Video-Assisted Thoracoscopic SurgeryNCT06352398
Comparison of Analgesic Efficacy in Video-Assisted Thoracoscopic Surgery Patients
A study testing erector spina plan block, Serratus posterior superior intercostal plan block (SPSIPB) and 0.25% bupivacaine in people with Video-Assisted Thoracoscopic Surgery, run by Burcu Bozdogan Tuysuz at 1 site in Turkey (Türkiye).
Trial summary
The 52 patients included in the study were divided into two groups as ESPB (n=26) and SPSIPB (n=26). Before the operation, 0.25% bupivacaine 30 ml was administered to both groups. After admission to the operating room, all patients underwent standard anaesthesia procedures. Morphine 0.05 mg/kg i.v. and parol 1 g i.v. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Video-Assisted Thoracoscopic Surgery
- What is being tested?
- erector spina plan block, Serratus posterior superior intercostal plan block (SPSIPB) and 0.25% bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2023to 1 Apr 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 52 healthy volunteers with VATS
- ASA 1-2-3
- 18 to 80 years old
Who cannot join
- patients with coagulopathy
- wound and infection in the block area
- allergy to local anaesthetic drugs
- mental retardation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medenıyet Unıversıty
Istanbul, Kadıkoy, 34734
About this study
The 52 patients included in the study were divided into two groups as ESPB (n=26) and SPSIPB (n=26). Before the operation, 0.25% bupivacaine 30 ml was administered to both groups. After admission to the operating room, all patients underwent standard anaesthesia procedures. Morphine 0.05 mg/kg i.v. and parol 1 g i.v. were administered 30 min before the end of the operation. Post operatively the patient was followed up with controlled analgesia. Demographic data, ASA scores, body mass indexes, peri-operative haemodynamic values, remifentanil consumption and duration of surgery were recorded. Post-operative first 24 hours NRS scores, morphine consumption, number of nausea and vomiting episodes were recorded.
Read the detailed description
The aim of the study is to evaluate the effect of erector spina plan block (ESPB) and Serratus posterior superior intercostal plan block (SPSIPB) on postoperative analgesia management.
After providing asepsis and antisepsis conditions to the ESPB group in the sitting position, a high frequency linear USG probe will be placed approximately 2-3 cm lateral to the T5 spinous process in the longitudinal plane. After visualising the T5 transverse process with the in plane approach, the skin will be entered in the craniocaudal direction. Trapezius, rhomboid and erector spinae muscles will be passed and 5 ml of saline will be injected between the erector spinae muscle fascia and vertebral transverse process when the needle rests on the spinous process (approximately 3 cm deep) and the block site will be confirmed. Then 30 ml of 0.25% bupivacaine (1mg/kg) will be injected by negative aspiration.
In the SPSIPB group, the patient will be positioned in the lateral position, with the surgical side up and the upper extremity hanging over the patient's head for the USG-guided serratus posterior superior plan block. After asepsis and antisepsis conditions are provided, the spina scapula will be visualised above the scapula with our high frequency linear USG probe. The 3rd rib will be visualised with a high frequency probe medial to the scapula corresponding to the 3rd rib level. The ribs, pleura and the serratus muscle covering it will be determined and the needle tip will be advanced until it touches the 3rd rib.After the 3rd rib is visualised by USG, 5 ml isotonic is given and hydrodissection is performed, 30 ml 0.25% bupivacaine (1mg/kg) will be injected between the serratus posterior superior muscle and the 3rd rib. The craniocaudal spread of local anaesthetic will be visualised by USG. Afterwards, the patients will be taken to the operation room and routine monitoring including ECG, peripheral oxygen saturation, non-invasive blood pressure arterial pressure monitoring and bispectral index (BIS) monitoring will be performed.
