AnalgesiaNCT06073197
Comparison of Erector Spinae Block and Combined Deep and Superficial Serratus Anterior Plane Block
A study testing erector spinae plane block and combined deep and superficial serratus anterior plane block in people with Analgesia and Pain, Postoperative, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The authors hypothesized that combined deep and superficial serratus anterior plane block (SAPB) is as effective as erector spinae plane block (ESPB) for intraoperative and postoperative analgesia for video-assisted thoracoscopic surgery. Design: A prospective randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Pain, Postoperative, Thoracic
- What is being tested?
- erector spinae plane block and combined deep and superficial serratus anterior plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jul 2020to 25 Feb 2021
- 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 Anaesthesiologists (ASA) classification I-II scheduled for elective VATS
Who cannot join
- Patients who did not give consent
- Local anaesthetic allergy
- Known or suspected coagulopathy
- İnfection at the injection site
- History of thoracic surgery
- Severe cardiovascular disease
Show all 9Show fewer
- Hepatic or renal insufficiency (glomerular filtration rate <15 ml/min/1.73 m2)
- Severe neurological or psychiatric disorders
- Chronic opioid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparision of the Effects of Ultrasound-guided Erector Spinae Block and Combined Deep and Superficial Serratus Anterior Plane Block on Perioperative Analgesia for Video-assisted Thoracoscopic Surgery.
Objective: The authors hypothesized that combined deep and superficial serratus anterior plane block (SAPB) is as effective as erector spinae plane block (ESPB) for intraoperative and postoperative analgesia for video-assisted thoracoscopic surgery.
Design: A prospective randomized controlled study. Participants: Adult patients undergoing elective video-assisted thoracoscopic surgery.
Interventions: Preoperative SAPB or ESPB implementation.
Read the detailed description
Plane blocks implemented on preoperative course on 35 patients for each group. Postoperative Visual Analogue Scale (VAS) scores (0-10), intraoperative and postoperative analgesic consumption was measured using Mann-Whitney test. In the postoperative phase, opioid side effects, complications related to plane blocks, mobilization time and length of hospital stay was recorded and measured.
- Conditions
- Analgesia, Pain, Postoperative, Thoracic, Anesthesia
- Being tested
- erector spinae plane block, combined deep and superficial serratus anterior plane block
- Keywords
- serratus anterior plane block, video-assisted thoracoscopic surgery, erector spinae block, postoperative analgesia
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane blockProcedure or surgery
Erector spinae plane block was implemented on preoperative course on 35 patients. Intraoperative analgesic (Fentanyl) consumption was measured for intraoperative effects of the erector spinae plane block. Postoperative Visual Analogue Scale (VAS, from 0 to 10) scores and postoperative analgesic (Morphine) consumption was measured using Mann-Whitney test.
combined deep and superficial serratus anterior plane blockProcedure or surgery
Combined deep and superficial serratus anterior plane block was implemented on preoperative course on 35 patients. Intraoperative analgesic (Fentanyl) consumption was measured for intraoperative effects of the erector spinae plane block Postoperative Visual Analogue Scale (VAS, from 0 to 10) scores and postoperative analgesic (Morphine) consumption was measured using Mann-Whitney test.
| Study group | Role | What they receive |
|---|---|---|
| erector spinae plane block | Active comparator | Plane blocks implemented on preoperative course on 35 patients for group. Receives: Procedure: erector spinae plane block |
| combined deep and superficial serratus anterior plane block | Active comparator | Plane blocks implemented on preoperative course on 35 patients for group. Receives: Procedure: combined deep and superficial serratus anterior plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative analgesic effects
The primary outcome is compare the postoperative analgesic effects of SAPB and ESPB applied under USG guidance before surgery in patients scheduled for VATS using VAS (Visual Analogue Scale from 0 to 10).
Measured: first 48 hours
intraoperative analgesic effects
The primary outcome is compare the intraoperative analgesic effects of SAPB and ESPB applied under USG guidance before surgery in patients scheduled for VATS by measuring perioperative fentanyl consumption in both groups.
Measured: intraoperative phase
Secondary outcomes (4)
side effects
The secondary aim was to compare the opioid side effects. Patients were informed about opioid side effects and asked whether side effects were present.
Measured: first 48 hours
complications
The secondary aim was to compare the complications related to the applied block. Patients were examined and evaluated for any complications related to the block.
