The Analgesic Efficacy of EXORA Block Versus Erector Spinae Plane Block in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Total opioid consumption
研究概览
简要总结
Laparoscopic cholecystectomy is still considered the gold standard for the surgical management of gallbladder disease due to its minimally invasive nature, shorter recovery time, and reduced postoperative complications. Despite these advantages, patients frequently experience moderate to severe postoperative pain, particularly in the early postoperative period, which can impede recovery, delay mobilization, and increase opioid consumption. Excessive opioid use after laparoscopic cholecystectomy is associated with several drawbacks, including nausea, vomiting, sedation, and delayed recovery. It also increases the risk of respiratory depression, especially in vulnerable patients, and may contribute to long-term opioid dependence. These risks highlight the importance of opioid-sparing strategies such as regional anesthesia techniques to improve patient outcomes and enhance recovery. Regional anesthesia techniques have emerged as essential components of multimodal analgesia strategies in abdominal surgeries. Among them, the Erector Spinae Plane (ESP) Block has gained popularity due to its relative ease of administration and favorable safety profile.
Recently, a novel fascial plane block known as the EXORA block has been introduced as a promising alternative for abdominal wall analgesia. This block, which targets a different anatomical plane, is postulated to provide comparable or superior analgesic efficacy to traditional methods while maintaining safety and simplicity in execution. Given the ongoing pursuit of optimal analgesia with minimal side effects, it is essential to compare emerging techniques, such as the EXORA block, with established methods like the ESP block.
The authors hypothesize that the EXORA and the ESP blocks provide superior postoperative analgesia compared to controls in patients undergoing laparoscopic cholecystectomy and that the EXORA block analgesic profile is superior to that of the ESP block.
详细描述
Following the tenets of the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT) 2025-updated statement, this prospective, randomized, double-blinded, controlled clinical trial will be conducted at Fayoum University Hospital (FUH) starting from October 2025 until the sample size is reached.
After obtaining approval from the local institutional ethics committee at Fayoum University Hospital (FUH) and registering the trial on ClinicalTrials.gov, all patients scheduled for elective cholecystectomy at FUH will sign a detailed informed consent form after fulfilling the eligibility criteria.
Patients will be randomly assigned to three equal groups with an allocation ratio of 1:1:1 (n=35) using computer-generated random numbers that will be sealed in a closed opaque envelope, opened by the anesthesiologist responsible for administering the ultrasound-guided block preoperatively
- Group A (EXORA Block Group): Patients will receive bilateral EXORA blocks.
- Group B (ESP Block Group): Patients will receive bilateral ESP blocks.
- Group C (Control Group): patients will not receive any block, only standard care.
Preoperatively, all patients will be assessed and investigated by complete blood count, Prothrombin time and concentration, kidney and liver functions. Additional investigations, such as serum electrolytes, ECG, ECHO, etc., will be ordered upon individual patient assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective laparoscopic cholecystectomy
- •ASA physical status I-III
排除标准
- •Known allergy to local anesthetics
- •Chronic pain or regular opioid use
- •Coagulopathy or anticoagulant therapy
- •Local infection at the block site
- •BMI more than 35 kg/m2
- •Neurological or psychiatric disorders
- •Refusal to participate
研究组 & 干预措施
control group
Group C (Control Group): patients will not receive any block, only standard care.
ESP block group
Group B (ESP Block Group): Patients will receive bilateral ESP blocks.
干预措施: Erector Spinae Plane block (Procedure)
EXORA block group
Group A (EXORA Block Group): Patients will receive bilateral EXORA blocks.
干预措施: EXORA block (Procedure)
结局指标
主要结局
Total opioid consumption
时间窗: Up to 24 hours after surgery
Post operative nalbuphine used in the first 24 hours in milligrams
次要结局
- Intraoperative Fentanyl consumption(From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours)
- Blood pressure(Upon arrival to Operating Room until 24 hours postoperative)
- Postoperative pain scores by Visual Analogue Scale (VAS)(From patient discharge to postoperative anesthesia care unit 24 hours postoperatively)
- Rescue analgesia(Upon recovery from General anesthesia up to 24 h postoperatively)
- Time needed to complete the block(From start of block procedure up to 1 hour)
- Sensory block distribution level (pin-prick test)(after 30 minuets from the block maneuver bilaterally)
- Heart rate(Upon arrival to Operating Room until 24 hours postoperative)
- Incidence of opioid-related side effects(From induction of anesthesia up to 24 h postoperatively)
- Incidence of Block-related side effects(From the time just after giving the block up to 24 h postoperatively)
- Intraoperative Fentanyl consumption(From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours)
- Time needed to complete the block(From start of block procedure up to 1 hour)
- Sensory block distribution level (pin-prick test)(after 30 minuets from the block maneuver bilaterally)
- Heart rate(Upon arrival to Operating Room until 24 hours postoperative)
- Blood pressure(Upon arrival to Operating Room until 24 hours postoperative)
- Rescue analgesia(Upon recovery from General anesthesia up to 24 h postoperatively)
- Incidence of opioid-related side effects(From induction of anesthesia up to 24 h postoperatively)
- Incidence of Block-related side effects(From the time just after giving the block up to 24 h postoperatively)
研究者
Mohamed Ahmed Hamed
Professor of Anesthesiology
Fayoum University Hospital