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临床试验/NCT07745972
NCT07745972招募中不适用

Evaluation of the Effect of Ultrasound-Guided Bilateral Recto-Intercostal Fascial Plane Block on Postoperative Pain, Opioid Consumption, and Quality of Recovery in Laparoscopic Cholecystectomy Surgery: A Prospective, Randomized, Double-Blind Controlled Clinical Study

Istinye University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年8月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Postoperative opioid consumption

研究概览

简要总结

The aim of the study is to reduce postoperative pain by performing rectointercostal block in L/S cholecystectomy surgeries. Main goal is to provide well managed post-operative analgesia.

详细描述

The patients will be divided into two groups and general anesthesia will be applied to all of them. There will be no regional anesthetic technique to be performed, on the other hand, rectointercostal nerve block will be applied to patients in the other group before the patients are extubated. Study randomization is done with computer-generated randomization codes (computer-generated) by a physician who will not participate in patient follow-up. Interfascial plane block (rectointercostal block) will be given to the anesthesiologist in a sealed envelope by an independent assistant staff outside the study, the patient will not know which block is applied. The anesthetist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another anesthetist blinded to the study.

For the standardization, the block procedure will be performed by an experienced anesthesiologist who has performed at least 20 previous successful and uncomplicated procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI < 35 kg/m²
  • Patients with ASA scores I and II

排除标准

  • Patients who do not want to be included in the study
  • Psychiatric and neurological disease with blurred consciousness
  • Patients with ASA > 3
  • BMI > 35 kg/m²
  • Abnormality in coagulation parameters
  • History of allergy to local anesthetic drugs
  • Infection at the injection site

研究组 & 干预措施

Block

Experimental

Recto intercostal Plane Block Group

干预措施: Rectointercostal facial plane block using bupivacaine 0.25% (Procedure)

Control

No Intervention

Control Group

结局指标

主要结局

Postoperative opioid consumption

时间窗: 24 hours

Contramal consumption in the first 24 hours after surgery

次要结局

  • NRS Scores(At 1,3, 6, 12, 18, 24 hours)
  • Quality of recovery(24 hours)
  • Nausea and vomiting(At 1,3, 6, 12, 18, 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bora Bilal

Proffesor MD

Istinye University

研究点 (2)

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