Measured: first 48 hours
mobilization
The secondary aim was to compare the mobilization time
Measured: first 48 hours
stay of hospital
length of stay in the recovery unit and hospital
Measured: first 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start2 Jul 2020
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Model description
- randomized, controlled
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Cansabuncu, Uludag University
- Investigators
- seda cansabuncu, Study chair, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073197
- Sponsor's protocol ID
- 2020-11/19
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision of the Effects of Ultrasound-guided Erector Spinae Block and Combined Deep and Superficial Serratus Anterior Plane Block on Perioperative Analgesia for Video-assisted Thoracoscopic Surgery.
- ClinicalTrials.gov ID
- NCT06073197
- Acronym / sponsor ID
- 2020-11/19
- Conditions
- Analgesia, Pain, Postoperative, Thoracic, Anesthesia
- Keywords
- serratus anterior plane block, video-assisted thoracoscopic surgery, erector spinae block, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 10 Oct 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.
Objective: The authors hypothesized that combined deep and superficial serratus anterior plane block (SAPB) is as effective as erector spinae plane block (ESPB) for intraoperative and postoperative analgesia for video-assisted thoracoscopic surgery.
Design: A prospective randomized controlled study. Participants: Adult patients undergoing elective video-assisted thoracoscopic surgery.
Interventions: Preoperative SAPB or ESPB implementation.
Detailed description
Plane blocks implemented on preoperative course on 35 patients for each group. Postoperative Visual Analogue Scale (VAS) scores (0-10), intraoperative and postoperative analgesic consumption was measured using Mann-Whitney test. In the postoperative phase, opioid side effects, complications related to plane blocks, mobilization time and length of hospital stay was recorded and measured.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, controlled
| Arm | Type | Receives |
|---|---|---|
| erector spinae plane block | Active comparator | Procedure: erector spinae plane blockPlane blocks implemented on preoperative course on 35 patients for group. |
| combined deep and superficial serratus anterior plane block | Active comparator | Procedure: combined deep and superficial serratus anterior plane blockPlane blocks implemented on preoperative course on 35 patients for group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anaesthesiologists (ASA) classification I-II scheduled for elective VATS
Key exclusion criteria (9 listed)
- Patients who did not give consent
- Local anaesthetic allergy
- Known or suspected coagulopathy
- İnfection at the injection site
- History of thoracic 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 |
|---|---|---|
| erector spinae plane blockErector spinae plane block was implemented on preoperative course on 35 patients. Intraoperative analgesic (Fentanyl) consumption was measured for intraoperative effects of the erector spinae plane block. Postoperative Visual Analogue Scale (VAS, from 0 to 10) scores and postoperative analgesic (Morphine) consumption was measured using Mann-Whitney test. | Procedure or surgery | erector spinae plane block |
| combined deep and superficial serratus anterior plane blockCombined deep and superficial serratus anterior plane block was implemented on preoperative course on 35 patients. Intraoperative analgesic (Fentanyl) consumption was measured for intraoperative effects of the erector spinae plane block Postoperative Visual Analogue Scale (VAS, from 0 to 10) scores and postoperative analgesic (Morphine) consumption was measured using Mann-Whitney test. | Procedure or surgery | combined deep and superficial serratus anterior plane block |
Primary outcome
postoperative analgesic effects
Time frame: first 48 hours
The primary outcome is compare the postoperative analgesic effects of SAPB and ESPB applied under USG guidance before surgery in patients scheduled for VATS using VAS (Visual Analogue Scale from 0 to 10).
intraoperative analgesic effects
Time frame: intraoperative phase
The primary outcome is compare the intraoperative analgesic effects of SAPB and ESPB applied under USG guidance before surgery in patients scheduled for VATS by measuring perioperative fentanyl consumption in both groups.
4 secondary outcomes
side effects
Time frame: first 48 hours
complications
Time frame: first 48 hours
mobilization
Time frame: first 48 hours
stay of hospital
Time frame: first 4 days
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 Oct 2023.
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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.
seda cansabuncu study chair
Uludag 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 erector spinae plane block and combined deep and superficial serratus anterior plane block in people with Analgesia and Pain, Postoperative, run by Uludag 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 9 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 Oct 2023. 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 analgesic effects (time frame: first 48 hours). The study lists 2 primary outcomes in all. 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 Oct 2023.