AnalgesiaNCT05852561
Comparison of Superficial+Deep Vs. Deep Serratus Anterior Plan Block in Video-Assisted Thoracic Surgery
A study testing Group Superficial+Deep Serratus Anterior Plan Block and Group Deep Serratus Anterior Plan Block in people with Analgesia, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Thoracotomy is one of the most painful surgeries; Video-assisted thoracoscopic surgery (VATS) has been developed to reduce the surgical stress of thoracotomy. However, patients may experience moderate to severe pain within the first 24 hours after VATS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Group Superficial+Deep Serratus Anterior Plan Block and Group Deep Serratus Anterior Plan Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 15 Dec 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist's physiologic state I-III patients
- To undergo Video Assisted Thoracic Surgery
- Being between the ages of 18-65 years
Who cannot join
- having a known heart, kidney, liver or hematological disease
- having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain
- Routine analgesic use and history of analgesic use in the last 24 hours
- Not willingto participate in the study
- Uncooperative patients who have coagulopathy or use anticoagulant drugs
- To be allergic to one of the drugs to be used
- Contraindication for Video Assisted Thoracic Surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Combined Superficial and Deep Serratus Anterior Plan Block Versus Deep Serratus Anterior Plan Block for Postoperative Pain Control in Video-Assisted Thoracic Surgery
Thoracotomy is one of the most painful surgeries; Video-assisted thoracoscopic surgery (VATS) has been developed to reduce the surgical stress of thoracotomy. However, patients may experience moderate to severe pain within the first 24 hours after VATS. Intravenous opioids are frequently used to provide postoperative analgesia, and accordingly, side effects such as postoperative nausea/vomiting and respiratory depression can be seen.
The aim of this study is to compare Superficial+Deep Vs. Deep Serratus Anterior Plan Block for postoperative pain control in VATS cases.
- Conditions
- Analgesia
- Being tested
- Group Superficial+Deep Serratus Anterior Plan Block, Group Deep Serratus Anterior Plan Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Superficial+Deep Serratus Anterior Plan BlockOther
The block will be performed after induction of general anesthesia and surgical positioning. 15 ml of 0.375% Bupivacaine + epinephrine 5 µg/ml will be administered between the serratus anterior and latissimus dorsalis muscles. The same concentration of block fluid will be applied between the serratus anterior and the outer intercostal muscle.
Group Deep Serratus Anterior Plan BlockOther
30 ml 0.375% Bupivacaine + epinephrine 5 µg/ml will be administered between the serratus anterior and outer intercostal muscle.
| Study group | Role | What they receive |
|---|---|---|
| Group Superficial+Deep Serratus Anterior Plan Block | Active comparator | Superficial+Deep Serratus Anterior Plan Block after Video-Assisted Thoracic Surgery Receives: Other: Group Superficial+Deep Serratus Anterior Plan Block |
| Group Deep Serratus Anterior Plan Block | Active comparator | Deep Serratus Anterior Plan Block after Video-Assisted Thoracic Surgery Receives: Other: Group Deep Serratus Anterior Plan Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
First 24 hours total fentanyl consumption with patient controlled analgesia
Measured: first 24 hours
Secondary outcomes (1)
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score
Measured: first 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start15 May 2023
- Primary completion15 Nov 2023
- Study completion15 Dec 2023
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 AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Oral Ahiskalioglu, Ataturk University
- Investigators
- Elif Oral Ahiskalioglu, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852561
- Sponsor's protocol ID
- ataunivatsanalgesia
- Status last verified
- Apr 2024
- First submitted
- 2 May 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee J, Kim S. The effects of ultrasound-guided serratus plane block, in combination with general anesthesia, on intraoperative opioid consumption, emergence time, and hemodynamic stability during video-assisted thoracoscopic lobectomy: A randomized prospective study. Medicine (Baltimore). 2019 May;98(18):e15385. doi: 10.1097/MD.0000000000015385.
