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临床试验/NCT05664542
NCT05664542招募中4 期

Efficacy of Erector Spinae Block With Ropivacaine and Dexmedetomidine on Opioid Consumption After Lumar Spine Surgeries - A Randomised Controlled Trial

Security Forces Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年12月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
42
试验地点
1
主要终点
24 hours opioid consumption

研究概览

简要总结

The aim of this study is to investigate the role of 0.5 micrograms/kg of dexmedetomidine with 0.2 % ropivacaine in erector spinae block in reducing opioid consumption for patients undergoing lumbar spine surgeries. This study will help in understanding the role of adding dexmdetomidine to ropivacaine in erector spinae block in reducing opioid consumption after lumbar spine surgeries

详细描述

A number of adjuvants have been used with local anesthetics including dexamethasone, nalbuphine and dexmedetomidine etc with the aim of improving quality and duration of peripheral nerve blocks. Dexmedetomidine is a potent alpha-2 agonist which can prolong the duration of regional anesthesia block when used in combination with local anesthetics. Although, there is no consensus on the dose of dexmedetomidine for peripheral nerve block considering the fact that it can lower heart rate and blood pressure intraoperatively. Investigators therefore, planned this randomised controlled trial to investigate the role of 0.5 micrograms/kg of dexmedetomidine with 0.2 % ropivacaine in erector spinae block for patients undergoing lumbar spine surgeries.

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

Procedure will be done after patient will undergo GA for surgery. Medications will be prepared by anesthetist not involved in the study. The nurse/doctor who will assess the outcome will not know the group allocation

入排标准

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

入选标准

  • Patients aged between 18 and 70 years, scheduled to undergo lumbar spine surgeries with an ASA score of 1 to 3 will be included in the study

排除标准

  • Patients who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with either contraindications for regional anesthesia, known allergy to local anesthetics or dexmedetomidine, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate patient controlled analgesia (PCA) system, psychiatric disorders or use of psychiatric medications will not be included in the study.

研究组 & 干预措施

ESPB group

Experimental

this group will receive ESPB using ropivacaine and dexmedetomidine

干预措施: ESPB (regional Block) (Other)

ESPB group

Experimental

this group will receive ESPB using ropivacaine and dexmedetomidine

干预措施: ropivacaine and dexmedetomidine (Drug)

结局指标

主要结局

24 hours opioid consumption

时间窗: 24 hours

opioid consumption in mg during first 4 hours postoperatively

次要结局

  • Occurrence of postoperative nausea and vomiting (PONV)(24 hours)
  • pain score(24 hours)
  • Occurrence of drowsiness(24 hours)

研究者

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

Anwar ul Huda

Principal investigator

Security Forces Hospital

研究点 (1)

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