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

NCT07478601 | Not Yet Recruiting DMC

• 1 other identifier: ESP-LC-2026
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholelithiasis

Keywords

Cholelithiasis; Erector Spinae Plane Block; Postoperative Respiratory Function; Laparoscopic Cholecystectomy; Postoperative Pain; Regional Anesthesia; Spirometry

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Preoperative baseline, postoperative 6 hours, and postoperative 24 hours

Secondary Outcomes (5)

• Change in FEV1/FVC Ratio

  Preoperative baseline, postoperative 6 hours, and postoperative 24 hours

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

  Preoperative baseline, postoperative 6 hours, and postoperative 24 hours

• Change in Arterial Blood Gas Parameters

  Preoperative baseline and postoperative 6 hours

• Postoperative Pain Intensity (VAS)

  Postoperative 1 hour, 6 hours, and 24 hours

• Postoperative Analgesic Consumption

  Within the first 24 hours after surgery

Study Arms (2)

ESP Block Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Patients undergoing elective laparoscopic cholecystectomy who will receive standard general anesthesia and postoperative analgesic management without erector spinae plane block.

Interventions

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.

ESP Block Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludağ University Faculty of Medicine Hospital

Bursa, Bursa, 16059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cholelithiasis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Selcan Akesen, Assoc. Prof. MD

CONTACT

00902242953274; selcanakesen@uludag.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group allocation. The erector spinae plane block will be performed by an anesthesiologist who will not participate in postoperative data collection or outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Model Details: Participants will be randomly assigned to two parallel groups. The intervention group will receive bilateral ultrasound-guided erector spinae plane block in addition to standard general anesthesia, while the control group will receive standard general anesthesia and postoperative analgesia without erector spinae plane block.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start (Estimated): May 24, 2026
• Primary Completion (Estimated): May 24, 2027
• Study Completion (Estimated): June 25, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)