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Respiratory Function LossNCT06584201

Effects of Erector Spinae Plane Block and Paravertebral Block on Early Postoperative Pulmonary Function Test Parameters

A study testing Erector Spinae Plane Block (ESPB) and Paravertebral Block (PVB) in people with Respiratory Function Loss and Pain, Postoperative, run by Başakşehir Çam & Sakura City Hospital 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

The pain experienced by participants after minimally invasive chest surgery (VATS) can make it difficult for them to take deep breaths, which can lead to problems with lung function. This can cause serious problems such as lung collapse, low oxygen levels, and infections, making recovery longer and more difficult. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Erector Spinae Plane Block (ESPB) and Paravertebral Block (PVB)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2024to 30 Sep 2025
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

  • Both genders
  • Being between the ages of 18 and 65
  • ASA(American Society of Anesthesiologists) I-II-III
  • Body mass index between 19 and 35kg/m2
  • Providing voluntary participation
  • Must be fully oriented and able to cooperate

Who cannot join

  • ASA(American Society of Anesthesiologists) IV-V
  • Patients who refuse to participate in the study
  • Patients under 18 years of age
  • Patients over 65 years of age
  • Presence of active infection in the area to be treated
  • Chronic pain and constant analgesic use
Show all 12Show fewer
  • Patients with coagulation disorders
  • Patients who cannot cooperate with postoperative pain follow-ups
  • Cases taken urgently
  • Patients with severe renal failure (creatinine>2mg/dl)
  • Severe impairment of heart function (New York Heart Association Functional Classification III-IV)
  • Patients with known allergies to bupivacaine and other amide local anesthetic substances.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Basaksehir Çam Ve Sakura City Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Erector Spinae Plane Block and Paravertebral Block on Early Postoperative Pulmonary Function Test Parameters in Patients Undergoing Video-assisted Thoracoscopic Surgery

The pain experienced by participants after minimally invasive chest surgery (VATS) can make it difficult for them to take deep breaths, which can lead to problems with lung function. This can cause serious problems such as lung collapse, low oxygen levels, and infections, making recovery longer and more difficult. Managing pain well after surgery is important to prevent these problems and speed up recovery. In this study, we aimed to compare two pain relief methods, Erector Spinae Plane Block (ESP) and Paravertebral Block (PVB), in participants who underwent VATS. We will look at which method causes the smallest change in lung function before and after surgery.

Read the detailed description

Video-assisted Thoracoscopic surgery (VATS) is a minimally invasive surgical method used in the diagnosis and treatment of diseases in the chest area. Thoracoscopic surgery has many advantages, such as being less invasive, less risk of complications, shorter hospital stay, and better cosmetic results. However, these participants may experience severe pain in the postoperative period, although not as much as in surgeries performed with open surgical methods, that is, thoracotomy. This pain, which occurs in the postoperative period in VATS methods, which is one of the minimally invasive methods, may prevent the participants from taking deep breaths, as well as cause deterioration of respiratory functions, serious pulmonary complications such as atelectasis, hypoxia and infection, and prolonged postoperative patient stay. As the development of morbidity and mortality. Delay or deterioration in postoperative respiratory functions is one of the most troublesome complications of thoracic surgery. It was reported that acute pain in the postoperative period should be effectively controlled with effective analgesia methods in order to prevent postoperative pulmonary complications and accelerate the patient's well-being. Controlling pain with postoperative analgesia allows participants to breathe more deeply, perform breathing exercises more effectively, and therefore improves and helps preserve respiratory functions. Although thoracic epidural analgesia is the gold standard method in thoracic surgery, intravenous analgesic techniques and thoracic trunk nerve blocks are increasingly recommended for postoperative analgesia in less invasive VATS operations. Thoracic trunk blocks have effects on hemodynamics, respiratory functions, and consciousness; It has important advantages such as having fewer side effects than systemic analgesic techniques and being less invasive than thoracic epidural analgesia. Body blocks are recommended as a first-line analgesia program, especially in thoracic surgery, as they shorten postoperative recovery time, reduce the risk of pneumonia and provide early postoperative mobilization. The ease of application of the erector spinae plane block (ESP), its low risk of complications, and its ability to provide effective analgesia, especially in minimally invasive surgeries, have increased its use. Paravertebral block (PVB), one of the other blocks, is frequently used because it is more reliable and provides effective analgesia compared to thoracic epidural analgesia and conventional analgesia methods. Thoracic trunk plane blocks can significantly reduce intravenous opioid use and prevent side effects related to opioid use with the effective analgesia they provide in the early postoperative period, increase participants' comfort and painlessness, and accelerate recovery while preventing deterioration in respiratory function parameters. during rest and mobilization. Because; It is thought that by applying erector spinae plane block (ESP) or paravertebral block (PVB), postoperative pain scores and opioid consumption will decrease significantly and respiratory functions will return earlier. In this study, we aimed to evaluate the effects of ESP or PVB on respiratory functions in the early postoperative period in patients undergoing VATS, and in which block there would be less percentage change between preoperative and postoperative respiratory function test (PFT) parameters.

