- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07478601
Effect of Erector Spinae Plane Block on Postoperative Respiratory Function After Laparoscopic Cholecystectomy (ESP-LC)
Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Pain and Respiratory Function in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Selcan Akesen, Assoc. Prof. MD
- Phone Number: 00902242953274
- Email: selcanakesen@uludag.edu.tr
Study Locations
-
-
Bursa
-
Bursa, Bursa, Turkey (Türkiye), 16059
- Bursa Uludağ University Faculty of Medicine Hospital
-
Contact:
- Selcan Akesen, Associate Professor, MD
- Phone Number: 0090224 2950000
- Email: selcanakesen@uludag.edu.tr
-
Principal Investigator:
- Selcan Akesen, Associate Professor, MD
-
Sub-Investigator:
- Mahsa Azizi, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ESP Block Group
Patients undergoing elective laparoscopic cholecystectomy who will receive bilateral ultrasound-guided erector spinae plane block in addition to standard general anesthesia for postoperative analgesia.
|
Ultrasound-guided bilateral erector spinae plane block performed at the thoracic level following induction of general anesthesia to provide postoperative thoracoabdominal analgesia.
|
|
No Intervention: Control Group
Patients undergoing elective laparoscopic cholecystectomy who will receive standard general anesthesia and postoperative analgesic management without erector spinae plane block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Preoperative, postoperative 6 hours, and postoperative 24 hours
|
|
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.
|
Preoperative baseline, postoperative 6 hours, and postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Preoperative baseline, postoperative 6 hours, and postoperative 24 hours
|
|
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.
|
Preoperative baseline, postoperative 6 hours, and postoperative 24 hours
|
|
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.
|
Preoperative baseline and postoperative 6 hours
|
|
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.
|
Postoperative 1 hour, 6 hours, and 24 hours
|
|
Postoperative Analgesic Consumption
Time Frame: Within the first 24 hours after surgery
|
Total postoperative analgesic consumption will be recorded and compared between study groups.
|
Within the first 24 hours after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESP-LC-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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