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临床试验/NCT04367233
NCT04367233尚未招募不适用

Quadratus Lumborum Block Versus Transversus Abdominis Block . Randomized Clinical Trial.

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
75
试验地点
2
主要终点
Morphine consumption

研究概览

简要总结

The advent of laparotomy replacement by minimally invasive techniques brought the obvious benefit of postoperative pain reduction. The application of transversus abdominis block has already demonstrated to reduce postoperative pain in laparoscopic hysterectomy. The comparison between it and quadratus lumborum block in cesarean sections showed that the latter was superior in relation to postoperative analgesia. The aim of this trial is to compare postoperative analgesia in patients receiving one or the other of these regional anesthesia techniques to prevent postoperative pain in gynecological laparoscopic surgeries. The recruited sample will be randomly distributed in three groups to receive placebo, transverse abdominal plan block or quadratus lumborum block, in a covert way for the patients and team. The primary outcome evaluated will be the postoperative consumption of opioid and the secondary outcome will be the evaluation of postoperative pain scores.

详细描述

: the sample will be divided into three groups and all participants will receive general anesthesia. Patients in the placebo group (PG) will be referred to the post-anesthesia recovery room after extubation and adequate hemodynamic and respiratory recovery. Patients in the tap block group (TBG) will receive 0.2 ml of 0.25% ropivacaine between the transverse and oblique internal muscles guided by ultrasound (US), on one side and after the other (the same dose), after the end of surgery. Patients in the quadratus lumborum group (LQG) will receive 0.2 ml/kg of 0.25% ropivacaine inside the middle layer of the thoracolumbar fascia guided by US, on one side and after the other (the same dose), after the end of the surgery. In all participants, the monitoring will include cardioscope, oximetry, non-invasive blood pressure and monitor of hypnoses level. After peripheral venous puncture, antibiotic prophylaxis with 2g cefazolin, and pre-anesthetic medication with midazolam 0.05 mg/kg. After 5 min pre-oxygenation, the patients will receive venous anesthetic induction with 2% lidocaine 1mg/kg without vasoconstrictor; fentanyl 4 µ/kg; propofol 2 mg/kg, or even adequate hypnosis guided by proper monitor; cisatracurium 0.15mg/kg, with tracheal intubation and mechanical ventilation after anesthetic plan confirmed with proper monitor and adequate muscle relaxation. Anesthesia will be maintained with propofol in continuous infusion guided by hypnoses monitor and remifentanil in continuous infusion between 0.1 and 0.5 µg/kg/min, according to patient need. All study participants will receive ondansetron 8 mg, dipyrone 2 g, ketoprofen 100 mg, dexamethasone 10 mg and morphine 3 mg. At the end of the surgery, after partial recovery from neuromuscular blockade, patients will receive atropine 0.01 mg/kg and neostigmine: 0.02mg/kg before tracheal extubation.

研究设计

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

盲法说明

A professional who will not participate in other stages of the study will conduct the drawing and envelopes preparation.

Masking: at the end of the surgery, the anesthesiologist will perform the blocking corresponding to the patient's group and will not participate in other stages of the study. A professional who does not know the group to which each patient belongs will perform the collection and analysis of the endpoint variables.

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled to gynecological video laparoscopy.

排除标准

  • Allergy to any component of the study protocol, coagulopathies.

结局指标

主要结局

Morphine consumption

时间窗: 12 hours

Consumption of morphine in the postoperative period,during hospital stay

Codeine consumption

时间窗: Two days

Consumption of codeine during the 48 hours following the surgery

次要结局

  • Postoperative pain(Two days)

研究者

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

Joaquim Edson Vieira

Associate professor

University of Sao Paulo General Hospital

研究点 (2)

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