Comparison of the Effects of Recto-Intercostal Plane Block and External Oblique Intercostal Plane Block on Postoperative Analgesia in Patients Undergoing Elective Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Cumulative Postoperative Tramadol Consumption
研究概览
简要总结
This prospective observational study aims to compare the effects of bilateral ultrasound-guided recto-intercostal plane block(RIPB) and bilateral ultrasound-guided external oblique intercostal plane block(EOIPB) on postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
Both blocks are performed after anesthesia induction as part of routine preemptive multimodal analgesia practice. Patients who receive bilateral recto-intercostal plane block will be included in the RIPB group, and patients who receive bilateral external oblique intercostal plane block will be included in the EOIPB group.
The primary outcome is cumulative intravenous tramadol consumption via patient-controlled analgesia during the first 24 postoperative hours. Secondary outcomes include postoperative pain scores at rest and during activity, rescue analgesic requirement, postoperative nausea and vomiting, time to mobilization, length of hospital stay, quality of recovery assessed using the Quality of Recovery-15 questionnaire, and block-related complications.
详细描述
Laparoscopic cholecystectomy is one of the most commonly performed minimally invasive abdominal surgical procedures. Although it is associated with less postoperative pain and faster recovery compared with open surgery, postoperative pain may still occur due to trocar insertion, abdominal wall trauma, pneumoperitoneum-related peritoneal irritation, and visceral manipulation. Inadequate analgesia may delay mobilization, increase analgesic consumption, contribute to postoperative nausea and vomiting, and negatively affect postoperative recovery.
Ultrasound-guided fascial plane blocks are increasingly used as part of multimodal analgesia strategies for abdominal surgery. These techniques may reduce postoperative analgesic requirements by targeting the thoracoabdominal nerve branches that supply the abdominal wall. The recto-intercostal plane block and the external oblique intercostal plane block are two ultrasound-guided fascial plane blocks that may provide analgesia for the upper abdominal wall through different anatomical planes.
This study is designed as a prospective observational study in patients scheduled for elective laparoscopic cholecystectomy under general anesthesia. Patients will be included according to the regional analgesia technique performed as part of routine clinical practice. Patients receiving bilateral recto-intercostal plane block will form the RIPB group, while patients receiving bilateral external oblique intercostal plane block will form the EOIPB group. Both blocks will be performed after anesthesia induction as part of a preemptive analgesia approach.
All patients will receive standardized general anesthesia and routine postoperative multimodal analgesia. Intravenous tramadol will be administered postoperatively using a patient-controlled analgesia device. Postoperative pain intensity will be evaluated using the Numeric Rating Scale at predetermined time points during the first 24 hours. Total tramadol consumption, rescue analgesic requirement, postoperative nausea and vomiting, quality of recovery, mobilization time, length of hospital stay, and possible block-related complications will be recorded.
The study aims to determine whether recto-intercostal plane block provides superior postoperative analgesia compared with external oblique intercostal plane block in patients undergoing elective laparoscopic cholecystectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •Age between 18 and 75 years
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- •Written informed consent obtained
排除标准
- •Refusal to participate
- •Inability to understand the study protocol or provide informed consent
- •Known allergy to local anesthetics, tramadol, paracetamol, dexketoprofen, or other study drugs
- •Chronic opioid or steroid use
- •Psychiatric or cognitive disorder preventing reliable pain assessment
- •Inability to use patient-controlled analgesia
- •Pregnancy or breastfeeding
- •Coagulopathy
- •Infection at the block site
- •Difficult or prolonged intubation requiring three or more attempts
- •Conversion to open surgery
- •Surgery lasting longer than 120 minutes
- •Intraoperative or postoperative complications requiring deviation from the standard analgesia protocol
研究组 & 干预措施
RIPB Group
Patients who received bilateral ultrasound-guided recto-intercostal plane block after anesthesia induction as part of routine preemptive analgesia for elective laparoscopic cholecystectomy.
干预措施: Bilateral Ultrasound-Guided Recto-Intercostal Plane Block (Procedure)
EOIPB Group
Patients who received bilateral ultrasound-guided external oblique intercostal plane block after anesthesia induction as part of routine preemptive analgesia for elective laparoscopic cholecystectomy.
干预措施: Bilateral Ultrasound-Guided External Oblique Intercostal Plane Block (Procedure)
结局指标
主要结局
Cumulative Postoperative Tramadol Consumption
时间窗: Postoperative 24 hours
Total intravenous tramadol consumption delivered via patient-controlled analgesia during the first 24 hours after surgery.
次要结局
- Postoperative Pain Scores at Rest(Postoperative 1, 3, 6, 9,12, 18, and 24 hours)
- Postoperative Pain Scores During Activity(Postoperative 1, 3, 6, 9, 12, 18, and 24 hours)
- Intraoperative remifentanil consumption(From induction of anesthesia to the end of surgery)
- Quality of Recovery(Postoperative 24 hours)
- Rescue Analgesic Requirement(Postoperative 24 hours)
- Postoperative Nausea and Vomiting(Postoperative 24 hours)
- Length of Hospital Stay(From the date of surgery through the date of hospital discharge, assessed up to 30 days postoperatively.)
- Block-Related Complications(Postoperative 24 hours)