Video-assisted Thoracoscopic SurgeryNCT06426706
TPVB or SPSIPB in Pain Management After VATS
A study testing Serratus Posterior Superior Intercostal Plane Block and Paravertebral Block in people with Video-assisted Thoracoscopic Surgery and Paravertebral Block, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the analgesic efficacy of thoracal paravertebral block (TPVB) and serratus posterior superior intercostal plane block (SPSIPB) in patients undergoing video-assisted thoracoscopic surgery (VATS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Video-assisted Thoracoscopic Surgery, Paravertebral Block, Serratus Posterior Superior Intercostal Plane Block
- What is being tested?
- Serratus Posterior Superior Intercostal Plane Block and Paravertebral Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2025to 15 Mar 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the age of 18-80 undergoing video-assisted thoracoscopic surgery
Who cannot join
- Allergy to local anaesthetics Chronic opioid use history Patients with psychiatric disorders Patients who are not open to communication Patients with chronic organ failure Patients that do not give consent Patients that need emergency surgery within the first 24 hours of the initial surgery
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, 1 recruiting
- Recruiting
Koc University
Istanbul, 34010
Kamil Darçın, +905055895099, kdarcin@ku.edu.tr
Yasemin Sincer, +90512040834, sincer.yasemin@gmail.com
About this study
Official title: Paravertebral Block or Serratus Posterior Superior Intercostal Plane Block in Pain Management After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to compare the analgesic efficacy of thoracal paravertebral block (TPVB) and serratus posterior superior intercostal plane block (SPSIPB) in patients undergoing video-assisted thoracoscopic surgery (VATS). The main questions it aims to answer are:
How will the total perioperative opioid consumption of the patients receiving two different blocks change? How will TPVB and SPSIPB effect the patients' numeric rating scores for pain in the postoperative 24-hour period? How will TPVB and SPSIPB effect the incidence of opioid related side effects?
Read more
Participants will be divided in two groups:
TPVB group will receive a TPVB before the surgery. SPSIPB group will receive a SPSIPB nerve block before the surgery. Researchers will compare the results between the groups to see the postoperative effects concerning opioid consumption as well as the pain scores, respiratory parameters and opioid associated side effects.
The hypothesis of this study is that participants receiving SPSIPB for VATS will have a less total opioid consumption 24 hours postoperatively.
Read the detailed description
Video-assisted thoracoscopic surgeries require a surgical incision of the lateral thoracic wall. In order to ease the postoperative pain of patients undergoing VATS, some regional anaesthesia techniques have been tried but there is no consensus on the best method. The gold standard peripheric nerve block is considered to be thoracal paravertebral block (TPVB). Recently, a new nerve block called serratus posterior superior intercostal plane block (SPSIPB) has been described. The anatomic and radiologic studies of SPSIPB suggest that the local anaesthetic distributes from C7 to T10 vertebrates, covering the surgical site of VATS. This study aims to compare the analgesic efficacy of TPVB and SPSIPB for VATS. The hypothesis is that participants receiving SPSIPB for VATS will have a less total opioid consumption 24 hours postoperatively. Also, the postoperative pain scores and opioid related side effects of the participants will be recorded. Participants will be divided in two groups. The group P will receive a TPVB preoperatively in the operating room. The group S will receive a SPSIPB preoperatively in the operating room. The participants will be followed 24 hours postoperatively and their total opioid consumption, numeric rating scores for pain, incidence of opioid related side effects will be recorded. Also the participants and the surgical teams perioperative pain related satisfaction will be evaluated.
- Conditions
- Video-assisted Thoracoscopic Surgery, Paravertebral Block, Serratus Posterior Superior Intercostal Plane Block, Regional Anesthesia Morbidity
- Being tested
- Serratus Posterior Superior Intercostal Plane Block, Paravertebral Block
- Keywords
- video-assisted thoracoscopic surgery, paravertebral block, serratus posterior superior intercostal plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
Before the induction of general anesthesia, under aseptic conditions, serratus posterior superior intercostal plane block will be performed with a single dose of 30 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist.
Paravertebral BlockProcedure or surgery
Before the induction of general anesthesia, under aseptic conditions, paravertebral block will be performed with a single dose of 30 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Group S | Experimental | Participants who will be receiving a serratus posterior superior intercostal plane block with a single dose of 30 ml of %0,25 bupivacaine Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block |
| Group P | Active comparator | Participants who will be receiving a thoracal paravertebral block with a single dose of 30 ml of %0,25 bupivacaine Receives: Procedure: Paravertebral Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
all consumed opioids will be converted in morphine equivalents and then added to reach the total dosage
Measured: 24 hours post-surgery
Secondary outcomes (2)
Numeric rating scale scores for pain
the scale between 0: no pain and 10:highes pain answered by the participants
Measured: 24 hours post-surgery
Opioid related side effects
Nausea, vomiting, pruritis, respiratory depression assessed by yes/no questions
Measured: 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start3 Jan 2025 (estimated)
- Primary completion15 Feb 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-assisted Thoracoscopic SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamil Darcin, Koç University
- Investigators
- Kamil Darçın, MD, Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426706
- Sponsor's protocol ID
- 2024.174.IRB1.019
- Status last verified
- Jan 2025
- First submitted
- 19 May 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Block or Serratus Posterior Superior Intercostal Plane Block in Pain Management After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06426706
- Acronym / sponsor ID
- 2024.174.IRB1.019
- Conditions
- Video-assisted Thoracoscopic Surgery, Paravertebral Block, Serratus Posterior Superior Intercostal Plane Block, Regional Anesthesia Morbidity
- Keywords
- video-assisted thoracoscopic surgery, paravertebral block, serratus posterior superior intercostal plane block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 3 Jan 2025 (estimated)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 23 May 2024 (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 goal of this clinical trial is to compare the analgesic efficacy of thoracal paravertebral block (TPVB) and serratus posterior superior intercostal plane block (SPSIPB) in patients undergoing video-assisted thoracoscopic surgery (VATS). The main questions it aims to answer are:
How will the total perioperative opioid consumption of the patients receiving two different blocks change? How will TPVB and SPSIPB effect the patients' numeric rating scores for pain in the postoperative 24-hour period? How will TPVB and SPSIPB effect the incidence of opioid related side effects?
