Paravertebral BlockA Two-CenterNCT07021651
COMPARISON OF ERECTOR SPINA PLAN BLOCK AND THORACIC PARAVERTEBRAL BLOCK FOR PERIOPERATIVE ANALGESIA
A study testing Erector Spinae Plane (ESP) block admistring and Thoracic Paravertebral Block administring in people with Paravertebral Block, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study was to compare the postoperative analgesic efficacy of thoracic paravertebral block with erector spinae plane block, which we use in thoracotomy surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Paravertebral Block
- What is being tested?
- Erector Spinae Plane (ESP) block admistring and Thoracic Paravertebral Block administring
- Type of treatment
- Injection or infusion, 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 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who will undergo thoracotomy and are between the ages of 18-65
- have American Society of Anesthesiologists (ASA) risk classification I-II will be included in the study.
Who cannot join
- Patients who did not agree to participate in the study,
- had an infection in the application area,
- had coagulopathy,
- were morbidly obese (Body mass index (BMI)>35),
- had drug allergy,
- had chronic pain, long-term opioid use, psychiatric illness history, and required emergency surgery were excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Health Sciences University Gazi Yaşargil Training and Research Hospital
Kayapınar, Di̇yarbakir
hulyatosunsoner@hotmail.com
About this study
Official title: A Two-Center Randomized Controlled Trial
The primary aim of this study was to compare the postoperative analgesic efficacy of thoracic paravertebral block with erector spinae plane block, which we use in thoracotomy surgeries. Secondary aims were to compare these groups in terms of Riker Agitation-Sedation Scale (RASS) scores, postoperative complications, postoperative opioid consumption, and patient satisfaction.
- Conditions
- Paravertebral Block
- Being tested
- Erector Spinae Plane (ESP) block admistring, Thoracic Paravertebral Block administring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane (ESP) block admistringProcedure or surgery
In the ESPB group, the probe was placed longitudinally at the level of the T5 transverse process, 2-3 cm lateral from the midline. The muscles were visualized superior to the transverse process ; then, the needle was inserted in the craniocaudal direction using the in-plane technique. A dose of 2 mL normal saline were injected into the two layers of the interfacial area under the erector spinae muscle, and the proper injection site was confirmed. After visualizing the linear spread of saline in the fascial plane, 20 mL of 0.25% bupivacaine was injected there for the block.
Thoracic Paravertebral Block administringProcedure or surgery
In the TPVB group, the probe was placed 2-3 cm laterally and vertically of the T5 spinous process. Once the transverse process, corresponding paravertebral space, internal intercostal membrane, and pleura was identified , the needle was inserted in the lateromedial direction using the in-plane technique. After confirmation of pleural displacement with 2 mL saline, 20 mL of 0.25% bupivacaine was administered for the block.
| Study group | Role | What they receive |
|---|---|---|
| Erektor spina plan block | Active comparator | The local anesthetic is injected into the fascial plane between the erector spinae muscle and the transverse processes of the vertebrae. This allows the anesthetic to spread cranially and caudally, affecting multiple spinal nerves Receives: Procedure: Erector Spinae Plane (ESP) block admistring |
| Toracik paravertebral block | Active comparator | The local anesthetic is injected into the paravertebral space, which is bordered by the vertebral bodies, intervertebral discs, parietal pleura, and superior costotransverse ligament. This space contains the spinal nerves, sympathetic chain, and intercostal vessels Receives: Procedure: Thoracic Paravertebral Block administring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
They will be numbered from 1 to 10. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
Measured: Post-operative 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours
Secondary outcomes (3)
Riker Agitation and Sedation Scale
7 Dangerous Agitation ... If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
Measured: Immediately after extubation
Patient satisfaction score:
Patients' satisfaction with the quality of pain management will be assessed on the second postoperative day using the following scale: 1 = very dissatisfied; 2 = quite dissatisfied; 3 = moderate; 4 = quite satisfactory; 5 = very satisfactory.)
Measured: Post-operative 30 minutes
24-hour Tramadol usage:
Amount of Tramadol used per 24 hours
Measured: posoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start10 Jul 2025 (estimated)
- Primary completion20 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paravertebral BlockStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Tosun Söner, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021651
- Sponsor's protocol ID
- CEM
- Acronym
- A Two-Center
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- 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 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07021651
- Acronym / sponsor ID
- A Two-Center / CEM
- Conditions
- Paravertebral Block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 15 Jun 2025 (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 primary aim of this study was to compare the postoperative analgesic efficacy of thoracic paravertebral block with erector spinae plane block, which we use in thoracotomy surgeries. Secondary aims were to compare these groups in terms of Riker Agitation-Sedation Scale (RASS) scores, postoperative complications, postoperative opioid consumption, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erektor spina plan block | Active comparator | Procedure: Erector Spinae Plane (ESP) block admistringThe local anesthetic is injected into the fascial plane between the erector spinae muscle and the transverse processes of the vertebrae. This allows the anesthetic to spread cranially and caudally, affecting multiple spinal nerves |
| Toracik paravertebral block | Active comparator | Procedure: Thoracic Paravertebral Block administringThe local anesthetic is injected into the paravertebral space, which is bordered by the vertebral bodies, intervertebral discs, parietal pleura, and superior costotransverse ligament. This space contains the spinal nerves, sympathetic chain, and intercostal vessels |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who will undergo thoracotomy and are between the ages of 18-65
- have American Society of Anesthesiologists (ASA) risk classification I-II will be included in the study.
Key exclusion criteria (6 listed)
- Patients who did not agree to participate in the study,
- had an infection in the application area,
- had coagulopathy,
- were morbidly obese (Body mass index (BMI)>35),
- had drug allergy,
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 |
|---|---|---|
| Erector Spinae Plane (ESP) block admistringIn the ESPB group, the probe was placed longitudinally at the level of the T5 transverse process, 2-3 cm lateral from the midline. The muscles were visualized superior to the transverse process ; then, the needle was inserted in the craniocaudal direction using the in-plane technique. A dose of 2 mL normal saline were injected into the two layers of the interfacial area under the erector spinae muscle, and the proper injection site was confirmed. After visualizing the linear spread of saline in the fascial plane, 20 mL of 0.25% bupivacaine was injected there for the block. | Procedure or surgery | Erektor spina plan block |
| Thoracic Paravertebral Block administringIn the TPVB group, the probe was placed 2-3 cm laterally and vertically of the T5 spinous process. Once the transverse process, corresponding paravertebral space, internal intercostal membrane, and pleura was identified , the needle was inserted in the lateromedial direction using the in-plane technique. After confirmation of pleural displacement with 2 mL saline, 20 mL of 0.25% bupivacaine was administered for the block. | Procedure or surgery | Toracik paravertebral block |
Primary outcome
Numeric Rating Scale
Time frame: Post-operative 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours
They will be numbered from 1 to 10. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
3 secondary outcomes
Riker Agitation and Sedation Scale
Time frame: Immediately after extubation
Patient satisfaction score:
Time frame: Post-operative 30 minutes
24-hour Tramadol usage:
Time frame: posoperative 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane (ESP) block admistring and Thoracic Paravertebral Block administring in people with Paravertebral Block, run by Saglik Bilimleri Universitesi Gazi Yasargil 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 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: opening soon, as of the sponsor's last update on 15 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hülya Tosun Söner, doktor (+905352792102, hulyatosunsoner@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (time frame: Post-operative 30 minutes, 2 hours, 6 hours, 12 hours, 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 Jun 2025.