Video-Assisted Thoracoscopic SurgeryNCT05334628
The Effect of ESPB on Intraoperative Hemodynamics in VATS
A study testing Preoperative Erector spinae plane block and Postperative Erector spinae plane block in people with Video-Assisted Thoracoscopic Surgery and Erector Spinae Plane Block, run by Ankara City Hospital Bilkent at 2 sites in Turkey (Türkiye).
Trial summary
Video-assisted thoracic surgery (VATS) is frequently applied in thoracic surgery operations. VATS has become the standard procedure in minor and major lung surgeries. In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Video-Assisted Thoracoscopic Surgery, Erector Spinae Plane Block, Mean Arterial Pressure
- What is being tested?
- Preoperative Erector spinae plane block and Postperative Erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 11 Apr 2022to 12 Oct 2022
- 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
- Age between 18 and 80 years
- American Society of Anesthesiologists physical status I-II-III
- Body mass index between 18-40 kg/m2
- Patients undergoing elective video assisted thoracoscopic surgery
Who cannot join
- Advanced cancer
- History of chronic analgesic therapy
- History of local anesthetic allergy
- Infection in the intervention area
- Patients with bleeding disorders
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara City Hospital
Çankaya, Ankara, 06290
Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
Keçiören, Ankara, 06290
About this study
Official title: The Effect of Erector Spinae Plane Block on Intraoperative Hemodynamics in Video-Assisted Thoracoscopic Surgery
Video-assisted thoracic surgery (VATS) is frequently applied in thoracic surgery operations. VATS has become the standard procedure in minor and major lung surgeries. In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Thoracic paravertebral block (TPVB), erector spinae plane block (ESPB), and serratus anterior plane block (SAPB) are also among the regional anesthesia techniques frequently used in thoracic surgery.
General anesthesia (GA) is the main method of anesthesia for thoracic surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as TPVB, ESPB, and SAPB, more stable hemodynamics is expected by providing preemptive analgesia in patients. As a result of all these; In this study, we aimed to compare the intraoperative hemodynamic changes of patients who underwent preoperative ESPB in patients who will undergo VATS resection under GA with those who underwent postoperative ESPB.
- Conditions
- Video-Assisted Thoracoscopic Surgery, Erector Spinae Plane Block, Mean Arterial Pressure, Heart Rate
- Being tested
- Preoperative Erector spinae plane block, Postperative Erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Erector spinae plane blockProcedure or surgery
Erector spinae plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position.
Postperative Erector spinae plane blockProcedure or surgery
Erector spinae plane block will be performed unilaterally, under US guidance, after the surgical operation, under general anesthesia, and when the patient is placed in the lateral decubitus position.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Erector Spinae Plane Block | Active comparator | In the preoperative period, under general anesthesia, after the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 30 ml of 0.25% bupivacaine hydrochloride will be injected into the interfacial space below the erector spinae muscle, above the transverse process. Receives: Procedure: Preoperative Erector spinae plane block |
| Postperative Erector Spinae Plane Block | Active comparator | In the postoperative period, under general anesthesia, after the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 30 ml of 0.25% bupivacaine hydrochloride will be injected into the interfacial space below the erector spinae muscle, above the transverse process. Receives: Procedure: Postperative Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure
Mean arterial pressure values will be recorded before anesthesia, before surgical incision, after surgical incision at 5th, 30th, 60th, 90th, 120th minutes, and after general anesthesia.
Measured: Perioperative period
Heart rate
Heart rate values will be recorded before anesthesia, before surgical incision, after surgical incision at 5th, 30th, 60th, 90th, 120th minutes, and after general anesthesia.
Measured: Perioperative period
Secondary outcomes (1)
Pain scores
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at the 1st, 2nd, 4th, 12th, and 24th hours after surgery.
Measured: First 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start11 Apr 2022
- Primary completion12 Sep 2022
- Study completion12 Oct 2022
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.
- More trials run by Ankara City Hospital BilkentThe 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgün Zengin, Ankara City Hospital Bilkent
- Investigators
- Nilgün Zengin, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334628
- Sponsor's protocol ID
- E.Kurul-E1-22-2536
- Status last verified
- Oct 2022
- First submitted
- 11 Apr 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Erector Spinae Plane Block on Intraoperative Hemodynamics in Video-Assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT05334628
- Acronym / sponsor ID
- E.Kurul-E1-22-2536
- Conditions
- Video-Assisted Thoracoscopic Surgery, Erector Spinae Plane Block, Mean Arterial Pressure, Heart Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 19 Apr 2022 (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.
Video-assisted thoracic surgery (VATS) is frequently applied in thoracic surgery operations. VATS has become the standard procedure in minor and major lung surgeries. In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Thoracic paravertebral block (TPVB), erector spinae plane block (ESPB), and serratus anterior plane block (SAPB) are also among the regional anesthesia techniques frequently used in thoracic surgery.
General anesthesia (GA) is the main method of anesthesia for thoracic surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as TPVB, ESPB, and SAPB, more stable hemodynamics is expected by providing preemptive analgesia in patients. As a result of all these; In this study, we aimed to compare the intraoperative hemodynamic changes of patients who underwent preoperative ESPB in patients who will undergo VATS resection under GA with those who underwent postoperative ESPB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative Erector Spinae Plane Block | Active comparator | Procedure: Preoperative Erector spinae plane blockIn the preoperative period, under general anesthesia, after the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 30 ml of 0.25% bupivacaine hydrochloride will be injected into the interfacial space below the erector spinae muscle, above the transverse process. |
| Postperative Erector Spinae Plane Block | Active comparator | Procedure: Postperative Erector spinae plane blockIn the postoperative period, under general anesthesia, after the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 30 ml of 0.25% bupivacaine hydrochloride will be injected into the interfacial space below the erector spinae muscle, above the transverse process. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years
- American Society of Anesthesiologists physical status I-II-III
- Body mass index between 18-40 kg/m2
- Patients undergoing elective video assisted thoracoscopic surgery
Key exclusion criteria (5 listed)
- Advanced cancer
- History of chronic analgesic therapy
- History of local anesthetic allergy
- Infection in the intervention area
- Patients with bleeding disorders
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 |
|---|---|---|
| Preoperative Erector spinae plane blockErector spinae plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position. | Procedure or surgery | Preoperative Erector Spinae Plane Block |
| Postperative Erector spinae plane blockErector spinae plane block will be performed unilaterally, under US guidance, after the surgical operation, under general anesthesia, and when the patient is placed in the lateral decubitus position. | Procedure or surgery | Postperative Erector Spinae Plane Block |
Primary outcome
Mean arterial pressure
Time frame: Perioperative period
Mean arterial pressure values will be recorded before anesthesia, before surgical incision, after surgical incision at 5th, 30th, 60th, 90th, 120th minutes, and after general anesthesia.
Heart rate
Time frame: Perioperative period
Heart rate values will be recorded before anesthesia, before surgical incision, after surgical incision at 5th, 30th, 60th, 90th, 120th minutes, and after general anesthesia.
1 secondary outcome
Pain scores
Time frame: First 24 hours after surgery
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 13 Oct 2022.
- 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.
Nilgün Zengin, MD principal investigator
Ankara City Hospital Bilkent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Erector spinae plane block and Postperative Erector spinae plane block in people with Video-Assisted Thoracoscopic Surgery and Erector Spinae Plane Block, run by Ankara City Hospital Bilkent at 2 sites 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 4 inclusion and 5 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 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Mean arterial pressure (time frame: Perioperative period). 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 13 Oct 2022.