Participants will be divided in two groups:
TPVB group will receive a TPVB before the surgery. SPSIPB group will receive a SPSIPB nerve block before the surgery. Researchers will compare the results between the groups to see the postoperative effects concerning opioid consumption as well as the pain scores, respiratory parameters and opioid associated side effects.
The hypothesis of this study is that participants receiving SPSIPB for VATS will have a less total opioid consumption 24 hours postoperatively.
Detailed description
Video-assisted thoracoscopic surgeries require a surgical incision of the lateral thoracic wall. In order to ease the postoperative pain of patients undergoing VATS, some regional anaesthesia techniques have been tried but there is no consensus on the best method. The gold standard peripheric nerve block is considered to be thoracal paravertebral block (TPVB). Recently, a new nerve block called serratus posterior superior intercostal plane block (SPSIPB) has been described. The anatomic and radiologic studies of SPSIPB suggest that the local anaesthetic distributes from C7 to T10 vertebrates, covering the surgical site of VATS. This study aims to compare the analgesic efficacy of TPVB and SPSIPB for VATS. The hypothesis is that participants receiving SPSIPB for VATS will have a less total opioid consumption 24 hours postoperatively. Also, the postoperative pain scores and opioid related side effects of the participants will be recorded. Participants will be divided in two groups. The group P will receive a TPVB preoperatively in the operating room. The group S will receive a SPSIPB preoperatively in the operating room. The participants will be followed 24 hours postoperatively and their total opioid consumption, numeric rating scores for pain, incidence of opioid related side effects will be recorded. Also the participants and the surgical teams perioperative pain related satisfaction will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | Experimental | Procedure: Serratus Posterior Superior Intercostal Plane BlockParticipants who will be receiving a serratus posterior superior intercostal plane block with a single dose of 30 ml of %0,25 bupivacaine |
| Group P | Active comparator | Procedure: Paravertebral BlockParticipants who will be receiving a thoracal paravertebral block with a single dose of 30 ml of %0,25 bupivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between the age of 18-80 undergoing video-assisted thoracoscopic surgery
Key exclusion criteria (1 listed)
- Allergy to local anaesthetics Chronic opioid use history Patients with psychiatric disorders Patients who are not open to communication Patients with chronic organ failure Patients that do not give consent Patients that need emergency surgery within the first 24 hours of the initial surgery
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 |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane BlockBefore the induction of general anesthesia, under aseptic conditions, serratus posterior superior intercostal plane block will be performed with a single dose of 30 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist. | Procedure or surgery | Group S |
| Paravertebral BlockBefore the induction of general anesthesia, under aseptic conditions, paravertebral block will be performed with a single dose of 30 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist. | Procedure or surgery | Group P |
Primary outcome
Total opioid consumption
Time frame: 24 hours post-surgery
all consumed opioids will be converted in morphine equivalents and then added to reach the total dosage
2 secondary outcomes
Numeric rating scale scores for pain
Time frame: 24 hours post-surgery
Opioid related side effects
Time frame: 24 hours post-surgery
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 3 Jan 2025.
- Individual participant dataSharing planned: Yes
Related trials for Video-assisted Thoracoscopic Surgery
Not yet recruiting
TBLC vs NIVATS in Interstitial Lung Disease
Interstitial Lung Diseases (ILD)
Not yet recruiting
Post-operative Medium Chain Triglyceride Diet May Reduce Hospital Stay Following Lung Resection
Thoracic Neoplasms
Recruiting
Comparison of the Effectiveness of Midpoint Transverse Process to Pleura (MTP) Block and Erector Spinae Plane (ESP) Block in Video-Assisted Thoracoscopic Surgery (VATS) at RS Ngoerah
Pain, Postoperative Pain
Not yet recruitingObservational study
Comparison of Different Ventilation Modes in Video-Assisted Thoracoscopic Lung Resection
One-lung Ventilation (OLV), Video-assisted Thoracis Surgery (VATS)
Recruiting
Ultrasound-Guided Rhomboid-Intercostal Block Versus Thoracic Paravertebral Block for VATS Analgesia
Postoperative Pain, Thoracic Surgery
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.
Kamil Darçın, MD principal investigator
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus Posterior Superior Intercostal Plane Block and Paravertebral Block in people with Video-assisted Thoracoscopic Surgery and Paravertebral Block, 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Jan 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 Kamil Darçın, MD (+90 505 589 50 99, drdarcink@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption (time frame: 24 hours post-surgery). 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 3 Jan 2025.