controlled analgesia with intravenous fentanyl. Patients will be monitored at postoperative 1st, 3rd, 6th, 12th, 24th hours and their VAS scores, adverse reactions like nausea and vomiting, total analgesic usage, additional analgesic need and time of the first report of pain will be filed. Then the two groups will be compared and evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: Thoracic Paravertebral BlockGroup I will consist of randomly assigned patients scheduled for thoracic surgery. These patients will recieve paravertebral block which is already proven to be effective in postoperative pain. After applying standart monitors to the patient and proper positioning in the operating room, paravertebral block will be performed at the planned surgical side using high frequency (8-18 MHz) linear probe of GE Logiq S7 (General Electric Healthcare, Little Chalfont, United Kingdom). 20 ml of 0.25% bupivacaine will be administered into the paravertebral space at T5-T6 vertebra levels using a 50 mm 22 G block needle (BBraun, Melsungen, Germany). |
| Group II | Experimental | Procedure: Rhomboid BlockGroup II will consist of randomly assigned patients scheduled for thoracic surgery. These patients will recieve rhomboid block which is being experimented for its efficacy in postoperative pain. After applying standart monitors to the patient and proper positioning in the operating room, rhomboid block will be performed at the planned surgical side using high frequency (8-18 MHz) linear probe of GE Logiq S7 (General Electric Healthcare, Little Chalfont, United Kingdom). 20 ml of 0.25% bupivacaine will be administered into the plane between rhomboid muscle and intercostal muscles, medial to scapula at T5-T6 vertebra levels using a 50 mm 22 G block needle (BBraun, Melsungen, Germany). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for general thoracic surgery
- ASA I-III
Key exclusion criteria (6 listed)
- Patients without consent
- Emergency surgeries
- Pregnancy
- Coagulopathies and bleeding diathesis
- 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 |
|---|---|---|
| Thoracic Paravertebral BlockAlso: TPVBParavertebral block for postoperative analgesia in thoracic surgery | Procedure or surgery | Group I |
| Rhomboid BlockRhomboid block for postoperative analgesia in thoracic surgery | Procedure or surgery | Group II |
Primary outcome
Difference in Visual Analogue Scale (VAS) scores between two groups
Time frame: 24 hours
Statistically significant difference in VAS scores at 1st, 3rd, 6th, 12th, 24th hours between two groups. On a scale of 0 to 10, where 0 means no pain and 10 means the worst imaginable pain.
Difference in additional analgesic usage between two groups
Time frame: 24 hours
Intravenous patient controlled analgesia usage and additional analgesic dosages will be filed as miligrams or micrograms at 1st, 3rd, 6th, 12th, 24th hours.
2 secondary outcomes
Incidence of nausea and vomiting
Time frame: 24 hours
Patient satisfaction
Time frame: 24 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 20 Jan 2022.
- Background: PubMed 33198430Ciftci B, Ekinci M, Atalay YO. Ultrasound-guided rhomboid intercostal block provides effective pain control after video-assisted thoracoscopic surgery: a brief report of three cases. Korean J Anesthesiol. 2021 Aug;74(4):355-357. doi: 10.4097/kja.20538. Epub 2020 Nov 17. No abstract available.
- Background: PubMed 32470838Longo F, Piliego C, Martuscelli M, Tomaselli E, Crucitti P, Longo F, Agro FE. Rhomboid intercostal and subserratus plane block for intubated uniportal video-assisted thoracoscopic surgery lobectomy. J Clin Anesth. 2020 Oct;65:109881. doi: 10.1016/j.jclinane.2020.109881. Epub 2020 May 26. No abstract available.
- Background: PubMed 31668692Longo F, Piliego C. Rhomboid intercostal and subserratus plane block for non-intubated video-assisted thoracoscopic surgery. J Clin Anesth. 2020 May;61:109612. doi: 10.1016/j.jclinane.2019.09.006. Epub 2019 Oct 24. No abstract available.
- Individual participant dataSharing planned: Yes. Data collected for the study, including de-identified individual participant data will be made available to other within 6 months after the publication of this trial, as will additional related documents (study protocol, statistical analysis plan and informed consent form), for academic purposes (e.g., meta-analyses), upon request to the corresponding author, and with a signed data access agreement.
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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 Thoracic Paravertebral Block and Rhomboid Block in people with Postoperative Pain, run by Koç 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 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 20 Jan 2022. 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?
Difference in Visual Analogue Scale (VAS) scores between two groups (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?
On the ClinicalTrials.gov record for NCT05061667, which also lists 3 linked publications.
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 20 Jan 2022.