Postoperative PainNCT06177652
Postoperative Analgesis for Pain Management After Thoracotomy
A study testing Paravertebral Block and Serratus Plane Block in people with Postoperative Pain and Analgesia, run by Kocaeli University at 2 sites in Turkey (Türkiye).
Trial summary
Thoracotomy is among the most painful surgical procedures and can cause severe pain. Postoperative pain causes many complications. Therefore, pain management is important in patients undergoing thoracotomy. For this purpose, systemic analgesics are used along with ultrasound-guided nerve blocks in thoracotomy pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Analgesia
- What is being tested?
- Paravertebral Block and Serratus Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 4 Jul 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 aged patients
- American Society of Anesthesiologists Classification (ASA) I-II-III patients
- patients who scheduled elective thoracic surgery
Who cannot join
- American Society of Anesthesiologists Classification (ASA) IV-V patients
- patients with coagulopathy
- patient with infection at the injection site
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kocaeli University
Kocaeli
Nur Nazire Yucal
Kocaeli
About this study
Official title: Comparison of Thoracal Paravertebral Block and Serratus Plan Block in Pain Management After Thoracotomy
Thoracotomy is among the most painful surgical procedures and can cause severe pain. Postoperative pain causes many complications. Therefore, pain management is important in patients undergoing thoracotomy. For this purpose, systemic analgesics are used along with ultrasound-guided nerve blocks in thoracotomy pain. The effectiveness of thoracic paravertebral block and serratus plane block in the treatment of post-thoracotomy pain will be evaluated by comparing their effectiveness and complications on postoperative pain. Since the epidural spread of the thoracic paravertebral block is more effective, the effectiveness of postoperative pain relief will be more effective
Read the detailed description
Thoracotomy is among the most painful surgical procedures and can cause severe pain. This pain causes postoperative complications in patients who have thoracotomy surgery. Uncontrolled pain can cause respiratory and thromboembolic events. Therefore, effective pain management is important in patients undergoing thoracotomy. Investigators aim to compare the analgesic effectiveness and complications of thoracic paravertebral block and serratus anterior plane block in relieving thoracotomy pain, which is one of the most painful surgical procedures. It is aimed to compare the effectiveness and complications of thoracic paravertebral block and serratus plane block in postoperative pain control after thoracotomy. Providing pain control reduces postoperative complications and reduces hospital stay, which increases patient comfort and reduces costs. In this research, postoperative morphine consumption after block applications will be compared, and patients' analgesic needs will be evaluated according to the participants' VAS score. Post-operative 3rd, 6th, 9th, 12th, 24th. Morphine consumption will be evaluated by monitoring the hours. It will be evaluated whether there is a need for additional analgesics. During the operation, the patient's heart rate, blood pressure, saturation and temperature variable values will be closely monitored. Standard monitoring methods will be used when examining these parameters.
- Conditions
- Postoperative Pain, Analgesia
- Being tested
- Paravertebral Block, Serratus Plane Block
- Keywords
- Regional Anesthesia, Paravertebral Block, Serratus Plane Block, Thoracotomy
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral BlockOther
Ultrasound (US) -guided paravertebral block (PVB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the PVB group.
Serratus Plane BlockOther
Ultrasound (US) -guided serratus plane block (SPB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the SPB group.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral Block | Active comparator | Ultrasound (US) -guided paravertebral block (PVB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the PVB group. Receives: Other: Paravertebral Block |
| Serratus Plane Block | Active comparator | Ultrasound (US) -guided serratus plane block (SPB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the SPB group. Receives: Other: Serratus Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphin consumption
Patient in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia
Measured: during postoperative 24 hour
Secondary outcomes (1)
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) requires the patient to rate their pain on a defined scale.For example , 0-10 where 0 is no pain and 10 is the worst pain imaginable
Measured: during postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Jun 2022
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Nazire Yucal, Kocaeli University
- Investigators
- Tülay Çardaközü, Study director, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177652
- Sponsor's protocol ID
- KAEK/10.bI.02
- Status last verified
- Mar 2025
- First submitted
- 11 Dec 2023
- Last updated
- 10 Mar 2025
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Thoracal Paravertebral Block and Serratus Plan Block in Pain Management After Thoracotomy
- ClinicalTrials.gov ID
- NCT06177652
- Acronym / sponsor ID
- KAEK/10.bI.02
- Conditions
- Postoperative Pain, Analgesia
- Keywords
- Regional Anesthesia, Paravertebral Block, Serratus Plane Block, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 20 Dec 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 among the most painful surgical procedures and can cause severe pain. Postoperative pain causes many complications. Therefore, pain management is important in patients undergoing thoracotomy. For this purpose, systemic analgesics are used along with ultrasound-guided nerve blocks in thoracotomy pain. The effectiveness of thoracic paravertebral block and serratus plane block in the treatment of post-thoracotomy pain will be evaluated by comparing their effectiveness and complications on postoperative pain. Since the epidural spread of the thoracic paravertebral block is more effective, the effectiveness of postoperative pain relief will be more effective
Detailed description
Thoracotomy is among the most painful surgical procedures and can cause severe pain. This pain causes postoperative complications in patients who have thoracotomy surgery. Uncontrolled pain can cause respiratory and thromboembolic events. Therefore, effective pain management is important in patients undergoing thoracotomy. Investigators aim to compare the analgesic effectiveness and complications of thoracic paravertebral block and serratus anterior plane block in relieving thoracotomy pain, which is one of the most painful surgical procedures. It is aimed to compare the effectiveness and complications of thoracic paravertebral block and serratus plane block in postoperative pain control after thoracotomy. Providing pain control reduces postoperative complications and reduces hospital stay, which increases patient comfort and reduces costs. In this research, postoperative morphine consumption after block applications will be compared, and patients' analgesic needs will be evaluated according to the participants' VAS score. Post-operative 3rd, 6th, 9th, 12th, 24th. Morphine consumption will be evaluated by monitoring the hours. It will be evaluated whether there is a need for additional analgesics. During the operation, the patient's heart rate, blood pressure, saturation and temperature variable values will be closely monitored. Standard monitoring methods will be used when examining these parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral Block | Active comparator | Other: Paravertebral BlockUltrasound (US) -guided paravertebral block (PVB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the PVB group. |
| Serratus Plane Block | Active comparator | Other: Serratus Plane BlockUltrasound (US) -guided serratus plane block (SPB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the SPB group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 aged patients
- American Society of Anesthesiologists Classification (ASA) I-II-III patients
- patients who scheduled elective thoracic surgery
Key exclusion criteria (3 listed)
- American Society of Anesthesiologists Classification (ASA) IV-V patients
- patients with coagulopathy
- patient with infection at the injection site
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 |
|---|---|---|
| Paravertebral BlockUltrasound (US) -guided paravertebral block (PVB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the PVB group. | Other | Paravertebral Block |
| Serratus Plane BlockUltrasound (US) -guided serratus plane block (SPB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the SPB group. | Other | Serratus Plane Block |
Primary outcome
Morphin consumption
Time frame: during postoperative 24 hour
Patient in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia
1 secondary outcome
Visual Analogue Scale (VAS)
Time frame: during postoperative 24 hour
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 10 Mar 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. This study is not recruiting at the moment.
Tülay Çardaközü study director
Kocaeli University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral Block and Serratus Plane Block in people with Postoperative Pain and Analgesia, run by Kocaeli University 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 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 10 Mar 2025. 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?
Morphin consumption (time frame: during postoperative 24 hour). 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 10 Mar 2025.