- Conditions
- Video-Assisted Thoracoscopic Surgery
- Being tested
- erector spina plan block, Serratus posterior superior intercostal plan block (SPSIPB), 0.25% bupivacaine
- Keywords
- Erector spina plan block, postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spina plan blockProcedure or surgery
erector spina plan block
Serratus posterior superior intercostal plan block (SPSIPB)Procedure or surgery
Serratus posterior superior intercostal plan block (SPSIPB)
0.25% bupivacaineDrug
Before the operation, 0.25% bupivacaine 30 ml was administered to both groups.
| Study group | Role | What they receive |
|---|---|---|
| erector spina plan block (ESPB) | Active comparator | erector spina plan block (ESPB) : After providing asepsis and antisepsis conditions to the ESPB group in the sitting position, a high frequency linear USG probe will be placed approximately 2-3 cm lateral to the T5 spinous process in the longitudinal plane. After visualising the T5 transverse process with the in plane approach, the skin will be entered in the craniocaudal direction. Trapezius, rhomboid and erector spinae muscles will be passed and 5 ml of saline will be injected between the erector spinae muscle fascia and vertebral transverse process when the needle rests on the spinous process (approximately 3 cm deep) and the block site will be confirmed. Before the operation 30 ml of 0.25% bupivacaine (1mg/kg) will be injected by negative aspiration. Receives: Procedure: erector spina plan block; Drug: 0.25% bupivacaine |
| Serratus posterior superior intercostal plan block (SPSIPB) | Active comparator | In the SPSIPB group, the patient will be positioned in the lateral position, with the surgical side up and the upper extremity hanging over the patient's head for the USG-guided serratus posterior superior plan block. After asepsis and antisepsis conditions are provided, the spina scapula will be visualised above the scapula with our high frequency linear USG probe. The 3rd rib will be visualised with a high frequency probe medial to the scapula corresponding to the 3rd rib level. The ribs, pleura and the serratus muscle covering it will be determined and the needle tip will be advanced until it touches the 3rd rib.After the 3rd rib is visualised by USG, 5 ml isotonic is given and hydrodissection is performed, 30 ml 0.25% bupivacaine (1mg/kg) will be injected between the serratus posterior superior muscle and the 3rd rib. Receives: Procedure: Serratus posterior superior intercostal plan block (SPSIPB); Drug: 0.25% bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption first 24 hours
mg
Measured: up to 24 hours
Secondary outcomes (1)
NRS pain score
0 painless to 10 very painful
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start20 Dec 2023
- Primary completion1 Feb 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burcu Bozdogan Tuysuz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Burcu Bozdogan Tuysuz, Istanbul Medeniyet University
- Investigators
- burcu bozdogan tuysuz, Study director, medenıyet unıversıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352398
- Sponsor's protocol ID
- BBTuysuz
- Status last verified
- Apr 2024
- First submitted
- 21 Dec 2023
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 36883093
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy in Video-Assisted Thoracoscopic Surgery Patients
- ClinicalTrials.gov ID
- NCT06352398
- Acronym / sponsor ID
- BBTuysuz
- Conditions
- Video-Assisted Thoracoscopic Surgery
- Keywords
- Erector spina plan block, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Burcu Bozdogan TuysuzUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 8 Apr 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 52 patients included in the study were divided into two groups as ESPB (n=26) and SPSIPB (n=26). Before the operation, 0.25% bupivacaine 30 ml was administered to both groups. After admission to the operating room, all patients underwent standard anaesthesia procedures. Morphine 0.05 mg/kg i.v. and parol 1 g i.v. were administered 30 min before the end of the operation. Post operatively the patient was followed up with controlled analgesia. Demographic data, ASA scores, body mass indexes, peri-operative haemodynamic values, remifentanil consumption and duration of surgery were recorded. Post-operative first 24 hours NRS scores, morphine consumption, number of nausea and vomiting episodes were recorded.
Detailed description
The aim of the study is to evaluate the effect of erector spina plan block (ESPB) and Serratus posterior superior intercostal plan block (SPSIPB) on postoperative analgesia management.
After providing asepsis and antisepsis conditions to the ESPB group in the sitting position, a high frequency linear USG probe will be placed approximately 2-3 cm lateral to the T5 spinous process in the longitudinal plane. After visualising the T5 transverse process with the in plane approach, the skin will be entered in the craniocaudal direction. Trapezius, rhomboid and erector spinae muscles will be passed and 5 ml of saline will be injected between the erector spinae muscle fascia and vertebral transverse process when the needle rests on the spinous process (approximately 3 cm deep) and the block site will be confirmed. Then 30 ml of 0.25% bupivacaine (1mg/kg) will be injected by negative aspiration.
