An interventional study of Erector Spinae Plane Block in Cholelithiasis, sponsored by Uludag University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Uludag University · Not applicable, Interventional, and Treatment
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.
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.
189 studies on the registry are indexed under Cholelithiasis; 42 are open to participants now.
This study's planned enrollment of 70 is below the median of 90 across 135 interventional studies indexed under Cholelithiasis.
Browse Cholelithiasis studies →Uludag University is the lead sponsor of 149 studies on the registry; 42 are open to participants now.
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Age between 18 and 65 years I-III-- III Patients scheduled for elective laparoscopic cholecystectomy under general anesthesia Ability to perform spirometry tests Provision of written
Exclusion Criteria:
Patient refusal to participate Chronic pulmonary disease (e.g., , asthma, restrictive lung disease) Morbid obesity ( ≥ 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing elective laparoscopic cholecystectomy who will receive bilateral ultrasound-guided erector spinae plane block in addition to standard general anesthesia for postoperative analgesia.
Procedure: Erector Spinae Plane Block
Patients undergoing elective laparoscopic cholecystectomy who will receive standard general anesthesia and postoperative analgesic management without erector spinae plane block.
Ultrasound-guided bilateral erector spinae plane block performed at the thoracic level following induction of general anesthesia to provide postoperative thoracoabdominal analgesia.
Change in Forced Expiratory Volume in 1 Second (FEV1)
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.
Time frame: Preoperative, postoperative 6 hours, and postoperative 24 hours
Change in Forced Vital Capacity (FVC)
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.
Time frame: Preoperative baseline, postoperative 6 hours, and postoperative 24 hours
Change in FEV1/FVC Ratio
The FEV1/FVC ratio will be assessed using spirometry to evaluate postoperative ventilatory function and will be compared between study groups.
Time frame: Preoperative baseline, postoperative 6 hours, and postoperative 24 hours
Change in Forced Expiratory Flow 25-75% (FEF25-75)
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.
Time frame: Preoperative baseline, postoperative 6 hours, and postoperative 24 hours
Change in Arterial Blood Gas Parameters
Arterial blood gas analysis will be performed to evaluate perioperative respiratory status. Parameters including pH, PaO2, and PaCO2 will be compared between groups.
Time frame: Preoperative baseline and postoperative 6 hours
Postoperative Pain Intensity (VAS)
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.
Time frame: Postoperative 1 hour, 6 hours, and 24 hours
Postoperative Analgesic Consumption
Total postoperative analgesic consumption will be recorded and compared between study groups.
Time frame: Within the first 24 hours after surgery
Plan to share: No — Individual participant data will not be publicly shared due to institutional data protection policies and ethical considerations regarding patient confidentiality
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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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