THE EFFECTS OF EXTERNAL OBLIQUE INTERCOSTAL PLAN BLOCK AND ERECTOR SPINA PLAN BLOCK ON POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY OPERATION
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity (VAS Score)
研究概览
简要总结
This randomized controlled clinical trial investigates the comparative efficacy of two novel regional anesthesia techniques - the Erector Spinae Plane Block (ESPB) and the External Oblique Intercostal Plane Block (EOPB) - for postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
A total of 90 patients aged 18-65 years, with ASA physical status I or II, were randomly assigned to one of three groups: ESPB, EOPB, or control. Blocks were performed under ultrasound guidance prior to surgical incision. Pain intensity was evaluated using the Visual Analog Scale (VAS), and rescue analgesic consumption was recorded over the first 24 hours postoperatively.
The study aims to determine whether ESPB or EOPB offers superior pain control and reduced opioid consumption, and to assess patient satisfaction and safety. The results will inform multimodal analgesia strategies for upper abdominal laparoscopic surgery.
详细描述
Laparoscopic cholecystectomy (LC) is one of the most commonly performed upper abdominal surgeries. Despite being minimally invasive, LC is frequently associated with significant postoperative pain originating from both visceral and somatic sources. Inadequate pain control may lead to delayed recovery, increased opioid consumption, and patient dissatisfaction.
Regional anesthesia techniques have become increasingly important components of multimodal analgesia protocols for abdominal surgeries. Two recently described fascial plane blocks - the Erector Spinae Plane Block (ESPB) and the External Oblique Intercostal Plane Block (EOPB) - have shown promising results in reducing postoperative pain in thoracic and abdominal procedures.
This prospective, randomized, controlled clinical trial was conducted to evaluate and compare the analgesic effectiveness of ESPB and EOPB in patients undergoing elective LC under general anesthesia. After obtaining ethical approval (Protocol No: 2024/17/840-938) and informed consent, 90 adult patients aged 18-65 years with ASA physical status I or II were enrolled.
Participants were randomized into three groups using a sealed envelope technique:
Group 1 (ESPB): Received bilateral ultrasound-guided ESPB at the T7-8 level using 20 mL of local anesthetic solution (10 mL 0.5% bupivacaine + 10 mL 2% lidocaine) preoperatively.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The local anesthetic to be used in the study was prepared by two researchers who were not involved in the anesthesia application and did not participate in the postoperative data collection process. Postoperative patient data were recorded with the random ID assigned to each patient, and the researchers who collected data during this process were not informed about the patient groups. In addition, the anesthesiologist who performed the simple randomization also performed the nerve block, but was not involved in the collection of postoperative data. The anesthesiologists responsible for the anesthesia management and data collection process were not informed about the group distribution, and thus the study was conducted in a double-blind manner.
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
- •Age 18-65 years
- •ASA physical status I-II
- •Undergoing elective laparoscopic cholecystectomy under general anesthesia
- •Provided informed written consent
- •BMI between 18.5 and 30 kg/m²
- •Able to follow study instructions
排除标准
- •Allergy to local anesthetics
- •Chronic opioid use or chronic pain
- •Coagulopathy or anticoagulant use
- •Severe organ dysfunction
- •Pregnancy or breastfeeding
- •Neurological or psychiatric disorders
- •Infection at injection site
- •Refusal to participate
研究组 & 干预措施
Erector Spinae Plane Block (ESPB)
Participants in this group received a bilateral ultrasound-guided erector spinae plane block (ESPB) at the T7-T8 vertebral level under general anesthesia prior to surgical incision.
Under sterile conditions and ultrasound guidance, 20 mL of local anesthetic solution (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected bilaterally into the erector spinae plane at the T7-T8 level before incision. The block was performed after induction of general anesthesia but before the start of laparoscopic cholecystectomy.
干预措施: ESPB Block (Procedure)
External Oblique Intercostal Plane Block (EOPB)
Participants in this group received an external oblique intercostal plane block (EOPB) under ultrasound guidance prior to surgical incision.
Under ultrasound guidance, 20 mL of local anesthetic mixture (10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine) was injected into the fascial plane between the external oblique and internal intercostal muscles at the level of the 6th rib. The procedure was done after anesthesia induction but prior to laparoscopic cholecystectomy.
干预措施: EOPB Block (Procedure)
Control Group
Participants in this group did not receive any regional block. Postoperative analgesia was provided via standard systemic medications as needed.
No regional anesthesia technique was applied. Postoperative pain was managed using systemic rescue analgesia: 50 mg dexketoprofen trometamol IV when VAS ≥4, followed by 50 mg tramadol IV if pain persisted.
干预措施: Standard Systemic Analgesia (Drug)
结局指标
主要结局
Postoperative Pain Intensity (VAS Score)
时间窗: 0-24 hours postoperatively (measured at 15 min, 2, 4, 8, 12, 16, and 24 hours)
Postoperative pain will be measured using the Visual Analog Scale (VAS), where patients rate their pain on a 0-10 scale (0 = no pain, 10 = worst imaginable pain).
Total Rescue Analgesic Consumption (Dexketoprofen + Tramadol)
时间窗: 0-24 hours postoperatively
Total cumulative dose of rescue analgesics administered within the first 24 hours postoperatively will be recorded. Dexketoprofen (mg) and tramadol (mg) will be summed for each participant.
次要结局
- Time to First Rescue Analgesic Requirement(0-24 hours postoperatively)
- Patient Satisfaction Score(At 24 hours postoperatively)
- Incidence of Block-Related Complications(Intraoperative and within 24 hours postoperative)
- Intraoperative Opioid Requirement(Intraoperative period (during surgery))
研究者
Aykut Aydin
M.D.
SBU KARTAL DR.LUTFI KIRDAR SEHIR HASTANESI