Pain, PostoperativeNCT04929665
Thoracic Paravertebral Block, Erector Spinae Plane Block, and in Combined Paravertebral-erector Spinae Block
A study testing Two different block and combination of these two blocks in people with Pain, Postoperative and Thoracic Surgery, Video-Assisted, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Thoracic Surgery, Video-Assisted, Thoracic Paravertebral Block
- What is being tested?
- Two different block and combination of these two blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 13 Jul 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years old
- ASA physical status I-II-III
- BMI 18 to 30 kg/m2
- Elective video assisted thoracoscopic surgery
Who cannot join
- Patient refusing the procedure
- Emergency surgery
- Chronic opioid or analgesic use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
Keçiören, Ankara, 06000
About this study
Official title: Comparison of Ultrasound-guided Thoracic Paravertebral and Erector Spinae Plane Block Alone and in Combination on Analgesia After Video-assisted Thoracoscopic Surgery
Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. Generally, comparisons are made between ESPB and TPVB in studies and the analgesic effect is evaluated. However, no research could be found in the literature combining ESPB and TPVB. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of TPVB and ESPB, as in the multimodal analgesia method. This study seeks to evaluate the effect of TPVB, ESPB and combined TPVB-ESPB pain after VATS.
- Conditions
- Pain, Postoperative, Thoracic Surgery, Video-Assisted, Thoracic Paravertebral Block, Erector Spinae Plane Block
- Being tested
- Two different block and combination of these two blocks
- Keywords
- Erector spinae block, Thoracic paravertebral block, VATS
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two different block and combination of these two blocksProcedure or surgery
Thoracic paravertebral block, erector spina block, and a combination of paravertebral block and erector spinae block will be applied to the patients under real-time ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Paravertebral Block | Active comparator | In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 20 ml of 0.25% bupivacaine will be injected into this area. Receives: Procedure: Two different block and combination of these two blocks |
| Erector spinae block | Active comparator | Patients who are planned to have an erector spina block will be advanced to the interfacial area under the erector spinae muscle by ultrasound-guided in-plane technique. 20 ml of 0.25% bupivacaine will be injected into this area. Receives: Procedure: Two different block and combination of these two blocks |
| Thoracic Paravertebral block and Erector spinae Block | Active comparator | In patients who are planned to have combined erector spinae block and thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 10 ml of 0.25% bupivacaine will be given to this area. Then, with the same needle, return 1-2 cm from the paravertebral area and inject 10 ml of 0.25% bupivacaine into the interfacial area under the erector spinae muscle. Receives: Procedure: Two different block and combination of these two blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores [ Time Frame: 24 hours after the surgery]
Pain will be assessed at rest and on coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th and 24th hours after surgery.
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 posted18 Jun 2021
- Study start1 Apr 2021
- Primary completion1 Jul 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Zengin, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Investigators
- Musa Zengin, MD, Principal investigator, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929665
- Sponsor's protocol ID
- E.Kurul-E1-21-1688
- Status last verified
- Jul 2021
- First submitted
- 10 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-guided Thoracic Paravertebral and Erector Spinae Plane Block Alone and in Combination on Analgesia After Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT04929665
- Acronym / sponsor ID
- E.Kurul-E1-21-1688
- Conditions
- Pain, Postoperative, Thoracic Surgery, Video-Assisted, Thoracic Paravertebral Block, Erector Spinae Plane Block
- Keywords
- Erector spinae block, Thoracic paravertebral block, VATS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 18 Jun 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.
Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. Generally, comparisons are made between ESPB and TPVB in studies and the analgesic effect is evaluated. However, no research could be found in the literature combining ESPB and TPVB. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of TPVB and ESPB, as in the multimodal analgesia method. This study seeks to evaluate the effect of TPVB, ESPB and combined TPVB-ESPB pain after VATS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thoracic Paravertebral Block | Active comparator | Procedure: Two different block and combination of these two blocksIn patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 20 ml of 0.25% bupivacaine will be injected into this area. |
| Erector spinae block | Active comparator | Procedure: Two different block and combination of these two blocksPatients who are planned to have an erector spina block will be advanced to the interfacial area under the erector spinae muscle by ultrasound-guided in-plane technique. 20 ml of 0.25% bupivacaine will be injected into this area. |
| Thoracic Paravertebral block and Erector spinae Block | Active comparator | Procedure: Two different block and combination of these two blocksIn patients who are planned to have combined erector spinae block and thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 10 ml of 0.25% bupivacaine will be given to this area. Then, with the same needle, return 1-2 cm from the paravertebral area and inject 10 ml of 0.25% bupivacaine into the interfacial area under the erector spinae muscle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 80 years old
- ASA physical status I-II-III
- BMI 18 to 30 kg/m2
- Elective video assisted thoracoscopic surgery
Key exclusion criteria (3 listed)
- Patient refusing the procedure
- Emergency surgery
- Chronic opioid or analgesic use
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 |
|---|---|---|
| Two different block and combination of these two blocksThoracic paravertebral block, erector spina block, and a combination of paravertebral block and erector spinae block will be applied to the patients under real-time ultrasound guidance. | Procedure or surgery | Erector spinae block, Thoracic Paravertebral Block, Thoracic Paravertebral block and Erector spinae Block |
Primary outcome
Pain scores [ Time Frame: 24 hours after the surgery]
Time frame: 24 hours
Pain will be assessed at rest and on coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th and 24th hours after surgery.
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 15 Jul 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.
Musa Zengin, MD principal investigator
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two different block and combination of these two blocks in people with Pain, Postoperative and Thoracic Surgery, Video-Assisted, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital 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 4 inclusion and 3 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 15 Jul 2021. 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 [ Time Frame: 24 hours after the surgery] (time frame: 24 hours). 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 Jul 2021.