Pain, PostoperativeESPBTEAPAINNCT05402917
Comparison of the Efficacy of Erector Spina Plane Block and Thoracic Epidural Analgesia After Thoracotomy
An observational study of Pain, Postoperative, run by Mesut Aslan at 1 site in Turkey (Türkiye).
Trial summary
In patients who undergoing lobectomy with thoracotomy incision, the effectiveness of erector spina plane block in post-operative analgesia management is at least as much as thoracic epidural anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Jan 2023
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing lobectomy with thoracotomy incision
Who may be able to join
- Lobectomy planned with thoracotomy incision;
- Adult aged 18-75;
- American Society of Anesthesiology(ASA) score1-3.
Who cannot join
- Obesity (BMI greater than 35 kg/m2)
- Local infection at the injection site,
- Presence of known coagulopathy
- Bone or brain metastasis
- Having impaired liver or kidney function
- Patients who cannot evaluate VAS as cognitive function
Show all 10Show fewer
- Patients who cannot use the Patient-Controlled Analgesia (PCA) pump as a -cognitive function
- History of chronic pain medication use
- Allergy to the drugs to be used in the study
- Withdrawing consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul
About this study
Official title: Comparison of Post-operative Analgesia Efficacy of Erector Spina Plan Block (ESPB) and Thoracic Epidural Analgesia (TEA) in Patients Undergoing Lobectomy With Thoracotomy Incision
In patients who undergoing lobectomy with thoracotomy incision, the effectiveness of erector spina plane block in post-operative analgesia management is at least as much as thoracic epidural anesthesia.
Read the detailed description
Observational recording of the data was planned by dividing the patients who met the internal criteria of the study and whose written and verbal consents were obtained for the study, into two groups as the patients applied ESPB or TEA. ESPB and TEA are applied to patients in our clinic depending on the preference of the physician. The routine procedures in ESPB and TEA are described in groups part. For this study, no procedure or intervention other than this routine will be performed, and the research will be conducted observationally.
Anesthesia induction for both groups will be performed with standard monitors, electrocardiogram, peripheral oxygen saturation probe and non-invasive automatic blood pressure/invasive arterial monitoring in the operating room. Anesthesia induction will be performed with 2 mg/kg propofol, 2 mcg/kg fentanyl and 0.6 mg/kg rocuronium with 1.5 mg/kg IV lidocaine, followed by double lumen endotracheal intubation and positive pressure mechanical ventilation with controlled positive 50% inspired oxygen. Ventilation parameters will be adjusted to keep end-tidal carbon dioxide around 35 mmHg. Anesthesia will be maintained with end-tidal sevoflurane 0.7-1.5 minimum alveolar concentration (adjusted for hemodynamics) 0.15 mg/kg rocuronium and 0.05-0.2 mcg/kg/min remifentanil (adjusted for hemodynamics). Acetaminophen (1 g paracetamol) IV will be administered to all patients 30 minutes before the end of surgery.
Blood pressure, peripheral oxygen saturation, heart rate, end-pulmonary carbon dioxide value and mac value of the patients will be recorded before and after block application, before and after anesthesia induction, every 15 minutes in the first hour and every 30 minutes after the first hour. Patients will be extubated with 0.03 mg/kg atropine and 0.07 mg/kg neostigmine at the end of surgery. Hemodynamic and resting Visual Analogue Scale (VAS) values for both groups taken to the post-operative intensive care unit will be recorded by nurse or anesthesia assistant at 0,2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit. In combination with the numerical pain scale, the Wong-Baker face pain scale (FS) will be used for the postoperative pain assessment of the patient. The pain assessment form will have six faces representing pain along with numbers 0 to 10, with 0 for no pain and 10 for being unbearable pain. Post-operative nausea, vomiting and any complications related to the block will be reported. Patients in the two groups will be evaluated with the VAS score for the pain they describe and record; VAS 0-4 will be classified as mild, VAS 5-7 as moderate, VAS 8-10 as severe pain. In patients with VAS >4, additional analgesia will be given with IV non-steroidal anti-inflammatory drugs (20 mg tenoxicam); after 30 minutes, VAS scoring will be evaluated again and IV tramadol 2 mg/kg (not to exceed a maximum of 100 mg once and not to exceed a maximum of 400 mg daily) will be administered in addition to patients with VAS>4. Additional analgesia amounts and hours used will be recorded.