Pain is a symptom known to be subjective and will be queried with a standardized scale, the visual pain score scale (VAS), to minimize differences between participants. Postoperative rest and movement pain scores (VAS; 0, 1, 2, 4, 6, 12, 24 and pre-discharge scores), postoperative 6th hour, 12th hour and predischarge pulmonary function test (PFT) parameters, total Analgesic consumption will be recorded at 0, 1, 2, 4, 6, 12, 24 hours and before discharge.

Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 Second (FEV1), FEV1/FVC, Peak Expiratory Flow (PEF) values will be recorded as Respiratory Function Test parameters.

The total narcotic analgesic needs of the participants who received the block will be recorded with the PCA device placed intravenously postoperatively and their total Morphine consumption will be recorded.

Participants' satisfaction after the procedure will be questioned with a Likert score before discharge.

Side effects such as nausea and vomiting that may occur in participants will be questioned with the simplified post-operative nausea and vomiting impact scale.

Participants' demographic characteristics, comorbidities, operation times and complications will be recorded and statistically analyzed.

Being tested
Erector Spinae Plane Block (ESPB), Paravertebral Block (PVB)
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 Block (ESPB)Procedure or surgery

    The erector spinae plane block (ESPB) was performed before the VATS procedure under ultrasound guidance for postoperative analgesia. The block was performed using a standardized technique, with local anesthetic administered into the erector spinae plane.

  • Paravertebral Block (PVB)Procedure or surgery

    The paravertebral block (PVB) was performed before the VATS procedure under ultrasound guidance for postoperative analgesia. The block was performed using a standardized technique.

Study groups in NCT06584201
Study groupRoleWhat they receive
ESP GroupExperimentalPatients in this group received the erector spinae plane block (ESPB) as a method of postoperative pain management.
Receives: Procedure: Erector Spinae Plane Block (ESPB)
Paravertebral GroupActive comparatorPatients in this group received the paravertebral block (PVB) before the VATS procedure under ultrasound guidance for postoperative analgesia.
Receives: Procedure: Paravertebral Block (PVB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Forced Vital Capacity(FVC)

    Forced Vital Capacity (FVC) will be assessed using pulmonary function testing and reported in liters (L).

    Measured: Respiratory function tests will be performed 24 hours before surgery and at 0, 6, and 12 hours postoperatively, as well as before hospital discharge.

  2. Change in Forced Expiratory Volume in 1 Second (FEV1)

    Forced Expiratory Volume in 1 second (FEV1) will be assessed using pulmonary function testing and reported in liters (L).

    Measured: Respiratory function tests will be performed 24 hours before surgery and at 0, 6, and 12 hours postoperatively, as well as before hospital discharge.

  3. Change in Peak Expiratory Flow (PEF)

    Peak Expiratory Flow (PEF) will be assessed using pulmonary function testing and reported in liters per minute (L/min).

