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Completed

NCT Number: NCT06584201

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Basaksehir Çam Ve Sakura City Hospital

Istanbul, Turkey (Türkiye)

About this study

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, 24th 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both genders
  • Being between the ages of 18 and 65
  • ASA(American Society of Anesthesiologists) I-II-III
  • Body mass index between 19 and 30kg/m2
  • Providing voluntary participation
  • Must be fully oriented and able to cooperate

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Erector spinae plane block (ESPB)

Procedure

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

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

Primary outcomes

  1. 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.

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

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

    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.

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

  3. Change in Peak Expiratory Flow (PEF)

    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.

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

  4. Change in FEV1/FVC Ratio

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

Secondary outcomes

  1. Total Postoperative Morphine Consumption

    Time frame: From the end of surgery to 24 hours postoperatively.

    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).

  2. Number of Postoperative Morphine Boluses

    Time frame: From the end of surgery to 24 hours postoperatively.

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

  3. Postoperative Pain at Rest

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

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

  4. Postoperative Pain During Movement

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

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

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2024
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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