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临床试验/NCT04650737
NCT04650737Unknown不适用

Single-Shot With Dexmedetomidine Versus Continuous Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control After Percutaneous Nephrolithotomy Prospective Randomized Clinical Trial

Cairo University0 个研究点目标入组 40 人开始时间: 2020年12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
入组人数
40
主要终点
Duration of postoperative Analgesia:

研究概览

简要总结

The current study is designed to assess the efficacy of a single shot ESPB with Dexmedetomidineversus continuous ESPB in perioperative analgesia for PCNL. Both techniques are conducted for patients undergoing PCNL under GA.

详细描述

Successful perioperative pain management is one of the main goals of the whole anesthetic practice. Kidney Surgeries, especially those involving the renal pelvis warrant special analgesic considerations. This is due to the sensitivity of the renal pelvis to pain. Its sub-diaphragmatic position affects deep breathing and coughing. Which renders adequate analgesia an important factor for maintaining good respiratory force and depth postoperative and reduces respiratory complications like atelectasis.

The Use of a single mode of analgesia in these settings , like the use of parenteral opioids for example, provides significantly less analgesic effect and more complications including respiratory depression , PONV (postoperative nausea and vomiting ) , constipation , urine retention ...etc.

The use of regional techniques as a part of multimodal pain management in these procedures provides superior analgesia and less complication rates.

This is added to high expectations of an easier perioperative course of PCNL (percutaneous nephrolithotomy) being and endoscopic procedure that does not involve a big skin incision. These expectations also include a short hospital stay. However PCNL is usually associated with significant pain and discomfort postoperatively. Various studies have been studying effects of integrating local and regional techniques in the perioperative pain management.

For Regional and local procedures of analgesia; Studies of Single Shot technique and catheter techniques has long been ongoing for many regional techniques for example like Pravertebral block and adductor canal block . These studies are conducted to determine the efficacy and adversities each technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients of age (18-50), ASA physical status I or II undergoing unilateral percutaneous nephrolithotomy

排除标准

  • - Body mass index greater than 35 kg/m
  • Pregnancy.
  • Unstable coronary artery disease, congestive heart failure, or arrhythmias.
  • Baseline heart rate (HR) less than 60 beats/min or baseline systolic blood pressure less than 100 mmHg.
  • Pre-existing neurological deficits or neuropathy.
  • Significant psychiatric or cognitive conditions interfering with consent or assessment.
  • Significant renal impairment (creatinine above 2 mg/dl)
  • Severe bronchopulmonary disease, including chronic obstructive pulmonary disease and obstructive sleep apnea.
  • Known contraindications to peripheral nerve block, including local skin infections, bleeding diathesis, and coagulopathy.
  • Allergies to local anesthetics, dexmedetomidine, or any component of multimodal analgesia.

研究组 & 干预措施

Group A (single shot,n=20)

Active Comparator

Patients in this group will receive 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine ;ultrasound guided ESPB

干预措施: single shot ESBP with dexmedtomidine (Drug)

Group B (continous infusion,n=20)

Active Comparator

Patients in this group will receive 30 ml bupivacaine 0.25%plus 1ml normal salinefollowed by continuous infusion of 8ml / hour of 0.125% bupivacaine for 24 hrs;ESPB

干预措施: continous ESPB (Drug)

结局指标

主要结局

Duration of postoperative Analgesia:

时间窗: post-operative period(24 hours)

"the time interval between extubation and the first request to postoperative analgesia

次要结局

  • Duration of sensory block(24 hours)
  • Visual analogue scale from 1 to 10,while 10 is the worst pain at rest and movement(24 hours)

研究者

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

Mina Adolf Helmy

Doctor

Cairo University

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