External Oblique Intercostal Block Versus Port-Site Infiltration for Postoperative Analgesia in Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cumulative opioid consumption in the first 24 hours after surgery
研究概览
简要总结
Adequate postoperative pain management is essential for improving patient comfort and recovery after laparoscopic cholecystectomy. This study evaluated the effectiveness of the external oblique intercostal block compared with port-site infiltration in terms of pain scores and opioid consumption during the first 24 hours after surgery.
详细描述
Adequate pain relief in the postoperative period is a crucial determinant of patient comfort, early mobilization, and overall recovery after laparoscopic cholecystectomy. Effective analgesia not only improves patient satisfaction but also reduces postoperative complications, facilitates respiratory function, and shortens hospital stay. Conversely, insufficient pain control may lead to undesirable outcomes such as delayed mobilization, nausea, vomiting, increased opioid requirements, and prolonged recovery.
Regional anesthesia techniques, particularly abdominal wall and fascial plane blocks, have gained increasing attention as part of multimodal analgesia strategies aimed at reducing opioid consumption and minimizing related adverse effects. Among these, the external oblique intercostal block (EOIB) has recently been described as a novel regional technique that may provide effective postoperative pain relief.
In clinical practice, port-site infiltration with local anesthetics is a commonly used and simple technique for providing postoperative analgesia in laparoscopic procedures, although its effectiveness may be limited.
The present study was designed to compare the effectiveness of the external oblique intercostal block with port-site infiltration in patients undergoing laparoscopic cholecystectomy, with a focus on postoperative pain scores and opioid consumption during the first 24 hours after surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio. A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist administering the block/blocks about which group the patient is in immediately before administration. Researchers, surgeons, and nurses will not be aware of the randomization of groups.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-75 undergoing elective Laparoscopic Cholecystectomy
- •American Society of Anesthesiologists (ASA)classification I-III patients.
- •Patients who can use PCA.
- •Patients who will sign the informed consent form.
排除标准
- •They will refuse to participate.
- •They will have a body mass index (BMI) greater than 35 kg/m
- •They will have contraindications to peripheral nerve blocks (e.g., coagulopathy, abnormal INR, thrombocytopenia, local or systemic infection).
- •They will have clinically significant cardiovascular or cerebrovascular disease.
- •They will have severe hepatic, renal, or respiratory dysfunction. They will have known drug allergies.
- •They will have a history of substance abuse.
- •They will have chronic opioid use, defined as regular use of ≥15 mg oral morphine equivalent per day for at least 30 consecutive days within the past 3 months.
- •They will have chronic pain syndromes (e.g., fibromyalgia, diabetic neuropathy, or chronic low back pain).
- •They will have neuropsychiatric disorders or cognitive impairment that precludes effective communication with the investigators.
研究组 & 干预措施
Group EOIB
A bilateral External Oblique Intercostal Block (30 ml, %0.25 bupivacaine, bilaterally) + IV morphine patient-controlled analgesia (PCA)
干预措施: External Oblique Intercostal Block (Procedure)
Group EOIB
A bilateral External Oblique Intercostal Block (30 ml, %0.25 bupivacaine, bilaterally) + IV morphine patient-controlled analgesia (PCA)
干预措施: ıv morphine PCA (Drug)
Group PSI
Port sites injection (5 mL at each port site, 0.25% bupivacaine solution ) + IV morphine patient-controlled analgesia (PCA)
干预措施: Port-Site Infiltration (Procedure)
Group PSI
Port sites injection (5 mL at each port site, 0.25% bupivacaine solution ) + IV morphine patient-controlled analgesia (PCA)
干预措施: ıv morphine PCA (Drug)
结局指标
主要结局
Cumulative opioid consumption in the first 24 hours after surgery
时间窗: Postoperative day 1
The primary outcome will be defined as cumulative opioid consumption during the first 24 hours following surgery, which will be calculated in intravenous morphine milligram equivalents (IV-MME), encompassing both PCA- administered morphine and rescue intravenous tramadol, according to the standardized ESAIC conversion guidelines. Patients can request opioids via a PCA device when their NRS score is≥ 4.
次要结局
- The number of patients who required rescue analgesia.(Postoperative day 1)
- Numerical Rating Scale Assessment of Postoperative Pain(Postoperative day 1)
- Cumulative opioid consumption in the first 12 hours after surgery(Postoperative 12 hours)
- Time to First Opioid Demand via PCA(Postoperative day 1)
- Intraoperative Remifentanil Consumption(The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes)
- The patient number of Rescue antiemetic Requirement(Postoperative day 1)
- The number of patients with complications(Postoperative 7 days on an average)
- Cumulative opioid consumption in the first 12 hours after surgery(Postoperative 12 hours)
- Intraoperative Remifentanil Consumption(The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes)
- The patient number of Rescue antiemetic Requirement(Postoperative day 1)
- Numerical Rating Scale Assessment of Postoperative Pain(Postoperative day 1)
- Time to First Opioid Demand via PCA(Postoperative day 1)
- The number of patients who required rescue analgesia.(Postoperative day 1)
- The number of patients with complications(Postoperative 7 days on an average)
研究者
Esra Turunc
Director
Ondokuz Mayıs University