    Measured: Respiratory function tests will be performed 24 hours before surgery and at 0, 6, and 12 hours postoperatively, as well as before hospital discharge.

  4. Change in FEV1/FVC Ratio

    The FEV1/FVC ratio will be assessed using pulmonary function testing and reported as a percentage (%).

    Measured: Respiratory function tests will be performed 24 hours before surgery and at 0, 6, and 12 hours postoperatively, as well as before hospital discharge.

Secondary outcomes (4)
  1. Total Postoperative Morphine Consumption

    Total postoperative morphine consumption will be assessed as the cumulative dose of morphine administered during the 24-hour postoperative period and reported in milligrams (mg).

    Measured: From the end of surgery to 24 hours postoperatively.

  2. Number of Postoperative Morphine Boluses

    The number of postoperative morphine boluses administered during the 24-hour postoperative period will be recorded and reported as the number of boluses.

    Measured: From the end of surgery to 24 hours postoperatively.

  3. Postoperative Pain at Rest

    Postoperative pain at rest will be assessed using the Visual Analog Scale (VAS) at 0, 1, 4, 6, 12, and 24 hours after surgery.

    Measured: 0, 1, 4, 6, 12, and 24 hours after surgery.

  4. Postoperative Pain During Movement

    Postoperative pain during movement will be assessed using the Visual Analog Scale (VAS) at 0, 1, 4, 6, 12, and 24 hours after surgery.

    Measured: 0, 1, 4, 6, 12, and 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.

  1. First posted4 Sep 2024
  2. Study start1 Nov 2024
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

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
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06584201
Sponsor's protocol ID
E-96317027-514.10-222446069
Status last verified
Aug 2026
First submitted
9 Aug 2024
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Matyal R, Montealegre-Gallegos M, Shnider M, Owais K, Sakamuri S, Shakil O, Shah V, Pawlowski J, Gangadharan S, Hess P. Preemptive ultrasound-guided paravertebral block and immediate postoperative lung function. Gen Thorac Cardiovasc Surg. 2015 Jan;63(1):43-8. doi: 10.1007/s11748-014-0442-6. Epub 2014 Jul 1.

    PubMed 24980146
  • Detterbeck FC. Efficacy of methods of intercostal nerve blockade for pain relief after thoracotomy. Ann Thorac Surg. 2005 Oct;80(4):1550-9. doi: 10.1016/j.athoracsur.2004.11.051.

    PubMed 16181921
  • Gao W, Yang XL, Hu JC, Gu H, Wu XN, Hu SS, Wang S, Chai XQ, Wang D. Continuous Serratus Anterior Plane Block Improved Early Pulmonary Function After Lung Cancer Surgical Procedure. Ann Thorac Surg. 2022 Feb;113(2):436-443. doi: 10.1016/j.athoracsur.2021.02.032. Epub 2021 Mar 2.

    PubMed 33667460
  • Zengin M, Baldemir R, Ulger G, Sazak H, Alagoz A. Postoperative Analgesic Efficacy of Thoracic Paravertebral Block and Erector Spinae Plane Block Combination in Video-Assisted Thoracic Surgery. Cureus. 2021 Jun 12;13(6):e15614. doi: 10.7759/cureus.15614. eCollection 2021 Jun.

    PubMed 34277232

Questions about this trial

What is this clinical trial studying?

A study testing Erector Spinae Plane Block (ESPB) and Paravertebral Block (PVB) in people with Respiratory Function Loss and Pain, Postoperative, run by Başakşehir Çam & Sakura City Hospital 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 6 inclusion and 12 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 14 Sep 2026. 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?

Change in Forced Vital Capacity(FVC) (time frame: Respiratory function tests will be performed 24 hours before surgery and at 0, 6, and 12 hours postoperatively, as well as before hospital discharge.). The study lists 4 primary outcomes in all. 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 NCT06584201, which also lists 4 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 14 Sep 2026.

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