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临床试验/NCT06768593
NCT06768593已完成不适用

Evaluation of the Effectiveness of Ultrasound-Guided Recto-Intercostal Fascial Plane (RIFP) Block in Postoperative Analgesia Management in Patients Undergoing Laparoscopic Cholecystectomy

Istanbul Medipol University Hospital2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2025年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
77
试验地点
2
主要终点
Rescue analgesic use

研究概览

简要总结

Ultrasound-guided Recto-Intercostal Fascial Plane (RIFP) Block is performed by injecting local anesthetic deep between the 7th rib and the costochondral aspect of the rectus muscle. It provides blockage of both the anterior and lateral cutaneous branches of T6-T10/11 and analgesia of the sternum, epigastrium, and upper abdomen (1).

Studies show that RIFP block is effective for postoperative analgesia, sternum revision, and cardiac surgery. However, its effect on patients undergoing laparoscopic cholecystectomies has not been studied yet. The investigators hypothesize that RIFP block performed in laparoscopic cholecystectomies would reduce postoperative rescue analgesic use and postoperative opioid consumption in the first 24 hours after surgery.

详细描述

Cholecystectomy is the most common abdominal surgical procedure performed in developed countries and is usually performed laparoscopically. Many factors play a role in the pain that develops after laparoscopic cholecystectomy and it has both somatic and visceral components. Phrenic nerve irritation as a result of CO₂ insufflation into the peritoneal cavity, abdominal distension, tissue trauma, trauma due to gallbladder removal, sociocultural differences, and individual factors are the factors that play a role in the emergence of this pain. Postoperative pain is an acute pain that is accompanied by an inflammatory process that occurs due to surgical trauma and gradually decreases with tissue healing. Pain in the postoperative period in patients undergoing laparoscopic cholecystectomy is a serious problem that reduces patient comfort and delays the patient's return to normal life after surgery. Effective postoperative pain management prevents many effects such as shallow breathing and delayed mobilization.

RIFPB performed with ultrasound (US) guidance is a new abdominal plane block. The rectus muscle attaches to the cartilage of the 7th rib in the epigastrium on the cranial side. Injecting local anesthetic between the 7th rib and the rectus muscle provides effective analgesia in the sternal, epigastric, and upper abdominal areas. It can be used as a complementary block for thorax, and a stand-alone technique for the abdomen. RIFPB provides analgesia at T6-T10/11 dermatome levels for lateral and medial cutaneous branches. Visualizing son anatomy with US is easy and the spread of local anesthetic can be easily detected. According to the literature, there are case series reporting RIFPB to be effective in cardiac surgery, and sternum revision surgery, both for postoperative analgesia management and as a sole anesthetic method alone. The investigators hypothesize that this block can provide effective postoperative analgesia in laparoscopic cholecystectomy operations due to its mechanism of action. This study aims to evaluate the effectiveness of USG-guided RIFB block for primary postoperative analgesia management after laparoscopic cholecystectomy 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
Double (Participant, Outcomes Assessor)

盲法说明

The outcomes assessor and participants will be blinded to the study.

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

入选标准

  • American Society of Anesthesiologists (ASA) classification I-II patients
  • Laparoscopic cholecystectomy operation under general anesthesia

排除标准

  • patients with
  • with a history of bleeding diathesis
  • v receiving anticoagulant treatment,
  • with allergies or sensitivity to drugs used,
  • with an infection on the puncture site
  • with a history of alcohol or drug addiction,
  • with congestive heart failure
  • with liver or kidney disease
  • who do not accept the procedure or participate in the study

结局指标

主要结局

Rescue analgesic use

时间窗: Need for rescue analgesics at 1, 3, 6, 12,18, and 24 hours postoperatively.

The primary aim is to investigate postoperative rescue analgesic use and postoperative opioid consumption.

次要结局

  • Compare postoperative pain scores (Numeric Rating Scale - NRS scores)(NRS scores at rest and while moving will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively.)
  • Side effects and complications(Side effects and complications will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Ince

Assist Prof

Istanbul Medipol University Hospital

研究点 (2)

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