- Conditions
- Pain, Postoperative
- Being tested
- Erector Spinae Plane Block
- Keywords
- ESPB, TEA, THORACOTOMY
- Medical subject headings
- 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
Interfascial plane (area) blocks are blocks in which the local anesthetic agent is injected into the potential area between the two fasciae. The ESPB we used in our study is a member of interfascial plane blocks. The erector is applied between the spinal muscle and the transverse process, spreading the drug from the injection site to both cranial and caudal. Unlike other defined interfascial plane blocks, ESPB can show paraspinal block characteristics since the injection site is above the transverse process.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Epidural Analgesia (TEA) | For patients undergoing TEA is done under general anesthesia after surgery procedure.Once the catheter is secured, a bolus dose of 15 ml of 0.25% bupivacaine will be administered as an epidural injection through the catheter, followed by a continuous infusion of 0.125% bupivacaine at a rate of 0.1 mL/kg/h for the postoperative 24-hour period. | |
| Erector Spina Plan Block (ESPB) | For patients undergoing ESPB is done under general anesthesia after surgery procedure.A bolus dose of 15 mL of 0.25% bupivacaine will be administered from the inserted catheter. Subsequently, 0.125% bupivacaine will be given continuously at a rate of 0.1 mL/kg/h for up to 24 hours post-operatively. Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) Change
The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: The first 24 hours postoperatively is the end time for primary outcome measurement.Visual Analogue Scale (VAS) change values for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.
Wong-Baker Face Pain Scale (FS) Change
The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable.
Measured: The first 24 hours postoperatively is the end time for primary outcome measurement.Wong-Baker Face Pain Scale(FS) values change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.
Secondary outcomes (5)
Hemodynamic Values Change
Blood Pressure: mmhg Heart Rate: beat/minute
Measured: The first 24 hours postoperatively is the end time for secondary outcome measurement. Hemodynamic values change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.
Pulse Oximetry(SpO2) Change
%0-100.
Measured: The first 24 hours postoperatively is the end time for secondary outcome measurement. Pulse Oximetry(SpO2) change values for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.
Postoperative Nausea and Vomiting(PONV) Change
If nausea and vomiting exist, it will be recorded as '1', if not, it will be recorded as '0'.
Measured: The first 24 hours postoperatively is the end time for secondary outcome measurement. Postoperative nausea or vomiting change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.
Nonsteroidal Anti-inflammatory Drug Usage Need Change
If nonsteroidal anti-inflammatory drug is used: 1 If nonsteroidal anti-inflammatory drug is not used: 0
Measured: The first 24 hours postoperatively is the end time for secondary outcome measurement. Nonsteroidal anti-inflammatory drug usage need change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.
Opioid Drug Usage Need Change
If opioid drug is used: 1 If opioid drug is not used: 0
Measured: The first 24 hours postoperatively is the end time for secondary outcome measurement. Opioid drug usage need change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Feb 2022
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesut Aslan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mesut Aslan, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402917
- Sponsor's protocol ID
- espVStea
- Acronym
- ESPBTEAPAIN
- Status last verified
- May 2024
- First submitted
- 25 May 2022
- Last updated
- 7 May 2024
- 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operative Analgesia Efficacy of Erector Spina Plan Block (ESPB) and Thoracic Epidural Analgesia (TEA) in Patients Undergoing Lobectomy With Thoracotomy Incision
- ClinicalTrials.gov ID
- NCT05402917
- Acronym / sponsor ID
- ESPBTEAPAIN / espVStea
- Conditions
- Pain, Postoperative
- Keywords
- ESPB, TEA, THORACOTOMY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mesut AslanUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 2 Jun 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.
In patients who undergoing lobectomy with thoracotomy incision, the effectiveness of erector spina plane block in post-operative analgesia management is at least as much as thoracic epidural anesthesia.
Detailed description
Observational recording of the data was planned by dividing the patients who met the internal criteria of the study and whose written and verbal consents were obtained for the study, into two groups as the patients applied ESPB or TEA. ESPB and TEA are applied to patients in our clinic depending on the preference of the physician. The routine procedures in ESPB and TEA are described in groups part. For this study, no procedure or intervention other than this routine will be performed, and the research will be conducted observationally.
Anesthesia induction for both groups will be performed with standard monitors, electrocardiogram, peripheral oxygen saturation probe and non-invasive automatic blood pressure/invasive arterial monitoring in the operating room. Anesthesia induction will be performed with 2 mg/kg propofol, 2 mcg/kg fentanyl and 0.6 mg/kg rocuronium with 1.5 mg/kg IV lidocaine, followed by double lumen endotracheal intubation and positive pressure mechanical ventilation with controlled positive 50% inspired oxygen. Ventilation parameters will be adjusted to keep end-tidal carbon dioxide around 35 mmHg. Anesthesia will be maintained with end-tidal sevoflurane 0.7-1.5 minimum alveolar concentration (adjusted for hemodynamics) 0.15 mg/kg rocuronium and 0.05-0.2 mcg/kg/min remifentanil (adjusted for hemodynamics). Acetaminophen (1 g paracetamol) IV will be administered to all patients 30 minutes before the end of surgery.
