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临床试验/NCT05446727
NCT05446727已完成不适用

Quadratus Lumborum Block Versus Erector Spinal Block - Comparison of the Effectiveness of the Analgesic Effect in Patients After Abdominal Surgery

Jagiellonian University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Total long acting opioid consumption in oxycodone equivalents

研究概览

简要总结

Prior to surgery, patients will be stratified into groups according to the type of surgical procedure. The anticipated groups are as follows:

Patients with colorectal cancer

Patients with prostate cancer

Patients with renal cancer

Patients undergoing surgery for gallbladder cholelithiasis. The Erector Spinal Block (ESP) is based on the deposition of the local anesthetic in the inter-fascial space between the dorsal extensor muscle and the intercostal muscles at the height of the transverse processes. The scope of the blockade covers the dorsal and ventral branches of the thoracic spinal nerves, but also in most cases the investigetors are able to obtain a wide distribution of the drug into the paravertebral space by "permeating" the local anesthetic through the fascial compartments. The clinical effect of the blockade is due to blocking the nerve structures of the paravertebral space (spinal nerve branches and the sympathetic trunk). The scope of the blockade, after its execution at the level of Th5, most often includes the segments from Th1 to L1.

Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the anterior QL block ( QL1 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1.

详细描述

In abdomen surgery, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain), visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after labdomen surgery may predict development of chronic pain. Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.

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
Single (Investigator)

盲法说明

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients requiring abdomen surgery
  • Patients of age 18 and over
  • BMI < 40
  • Patients who are expected to stay in-hospital overnight after surgery

排除标准

  • Patient refusal
  • Contraindications to paravertebral blocks: Infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, and tumor occupying the thoracic paravertebral space, coagulopathy, bleeding disorder or therapeutic anticoagulation
  • Known allergy to local anesthetics
  • Inability to provide informed consent
  • Inability to use a PCA due to languate or comprehension barriers
  • BMI >= 40
  • Any patient on opioids for greater than or equal to 3 months duration prior to surgery
  • Patients with chronic pain syndromes

研究组 & 干预措施

Quadratus Lumborum block group

Experimental

Experimental: Quadratus Lumborum block group Patients were placed in the lateral decubitus position. After skin disinfection, a linear high-frequency ultrasound probe guarded with a sterile cover was set above the iliac crest and shifted cranially until the three abdominal wall muscles were distinguished. Then, it was moved medially until latissimus dorsi and quadratus lumborum (QLM) muscles were shown within identical short-axis views. A 21-gauge needle was inserted from the edge of the probe using an in-plane technique and advanced into the fascia over the QLM. After ensuring negative aspiration for blood, 30 ml of 0.35% ropivacaine bilateral was injected slowly into the fascial interspace.

干预措施: Ropivacaine injection (Drug)

erector spinae planae block

Experimental

The ESP block was performed with the patient in a sitting position. After skin disinfection, a linear high-frequency (L14-6NS) ultrasound probe, covered with a sterile sheath, was positioned sagittally 1-2 cm lateral to the midline at the level of the ninth thoracic vertebra (T9). The T9 level was earlier identified by palpating the spinous process of the seventh cervical vertebra and counting down nine intervertebral spaces. After identifying the erector spinae muscle (ESM) and transverse process, a 21-gauge needle was inserted deep into the ESM in a cranio-caudal direction, using an in-plane technique. The needle was advanced, ensuring that it crossed all muscle layers until it contacted the transverse process. A total of 60 mL of 0.35% ropivacaine was given. This procedure was performed bilaterally on each patient.

干预措施: Ropivacaine injection (Drug)

结局指标

主要结局

Total long acting opioid consumption in oxycodone equivalents

时间窗: 1 days

the total dosage of given drug

次要结局

  • Pain scores will be recorded at intervals. The Numerical Rating Scale (NRS) is an 11-point scale where 0 is no pain and 10 is the worst pain imaginable.(1 days)
  • Incidence of postoperative nausea-vomiting; itching; local anesthetic toxicity;(1vdays)

研究者

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

Tomasz Skladzien

Principal Investigator

Jagiellonian University

研究点 (1)

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