PubMed 31045789Qiu L, Bu X, Shen J, Li M, Yang L, Xu Q, Chen Y, Yang J. Observation of the analgesic effect of superficial or deep anterior serratus plane block on patients undergoing thoracoscopic lobectomy. Medicine (Baltimore). 2021 Jan 22;100(3):e24352. doi: 10.1097/MD.0000000000024352.
PubMed 33546068
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Combined Superficial and Deep Serratus Anterior Plan Block Versus Deep Serratus Anterior Plan Block for Postoperative Pain Control in Video-Assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT05852561
- Acronym / sponsor ID
- ataunivatsanalgesia
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 10 May 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 surgeries; Video-assisted thoracoscopic surgery (VATS) has been developed to reduce the surgical stress of thoracotomy. However, patients may experience moderate to severe pain within the first 24 hours after VATS. Intravenous opioids are frequently used to provide postoperative analgesia, and accordingly, side effects such as postoperative nausea/vomiting and respiratory depression can be seen.
The aim of this study is to compare Superficial+Deep Vs. Deep Serratus Anterior Plan Block for postoperative pain control in VATS cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Superficial+Deep Serratus Anterior Plan Block | Active comparator | Other: Group Superficial+Deep Serratus Anterior Plan BlockSuperficial+Deep Serratus Anterior Plan Block after Video-Assisted Thoracic Surgery |
| Group Deep Serratus Anterior Plan Block | Active comparator | Other: Group Deep Serratus Anterior Plan BlockDeep Serratus Anterior Plan Block after Video-Assisted Thoracic Surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist's physiologic state I-III patients
- To undergo Video Assisted Thoracic Surgery
- Being between the ages of 18-65 years
Key exclusion criteria (7 listed)
- having a known heart, kidney, liver or hematological disease
- having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain
- Routine analgesic use and history of analgesic use in the last 24 hours
- Not willingto participate in the study
- Uncooperative patients who have coagulopathy or use anticoagulant drugs
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 |
|---|---|---|
| Group Superficial+Deep Serratus Anterior Plan BlockThe block will be performed after induction of general anesthesia and surgical positioning. 15 ml of 0.375% Bupivacaine + epinephrine 5 µg/ml will be administered between the serratus anterior and latissimus dorsalis muscles. The same concentration of block fluid will be applied between the serratus anterior and the outer intercostal muscle. | Other | Group Superficial+Deep Serratus Anterior Plan Block |
| Group Deep Serratus Anterior Plan Block30 ml 0.375% Bupivacaine + epinephrine 5 µg/ml will be administered between the serratus anterior and outer intercostal muscle. | Other | Group Deep Serratus Anterior Plan Block |
Primary outcome
Postoperative opioid consumption
Time frame: first 24 hours
First 24 hours total fentanyl consumption with patient controlled analgesia
1 secondary outcome
Visual analog pain score
Time frame: first 48 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 16 Apr 2024.
- Background: PubMed 31045789Lee J, Kim S. The effects of ultrasound-guided serratus plane block, in combination with general anesthesia, on intraoperative opioid consumption, emergence time, and hemodynamic stability during video-assisted thoracoscopic lobectomy: A randomized prospective study. Medicine (Baltimore). 2019 May;98(18):e15385. doi: 10.1097/MD.0000000000015385.
- Background: PubMed 33546068Qiu L, Bu X, Shen J, Li M, Yang L, Xu Q, Chen Y, Yang J. Observation of the analgesic effect of superficial or deep anterior serratus plane block on patients undergoing thoracoscopic lobectomy. Medicine (Baltimore). 2021 Jan 22;100(3):e24352. doi: 10.1097/MD.0000000000024352.
- Individual participant dataSharing planned: Undecided
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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.
Elif Oral Ahiskalioglu study director
Ataturk 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 Group Superficial+Deep Serratus Anterior Plan Block and Group Deep Serratus Anterior Plan Block in people with Analgesia, run by Ataturk 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 3 inclusion and 7 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 16 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?
Postoperative opioid consumption (time frame: first 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 NCT05852561, 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 16 Apr 2024.