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RIPB Versus EOIPB for Pain Control After Laparoscopic Cholecystectomy (RIPB-EOIPB)

Comparison of the Effects of Recto-Intercostal Plane Block and External Oblique Intercostal Plane Block on Postoperative Analgesia in Patients Undergoing Elective Laparoscopic Cholecystectomy

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (实际的)

170

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Istanbul
      • Sancaktepe、Istanbul、土耳其(türkiye)、34000
        • Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

Adult patients aged 18-75 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for elective laparoscopic cholecystectomy under general anesthesia and who provide written informed consent will be included.

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.
Bilateral recto-intercostal plane block was performed under ultrasound guidance after anesthesia induction. Local anesthetic was injected into the fascial plane between the rectus abdominis muscle and the intercostal structures as part of routine preemptive analgesia.
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.
Bilateral external oblique intercostal plane block was performed under ultrasound guidance after anesthesia induction. Local anesthetic was injected into the fascial plane between the external oblique muscle and the intercostal muscles as part of routine preemptive analgesia.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cumulative Postoperative Tramadol Consumption
大体时间:Postoperative 24 hours
Total intravenous tramadol consumption delivered via patient-controlled analgesia during the first 24 hours after surgery.
Postoperative 24 hours

次要结果测量

结果测量
措施说明
大体时间
Postoperative Pain Scores at Rest
大体时间:Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours
Pain intensity at rest assessed using the Numeric Rating Scale, ranging from 0 indicating no pain to 10 indicating the worst imaginable pain.
Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours
Postoperative Pain Scores During Activity
大体时间:Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours
Pain intensity during activity assessed using the Numeric Rating Scale, ranging from 0 indicating no pain to 10 indicating the worst imaginable pain.
Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours
Quality of Recovery
大体时间:Postoperative 24 hours
Quality of recovery assessed using the Quality of Recovery-15 questionnaire.Quality of recovery will be assessed using the Quality of Recovery-15 questionnaire. The Quality of Recovery-15 is a 15-item patient-reported outcome measure with a total score ranging from 0 to 150, where higher scores indicate better postoperative recovery.
Postoperative 24 hours
Rescue Analgesic Requirement
大体时间:Postoperative 24 hours
Number of patients requiring additional rescue analgesia due to Numeric Rating Scale score of 4 or higher.
Postoperative 24 hours
Postoperative Nausea and Vomiting
大体时间:Postoperative 24 hours
Incidence of postoperative nausea and vomiting during the first 24 hours after surgery.
Postoperative 24 hours
Time to Mobilization
大体时间:From the end of surgery until first postoperative mobilization, assessed up to 48 hours postoperatively.
Time from the end of surgery to first postoperative mobilization.
From the end of surgery until first postoperative mobilization, assessed up to 48 hours postoperatively.
Length of Hospital Stay
大体时间:From the date of surgery through the date of hospital discharge, assessed up to 30 days postoperatively.
Duration of postoperative hospital stay until discharge.
From the date of surgery through the date of hospital discharge, assessed up to 30 days postoperatively.
Block-Related Complications
大体时间:Postoperative 24 hours
Incidence of complications related to the regional block procedure, including pneumothorax and local anesthetic systemic toxicity.
Postoperative 24 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月15日

初级完成 (实际的)

2026年8月31日

研究完成 (实际的)

2026年8月31日

研究注册日期

首次提交

2026年5月15日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月26日

研究记录更新

最后更新发布 (实际的)

2026年9月2日

上次提交的符合 QC 标准的更新

2026年9月1日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared due to institutional data privacy policies and participant confidentiality.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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