Thoracic Paravertebral BlockNCT05700357
Different Local Anesthetic Volumes for TPVB in Post-thoracotomy Analgesia
A study testing TPVB with 20 ml, TPVB with 25 ml and TPVB with 30 ml in people with Thoracic Paravertebral Block and Thoracotomy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Thoracotomy is one of the most painful operations known. Therefore, it causes severe acute pain. If pain is not controlled, it increases the frequency of postoperative pulmonary complications and postoperative morbidity. It can even cause chronic pain in the future. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracic Paravertebral Block, Thoracotomy, Postoperative Analgesia
- What is being tested?
- TPVB with 20 ml, TPVB with 25 ml and TPVB with 30 ml
- 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
- 28 Dec 2022to 28 Dec 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
- 18 to 80 years old
- American Society of Anesthesiologists (ASA) physical status I-II-III
- BMI 18 to 40 kg/m2
- Elective thoracotomy surgery
Who cannot join
- Patient refusing the procedure
- Emergency surgery
- History of chronic opioid or analgesic used
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital
Çankaya, Ankara, 06290
Emine N Zengin, MD, +905063370548, nilbavullu@gmail.com
About this study
Official title: Comparison of Different Local Anesthetic Volumes of Thoracic Paravertebral Block Application in Post-thoracotomy Analgesia
Thoracotomy is one of the most painful operations known. Therefore, it causes severe acute pain. If pain is not controlled, it increases the frequency of postoperative pulmonary complications and postoperative morbidity. It can even cause chronic pain in the future. Thoracic epidural analgesia (TEA) is the gold standard method in the treatment of pain after thoracotomy. Thoracic paravertebral block (TPVB) is known as the most effective method after TEA. The fact that TPVB has fewer side effects than TEA increases the use of TPVB. There is no consensus on the dose of analgesia in studies. In the literature, volumes between 20 ml and 30 ml are frequently used for TPVB in recent years. This study, it was aimed to compare the efficacy of 20 ml, 25 ml, and 30 ml volumes of TPVB with local anesthetic at the same concentration (0.25% bupivacaine) on postoperative analgesia in patients undergoing thoracotomy.
- Conditions
- Thoracic Paravertebral Block, Thoracotomy, Postoperative Analgesia, Acute Pain, Local Anesthetic
- Being tested
- TPVB with 20 ml, TPVB with 25 ml, TPVB with 30 ml
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPVB with 20 mlProcedure or surgery
The thoracic paravertebral block will be applied to the patients with 20 ml of 0.25% bupivacaine under real-time ultrasound guidance.
TPVB with 25 mlProcedure or surgery
The thoracic paravertebral block will be applied to the patients with 25 ml of 0.25% bupivacaine under real-time ultrasound guidance.
TPVB with 30 mlProcedure or surgery
The thoracic paravertebral block will be applied to the patients with 30 ml of 0.25% bupivacaine under real-time ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Paravertebral Block 20 ml | 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: TPVB with 20 ml |
| Thoracic Paravertebral Block 25 ml | 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. 25 ml of 0.25% bupivacaine will be injected into this area. Receives: Procedure: TPVB with 25 ml |
| Thoracic Paravertebral Block 30 ml | 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. 30 ml of 0.25% bupivacaine will be injected into this area. Receives: Procedure: TPVB with 30 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 1st hour after surgery
Pain Scores
Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 2nd-hour after surgery
Pain Scores
Pain will be assessed at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 4th-hour after surgery
Pain Scores
Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 12th-hour after surgery.
Pain Scores
Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 24th-hour after surgery.
Pain Scores
Pain will be assessed at the 48th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Measured: 48th-hour after surgery.
Secondary outcomes (1)
Morphine Consumption
Morphine consumption for 24 hours will be recorded
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start28 Dec 2022
- Primary completion28 Nov 2024 (estimated)
- Study completion28 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Paravertebral BlockStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgün Zengin, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700357
- Sponsor's protocol ID
- E.Kurul-E1-22-3143
- Status last verified
- Feb 2024
- First submitted
- 7 Jan 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Local Anesthetic Volumes of Thoracic Paravertebral Block Application in Post-thoracotomy Analgesia
- ClinicalTrials.gov ID
- NCT05700357
- Acronym / sponsor ID
- E.Kurul-E1-22-3143
- Conditions
- Thoracic Paravertebral Block, Thoracotomy, Postoperative Analgesia, Acute Pain, Local Anesthetic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 28 Nov 2024 (estimated)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 26 Jan 2023 (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.
Thoracotomy is one of the most painful operations known. Therefore, it causes severe acute pain. If pain is not controlled, it increases the frequency of postoperative pulmonary complications and postoperative morbidity. It can even cause chronic pain in the future. Thoracic epidural analgesia (TEA) is the gold standard method in the treatment of pain after thoracotomy. Thoracic paravertebral block (TPVB) is known as the most effective method after TEA. The fact that TPVB has fewer side effects than TEA increases the use of TPVB. There is no consensus on the dose of analgesia in studies. In the literature, volumes between 20 ml and 30 ml are frequently used for TPVB in recent years. This study, it was aimed to compare the efficacy of 20 ml, 25 ml, and 30 ml volumes of TPVB with local anesthetic at the same concentration (0.25% bupivacaine) on postoperative analgesia in patients undergoing thoracotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thoracic Paravertebral Block 20 ml | Active comparator | Procedure: TPVB with 20 mlIn 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. |
| Thoracic Paravertebral Block 25 ml | Active comparator | Procedure: TPVB with 25 mlIn 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. 25 ml of 0.25% bupivacaine will be injected into this area. |
| Thoracic Paravertebral Block 30 ml | Active comparator | Procedure: TPVB with 30 mlIn 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. 30 ml of 0.25% bupivacaine will be injected into this area. |
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
- American Society of Anesthesiologists (ASA) physical status I-II-III
- BMI 18 to 40 kg/m2
- Elective thoracotomy surgery
Key exclusion criteria (3 listed)
- Patient refusing the procedure
- Emergency surgery
- History of chronic opioid or analgesic used
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 |
|---|---|---|
| TPVB with 20 mlThe thoracic paravertebral block will be applied to the patients with 20 ml of 0.25% bupivacaine under real-time ultrasound guidance. | Procedure or surgery | Thoracic Paravertebral Block 20 ml |
| TPVB with 25 mlThe thoracic paravertebral block will be applied to the patients with 25 ml of 0.25% bupivacaine under real-time ultrasound guidance. | Procedure or surgery | Thoracic Paravertebral Block 25 ml |
| TPVB with 30 mlThe thoracic paravertebral block will be applied to the patients with 30 ml of 0.25% bupivacaine under real-time ultrasound guidance. | Procedure or surgery | Thoracic Paravertebral Block 30 ml |
Primary outcome
Pain Scores
Time frame: 1st hour after surgery
Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain Scores
Time frame: 2nd-hour after surgery
Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain Scores
Time frame: 4th-hour after surgery
Pain will be assessed at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain Scores
Time frame: 12th-hour after surgery.
Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain Scores
Time frame: 24th-hour after surgery.
Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain Scores
Time frame: 48th-hour after surgery.
Pain will be assessed at the 48th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
1 secondary outcome
Morphine Consumption
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TPVB with 20 ml, TPVB with 25 ml and TPVB with 30 ml in people with Thoracic Paravertebral Block and Thoracotomy, run by Ankara City Hospital Bilkent 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: status not confirmed, as of the sponsor's last update on 28 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?
Contact Emine N ZENGİN (+905063370548, nilbavullu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: 1st hour after surgery). The study lists 6 primary outcomes in all. 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 28 Feb 2024.