Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Pain and Respiratory Function in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Forced Expiratory Volume in 1 Second (FEV1)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Erector Spinae Plane Block (Procedure)
Control Group
Patients undergoing elective laparoscopic cholecystectomy who will receive standard general anesthesia and postoperative analgesic management without erector spinae plane block.
结局指标
主要结局
Change in Forced Expiratory Volume in 1 Second (FEV1)
时间窗: 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.
Change in Forced Vital Capacity (FVC)
时间窗: 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.
次要结局
- 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)
研究者
Selcan Akesen
Associate Professor of Anesthesiology
Uludag University