Blood pressure, peripheral oxygen saturation, heart rate, end-pulmonary carbon dioxide value and mac value of the patients will be recorded before and after block application, before and after anesthesia induction, every 15 minutes in the first hour and every 30 minutes after the first hour. Patients will be extubated with 0.03 mg/kg atropine and 0.07 mg/kg neostigmine at the end of surgery. Hemodynamic and resting Visual Analogue Scale (VAS) values for both groups taken to the post-operative intensive care unit will be recorded by nurse or anesthesia assistant at 0,2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit. In combination with the numerical pain scale, the Wong-Baker face pain scale (FS) will be used for the postoperative pain assessment of the patient. The pain assessment form will have six faces representing pain along with numbers 0 to 10, with 0 for no pain and 10 for being unbearable pain. Post-operative nausea, vomiting and any complications related to the block will be reported. Patients in the two groups will be evaluated with the VAS score for the pain they describe and record; VAS 0-4 will be classified as mild, VAS 5-7 as moderate, VAS 8-10 as severe pain. In patients with VAS >4, additional analgesia will be given with IV non-steroidal anti-inflammatory drugs (20 mg tenoxicam); after 30 minutes, VAS scoring will be evaluated again and IV tramadol 2 mg/kg (not to exceed a maximum of 100 mg once and not to exceed a maximum of 400 mg daily) will be administered in addition to patients with VAS>4. Additional analgesia amounts and hours used will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Epidural Analgesia (TEA) | – | –For patients undergoing TEA is done under general anesthesia after surgery procedure.Once the catheter is secured, a bolus dose of 15 ml of 0.25% bupivacaine will be administered as an epidural injection through the catheter, followed by a continuous infusion of 0.125% bupivacaine at a rate of 0.1 mL/kg/h for the postoperative 24-hour period. |
| Erector Spina Plan Block (ESPB) | – | Procedure: Erector Spinae Plane BlockFor patients undergoing ESPB is done under general anesthesia after surgery procedure.A bolus dose of 15 mL of 0.25% bupivacaine will be administered from the inserted catheter. Subsequently, 0.125% bupivacaine will be given continuously at a rate of 0.1 mL/kg/h for up to 24 hours post-operatively. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lobectomy with thoracotomy incision
Key inclusion criteria (3 listed)
- Lobectomy planned with thoracotomy incision;
- Adult aged 18-75;
- American Society of Anesthesiology(ASA) score1-3.
Key exclusion criteria (10 listed)
- Obesity (BMI greater than 35 kg/m2)
- Local infection at the injection site,
- Presence of known coagulopathy
- Bone or brain metastasis
- Having impaired liver or kidney function
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 BlockInterfascial plane (area) blocks are blocks in which the local anesthetic agent is injected into the potential area between the two fasciae. The ESPB we used in our study is a member of interfascial plane blocks. The erector is applied between the spinal muscle and the transverse process, spreading the drug from the injection site to both cranial and caudal. Unlike other defined interfascial plane blocks, ESPB can show paraspinal block characteristics since the injection site is above the transverse process. | Procedure or surgery | Erector Spina Plan Block (ESPB) |
Primary outcome
Visual Analogue Scale (VAS) Change
Time frame: The first 24 hours postoperatively is the end time for primary outcome measurement.Visual Analogue Scale (VAS) change values for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.
The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Wong-Baker Face Pain Scale (FS) Change
Time frame: The first 24 hours postoperatively is the end time for primary outcome measurement.Wong-Baker Face Pain Scale(FS) values change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.
The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable.
5 secondary outcomes
Hemodynamic Values Change
Time frame: The first 24 hours postoperatively is the end time for secondary outcome measurement. Hemodynamic values change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.
Pulse Oximetry(SpO2) Change
Time frame: The first 24 hours postoperatively is the end time for secondary outcome measurement. Pulse Oximetry(SpO2) change values for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.
Postoperative Nausea and Vomiting(PONV) Change
Time frame: The first 24 hours postoperatively is the end time for secondary outcome measurement. Postoperative nausea or vomiting change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.
Nonsteroidal Anti-inflammatory Drug Usage Need Change
Time frame: The first 24 hours postoperatively is the end time for secondary outcome measurement. Nonsteroidal anti-inflammatory drug usage need change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.
Opioid Drug Usage Need Change
Time frame: The first 24 hours postoperatively is the end time for secondary outcome measurement. Opioid drug usage need change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.
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 7 May 2024.
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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?
An observational study of Pain, Postoperative, run by Mesut Aslan 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 10 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 7 May 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?
Visual Analogue Scale (VAS) Change (time frame: The first 24 hours postoperatively is the end time for primary outcome measurement.Visual Analogue Scale (VAS) change values for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.). 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 7 May 2024.