Lung DiseasesNCT05972122
Serratus Posterior Superior Interfascial Plane Block for Thoracoscopic Surgery
A study testing Analgesia management; group S and C in people with Lung Diseases, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Regional techniques can be used for postoperative pain control following VATS. Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Analgesia management; group S and C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Aug 2023to 30 Jun 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
- American Society of Anesthesiologists (ASA) classification I-III
- Scheduled for VATS under general anesthesia
Who cannot join
- history of bleeding diathesis,
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- pregnancy or lactation,
- patients who do not accept the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
About this study
Official title: The Efficacy of Serratus Posterior Superior Interfacial Plane Block on Postoperative Analgesia in Patients Underwent Video-Assisted Thoracoscopic Surgery: A Randomized, Prospective, Controlled Study
Regional techniques can be used for postoperative pain control following VATS. Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided.
Read the detailed description
Video-assisted thoracic surgery (VATS) has started to be considered the standard surgical procedure for lung surgery in recent years. The advantages of VATS compared to open thoracotomy are rapid recovery, shorter hospital stays, and low risk of complications. Although it is a less painful surgical procedure compared to thoracotomy, severe acute postoperative pain can be observed especially in the first hours after VATS. Thoracic epidural analgesia (TEA), which is the gold standard for post-thoracotomy analgesia, is used in analgesia after VATS. However, due to the difference in surgical technique and trauma between open surgery and VATS, what should be the gold standard for analgesia after VATS is a matter of debate. It is supported that less invasive analgesic techniques should be applied for minimally invasive surgical procedures, especially due to the difficulty of applying TEA and its side-effect profile. Thoracic paravertebral block (TPVB) is considered the first-line regional technique for VATS surgery. However, it is difficult to apply due to its anatomical proximity to important structures such as the pleura and central neuraxial system, and it may cause complications such as pneumothorax and vascular injury. Analgesia management is very important in these patients, as insufficient analgesia in the postoperative period may cause pulmonary complications such as atelectasis, pneumonia, and increased oxygen consumption.
Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided.
In the cadaveric study of Tulgar et al., it was determined that the spread of serratus posterior superior interfacial plane block; 7-10 intercostal levels on the left side only in the superficial fascia of the trapezius muscle. Spread dye was observed at intercostal levels, absent on the right. There was prominent staining on both sides of the deep trapezius muscle. Both the surface and skin of the rhomboid major were stained, while the rhomboid minor was only stained in the skin. SPSP block will provide successful analgesia in procedures involving the thoracic region such as chronic myofascial pain, breast surgery, thoracic surgery, and shoulder surgery. There is no randomized study in the literature evaluating the effectiveness of SPSP block for postoperative analgesia management after VATS.
In this study, we aim to evaluate the effectiveness of US-guided SPSP block for postoperative analgesia management after VATS. Our primary aim is to compare postoperative opioid consumption, our secondary aim is to evaluate postoperative pain scores (NRS), opioid-related side effects (allergic reaction, nausea, vomiting), and dermatome levels.
- Conditions
- Lung Diseases
- Being tested
- Analgesia management; group S and C
- Keywords
- VATS, Postoperative pain management, Serratus Posterior Superior Interfascial Plane Block
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia management; group S and CDrug
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including 10 mcg bolus without infusion dose, 10 min lockout time, and 4-hour limit. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group S = SPSIPB group | Placebo comparator | A high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The procedure will be performed with the patient in the lateral decubitus position. After the scapula is shifted slightly laterally, the US probe is placed sagittal at the upper corner of the spina scapula, and the serratus posterior superior muscle is visualized with the third rib. The in-plane technique will be used. The block needle will be advanced in the craniocaudal direction to enter between the serratus posterior superior and the third rib. The block location will be confirmed by injecting 5 ml of saline between the rib and the muscle. After the block location is confirmed, 30 ml of 0.25% concentration bupivacaine will be used. Receives: Drug: Analgesia management; group S and C |
| Group C = Control group | Other | The intercostal infiltration with 30 ml of 0.25% concentration of bupivacaine will be performed by the surgical team. Receives: Drug: Analgesia management; group S and C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption (Fentanyl PCA)
The primary aim is to compare postoperative opioid consumption from the PCA device.
Measured: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Secondary outcomes (3)
Pain scores (Numerical rating scale-NRS)
The secondary aim is to compare NRS at the postoperative 24 h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded
Measured: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
Need for rescue analgesia (meperidine)
The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
Measured: Postoperative 24 hours period
Adverse events
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use.
Measured: Postoperative 24 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start9 Aug 2023
- Primary completion20 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe 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
- Model description
- There are two models for this study. The first group is the SPSIPB group. The second one is the control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972122
- Sponsor's protocol ID
- Medipol Hospital 34
- Status last verified
- Aug 2024
- First submitted
- 25 Jul 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not plan to share IPD
Publications
Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
PubMed 36883093Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block for breast surgery: a report of three cases, novel block and new indication. Minerva Anestesiol. 2023 Nov;89(11):1054-1056. doi: 10.23736/S0375-9393.23.17432-3. Epub 2023 Jun 1. No abstract available.
