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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05402917
Study groupRoleWhat 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.

  1. 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.

  2. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  1. First posted2 Jun 2022
  2. Study start1 Feb 2022
  3. Primary completion1 Dec 2022
  4. Study completion1 Jan 2023

Resources

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)
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

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.

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