In the SPSIPB group, the patient will be positioned in the lateral position, with the surgical side up and the upper extremity hanging over the patient's head for the USG-guided serratus posterior superior plan block. After asepsis and antisepsis conditions are provided, the spina scapula will be visualised above the scapula with our high frequency linear USG probe. The 3rd rib will be visualised with a high frequency probe medial to the scapula corresponding to the 3rd rib level. The ribs, pleura and the serratus muscle covering it will be determined and the needle tip will be advanced until it touches the 3rd rib.After the 3rd rib is visualised by USG, 5 ml isotonic is given and hydrodissection is performed, 30 ml 0.25% bupivacaine (1mg/kg) will be injected between the serratus posterior superior muscle and the 3rd rib. The craniocaudal spread of local anaesthetic will be visualised by USG. Afterwards, the patients will be taken to the operation room and routine monitoring including ECG, peripheral oxygen saturation, non-invasive blood pressure arterial pressure monitoring and bispectral index (BIS) monitoring will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erector spina plan block (ESPB) | Active comparator | Procedure: erector spina plan block, Drug: 0.25% bupivacaineerector spina plan block (ESPB) : After providing asepsis and antisepsis conditions to the ESPB group in the sitting position, a high frequency linear USG probe will be placed approximately 2-3 cm lateral to the T5 spinous process in the longitudinal plane. After visualising the T5 transverse process with the in plane approach, the skin will be entered in the craniocaudal direction. Trapezius, rhomboid and erector spinae muscles will be passed and 5 ml of saline will be injected between the erector spinae muscle fascia and vertebral transverse process when the needle rests on the spinous process (approximately 3 cm deep) and the block site will be confirmed. Before the operation 30 ml of 0.25% bupivacaine (1mg/kg) will be injected by negative aspiration. |
| Serratus posterior superior intercostal plan block (SPSIPB) | Active comparator | Procedure: Serratus posterior superior intercostal plan block (SPSIPB), Drug: 0.25% bupivacaineIn the SPSIPB group, the patient will be positioned in the lateral position, with the surgical side up and the upper extremity hanging over the patient's head for the USG-guided serratus posterior superior plan block. After asepsis and antisepsis conditions are provided, the spina scapula will be visualised above the scapula with our high frequency linear USG probe. The 3rd rib will be visualised with a high frequency probe medial to the scapula corresponding to the 3rd rib level. The ribs, pleura and the serratus muscle covering it will be determined and the needle tip will be advanced until it touches the 3rd rib.After the 3rd rib is visualised by USG, 5 ml isotonic is given and hydrodissection is performed, 30 ml 0.25% bupivacaine (1mg/kg) will be injected between the serratus posterior superior muscle and the 3rd rib. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 52 healthy volunteers with VATS
- ASA 1-2-3
- 18 to 80 years old
Key exclusion criteria (4 listed)
- patients with coagulopathy
- wound and infection in the block area
- allergy to local anaesthetic drugs
- mental retardation
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 spina plan blockerector spina plan block | Procedure or surgery | erector spina plan block (ESPB) |
| Serratus posterior superior intercostal plan block (SPSIPB)Serratus posterior superior intercostal plan block (SPSIPB) | Procedure or surgery | Serratus posterior superior intercostal plan block (SPSIPB) |
| 0.25% bupivacaineBefore the operation, 0.25% bupivacaine 30 ml was administered to both groups. | Drug | Serratus posterior superior intercostal plan block (SPSIPB), erector spina plan block (ESPB) |
Primary outcome
morphine consumption first 24 hours
Time frame: up to 24 hours
mg
1 secondary outcome
NRS pain score
Time frame: up to 24 hours
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 8 Apr 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.
- httpLink provided by the sponsor.
- 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.
burcu bozdogan tuysuz study director
medenıyet unıversıty
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 spina plan block, Serratus posterior superior intercostal plan block (SPSIPB) and 0.25% bupivacaine in people with Video-Assisted Thoracoscopic Surgery, run by Burcu Bozdogan Tuysuz 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 3 inclusion and 4 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 8 Apr 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?
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?
morphine consumption first 24 hours (time frame: up to 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 NCT06352398, which also lists 1 linked publication.
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 8 Apr 2024.