PubMed 37272274
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Serratus Posterior Superior Interfacial Plane Block on Postoperative Analgesia in Patients Underwent Video-Assisted Thoracoscopic Surgery: A Randomized, Prospective, Controlled Study
- ClinicalTrials.gov ID
- NCT05972122
- Acronym / sponsor ID
- Medipol Hospital 34
- Conditions
- Lung Diseases
- Keywords
- VATS, Postoperative pain management, Serratus Posterior Superior Interfascial Plane Block
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 2 Aug 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.
Regional techniques can be used for postoperative pain control following VATS. Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided.
Detailed description
Video-assisted thoracic surgery (VATS) has started to be considered the standard surgical procedure for lung surgery in recent years. The advantages of VATS compared to open thoracotomy are rapid recovery, shorter hospital stays, and low risk of complications. Although it is a less painful surgical procedure compared to thoracotomy, severe acute postoperative pain can be observed especially in the first hours after VATS. Thoracic epidural analgesia (TEA), which is the gold standard for post-thoracotomy analgesia, is used in analgesia after VATS. However, due to the difference in surgical technique and trauma between open surgery and VATS, what should be the gold standard for analgesia after VATS is a matter of debate. It is supported that less invasive analgesic techniques should be applied for minimally invasive surgical procedures, especially due to the difficulty of applying TEA and its side-effect profile. Thoracic paravertebral block (TPVB) is considered the first-line regional technique for VATS surgery. However, it is difficult to apply due to its anatomical proximity to important structures such as the pleura and central neuraxial system, and it may cause complications such as pneumothorax and vascular injury. Analgesia management is very important in these patients, as insufficient analgesia in the postoperative period may cause pulmonary complications such as atelectasis, pneumonia, and increased oxygen consumption.
Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided.
In the cadaveric study of Tulgar et al., it was determined that the spread of serratus posterior superior interfacial plane block; 7-10 intercostal levels on the left side only in the superficial fascia of the trapezius muscle. Spread dye was observed at intercostal levels, absent on the right. There was prominent staining on both sides of the deep trapezius muscle. Both the surface and skin of the rhomboid major were stained, while the rhomboid minor was only stained in the skin. SPSP block will provide successful analgesia in procedures involving the thoracic region such as chronic myofascial pain, breast surgery, thoracic surgery, and shoulder surgery. There is no randomized study in the literature evaluating the effectiveness of SPSP block for postoperative analgesia management after VATS.
In this study, we aim to evaluate the effectiveness of US-guided SPSP block for postoperative analgesia management after VATS. Our primary aim is to compare postoperative opioid consumption, our secondary aim is to evaluate postoperative pain scores (NRS), opioid-related side effects (allergic reaction, nausea, vomiting), and dermatome levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two models for this study. The first group is the SPSIPB group. The second one is the control group.
| Arm | Type | Receives |
|---|---|---|
| Group S = SPSIPB group | Placebo comparator | Drug: Analgesia management; group S and CA high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The procedure will be performed with the patient in the lateral decubitus position. After the scapula is shifted slightly laterally, the US probe is placed sagittal at the upper corner of the spina scapula, and the serratus posterior superior muscle is visualized with the third rib. The in-plane technique will be used. The block needle will be advanced in the craniocaudal direction to enter between the serratus posterior superior and the third rib. The block location will be confirmed by injecting 5 ml of saline between the rib and the muscle. After the block location is confirmed, 30 ml of 0.25% concentration bupivacaine will be used. |
| Group C = Control group | Other | Drug: Analgesia management; group S and CThe intercostal infiltration with 30 ml of 0.25% concentration of bupivacaine will be performed by the surgical team. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification I-III
- Scheduled for VATS under general anesthesia
Key exclusion criteria (6 listed)
- history of bleeding diathesis,
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- pregnancy or lactation,
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 |
|---|---|---|
| Analgesia management; group S and CPatients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including 10 mcg bolus without infusion dose, 10 min lockout time, and 4-hour limit. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure. | Drug | Group C = Control group, Group S = SPSIPB group |
Primary outcome
Opioid consumption (Fentanyl PCA)
Time frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
The primary aim is to compare postoperative opioid consumption from the PCA device.
3 secondary outcomes
Pain scores (Numerical rating scale-NRS)
Time frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
Need for rescue analgesia (meperidine)
Time frame: Postoperative 24 hours period
Adverse events
Time frame: Postoperative 24 hours period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 36883093Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
- Background: PubMed 37272274Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block for breast surgery: a report of three cases, novel block and new indication. Minerva Anestesiol. 2023 Nov;89(11):1054-1056. doi: 10.23736/S0375-9393.23.17432-3. Epub 2023 Jun 1. No abstract available.
- Individual participant dataSharing planned: No. We will not plan to share IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analgesia management; group S and C in people with Lung Diseases, run by Medipol 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 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: withdrawn, as of the sponsor's last update on 9 Aug 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Opioid consumption (Fentanyl PCA) (time frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05972122, which also lists 2 linked publications.
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 9 Aug 2024.