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NCT Number: NCT07478601

Effect of Erector Spinae Plane Block on Postoperative Respiratory Function After Laparoscopic Cholecystectomy

Postoperative pulmonary dysfunction is frequently observed after laparoscopic abdominal surgery due to the combined effects of general anesthesia, pneumoperitoneum, diaphragmatic dysfunction, and postoperative pain. These factors may impair respiratory mechanics, reduce lung volumes, and negatively affect postoperative recovery. Effective postoperative analgesia plays a crucial role in preserving respiratory function by allowing adequate ventilation and reducing pain-related respiratory limitation.

The erector spinae plane (ESP) block is a relatively novel ultrasound-guided fascial plane block that provides thoracoabdominal analgesia through the spread of local anesthetic along the paraspinal fascial planes. By reducing postoperative pain and opioid consumption, ESP block may contribute to improved respiratory mechanics and preservation of postoperative pulmonary function.

The aim of this prospective randomized controlled study is to evaluate the effect of ultrasound-guided erector spinae plane block on postoperative respiratory function and pain in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomized into two groups: an ESP block group receiving bilateral ultrasound-guided erector spinae plane block and a control group receiving standard analgesic management.

Postoperative respiratory parameters will be evaluated using spirometry measurements including forced expiratory volume in one second (FEV1), forced vital capacity (FVC), the FEV1/FVC ratio, and forced expiratory flow at 25-75% of the pulmonary volume (FEF25-75). In addition, arterial blood gas parameters and postoperative pain scores will be assessed and compared between the groups.

The study aims to determine whether ultrasound-guided erector spinae plane block improves postoperative respiratory function and contributes to better postoperative recovery in patients undergoing laparoscopic cholecystectomy.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Uludağ University Faculty of Medicine Hospital

Bursa, 16059, Turkey (Türkiye)

Location contact

Mahsa Azizi, MD

SUB_INVESTIGATOR

Selcan Akesen, Associate Professor, MD

CONTACT

[email protected]

0090224 2950000

Selcan Akesen, Associate Professor, MD

PRINCIPAL_INVESTIGATOR

About this study

Postoperative pulmonary dysfunction is a common complication following laparoscopic abdominal surgery. Several factors contribute to this condition, including the effects of general anesthesia, diaphragmatic dysfunction caused by pneumoperitoneum, decreased functional residual capacity, and postoperative pain that limits effective ventilation and coughing. These mechanisms may lead to reduced lung volumes, impaired respiratory mechanics, and an increased risk of postoperative pulmonary complications.

Adequate postoperative analgesia is a key component of perioperative care because pain following upper abdominal surgery may inhibit deep breathing and reduce chest wall expansion. As a result, insufficient analgesia can further aggravate postoperative respiratory dysfunction. Regional anesthesia techniques have therefore gained increasing interest in multimodal analgesic strategies to improve postoperative outcomes.

The erector spinae plane (ESP) block is a relatively recent ultrasound-guided fascial plane block that involves injection of local anesthetic into the fascial plane deep to the erector spinae muscle. The spread of local anesthetic along the thoracolumbar fascia allows analgesic coverage of multiple thoracic dermatomes and provides effective thoracoabdominal analgesia. Previous studies have demonstrated that ESP block can reduce postoperative pain scores and opioid consumption in various abdominal and thoracic surgical procedures.

Improved postoperative analgesia may also contribute to better preservation of respiratory mechanics. By reducing pain during breathing and coughing, ESP block may facilitate deeper inspiration, improve lung expansion, and support the maintenance of postoperative pulmonary function. However, the effect of ESP block on objective respiratory function parameters following laparoscopic cholecystectomy has not been fully clarified.

This prospective randomized controlled study aims to evaluate the effect of ultrasound-guided erector spinae plane block on postoperative respiratory function and pain in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomly assigned to either an ESP block group or a control group receiving standard analgesic management.

Postoperative respiratory function will be assessed using spirometry measurements, including forced expiratory volume in one second (FEV1), forced vital capacity (FVC), the FEV1/FVC ratio, and forced expiratory flow between 25% and 75% of the pulmonary volume (FEF25-75). Arterial blood gas parameters will also be evaluated. Pain intensity will be assessed using the visual analog scale (VAS), and postoperative analgesic consumption will be recorded.

The primary objective of this study is to determine whether ultrasound-guided erector spinae plane block preserves postoperative respiratory function after laparoscopic cholecystectomy. Secondary objectives include evaluation of postoperative pain scores, analgesic requirements, and arterial blood gas parameters.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age between 18 and 65 years ASA physical status I-III-- III Patients scheduled for elective laparoscopic cholecystectomy under general anesthesia Ability to perform spirometry tests Provision of written informed consent

Exclusion criteria

Patient refusal to participate Chronic pulmonary disease (e.g., COPD, asthma, restrictive lung disease) Morbid obesity (BMI ≥ 35 kg/m²) Coagulopathy or anticoagulant therapy Local infection at the block site Allergy to local anesthetic agents Pregnancy Previous thoracic surgery Neuromuscular disease affecting respiratory function Conversion from laparoscopic to open surgery Inability to perform postoperative spirometry

Treatment and study plan

Erector Spinae Plane Block

Procedure

Ultrasound-guided bilateral erector spinae plane block performed at the thoracic level following induction of general anesthesia to provide postoperative thoracoabdominal analgesia.

Primary outcomes

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

    Time frame: Preoperative, postoperative 6 hours, and postoperative 24 hours

    Postoperative respiratory function will be assessed by spirometry measurement of forced expiratory volume in 1 second (FEV1). Changes in FEV1 from baseline will be compared between the ultrasound-guided erector spinae plane block group and the control group in patients undergoing elective laparoscopic cholecystectomy.

  2. Change in Forced Vital Capacity (FVC)

    Time frame: Preoperative baseline, postoperative 6 hours, and postoperative 24 hours

    Forced vital capacity (FVC) will be measured by spirometry to evaluate postoperative respiratory function. Changes in FVC from baseline will be compared between the erector spinae plane block group and the control group.

Secondary outcomes

  1. Change in FEV1/FVC Ratio

    Time frame: Preoperative baseline, postoperative 6 hours, and postoperative 24 hours

    The FEV1/FVC ratio will be assessed using spirometry to evaluate postoperative ventilatory function and will be compared between study groups.

  2. Change in Forced Expiratory Flow 25-75% (FEF25-75)

    Time frame: Preoperative baseline, postoperative 6 hours, and postoperative 24 hours

    Forced expiratory flow between 25% and 75% of forced vital capacity (FEF25-75) will be measured by spirometry to evaluate small airway function and compared between the erector spinae plane block group and the control group.

  3. Change in Arterial Blood Gas Parameters

    Time frame: Preoperative baseline and postoperative 6 hours

    Arterial blood gas analysis will be performed to evaluate perioperative respiratory status. Parameters including pH, PaO2, and PaCO2 will be compared between groups.

  4. Postoperative Pain Intensity (VAS)

    Time frame: Postoperative 1 hour, 6 hours, and 24 hours

    Postoperative pain intensity will be assessed using the visual analog scale (VAS). Pain scores will be compared between the erector spinae plane block group and the control group.

  5. Postoperative Analgesic Consumption

    Time frame: Within the first 24 hours after surgery

    Total postoperative analgesic consumption will be recorded and compared between study groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Selcan Akesen, Assoc. Prof. MD

CONTACT

[email protected]

00902242953274

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Pain and Respiratory Function in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study

Acronym: ESP-LC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
Mar 17, 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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