Systemic Versus Local Dexamedetomedine As an Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block in Kidney Exploration Surgeries ,A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The duration of analgesia, this was defined as the time in minutes to the first request for postoperative analgesics.
研究概览
简要总结
The aim of this study is to investigate the analgesic effect of local versus systemic dexamedetomedine as adjuvant to bupivacaine in erector spinae block in kidney exploration surgeries.
详细描述
Open Kidney surgeries remain one of the approaches used for those patients are requiring partial or radical nephrectomy and is associated with a high incidence of intense immediate postoperative pain and chronic pain for months following surgery.
Effective treatment of postoperative pain allows early mobilization of the patient, shortens the recovery and discharge time, prevents the development of chronic pain, and increases satisfaction and long-term quality of life.
Current modalities used to manage pain for patients undergoing kidney exploration include oral and parenteral opioid administration, local anesthetic infiltration, and certain neuraxial and regional anesthesia procedures including thoracic epidurals and paravertebral blocks.
The erector spinae plane (ESP) block is a newer regional anesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. The technique is relatively easy to perform on patients, and it is performable with minimal or no sedation in the pre-operative holding area.
Ultrasound is a non-invasive visualization technology that helps capture the anatomical structure of target tissues; it can help guide the direction and depth of anesthesia puncture needles, thus reducing the risk of complications.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In our randomized controlled trial, we employed masking (also called blinding) to reduce bias. Participants were unaware of whether they were receiving the intervention or control. Caregivers were instructed not to reveal this information, and outcome assessors who evaluated results were kept separate from intervention delivery.
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
- 否
入选标准
- •. kidney exploration surgeries.
- •ASA I/II patients.
排除标准
- •Getting opioid analgesics prior to surgery.
- •Local infections at the site where needle for block is to be inserted.
- •ASAIII/IV.
- •Pregnancy.
- •History of drug addiction or alcohol abuse or a psychiatric illness,
研究组 & 干预措施
Group Ι Block only (group BO) (control group)
Ultrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9 %) +10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia
干预措施: Bupivacaine Hydrochloride (Drug)
Group ΙI (group DL):
Ultrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% plus dexmedetomidine (0.5µg/kg) diluted in 2ml normal saline Na cl 0,9%) + 10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
Group III (group D IV):
Ultrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9%) + dexmedetomidine (0.5µg/kg) diluted with 10 ml normal saline IV infusion by syringe pump over 10 min after 10 min from the induction of general anesthesia
干预措施: Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) (Drug)
结局指标
主要结局
The duration of analgesia, this was defined as the time in minutes to the first request for postoperative analgesics.
时间窗: at 60 , 180 minutes
The duration of analgesia, this was defined as the time in minutes to the first request for
次要结局
- 2. Total postoperative opioid consumption (Nalbuphine consumption (mg) within the 48-hour period .(at 1, 3, 6, 12, 24, 36 and 48 hours)
- Ramsay Sedation Scale (RSS) (1: anxious; 2: cooperative and tranquil; 3: responding to command; 4: brisk response to stimuli; 5: sluggish response to stimuli; and 6: no response to stimuli) will be all assessed(at 1, 3, 6, 12, 24, 36 and 48 hours)
- Minimum alveolar concentration (MAC) requirements(during intraoperative periods expressed in minutes)
- Intraoperative hemodynamic parameters blood pressure(at 1, 3, 6, hours)
研究者
Soudy Salah Hammad
Lecturer of anesthesia and surgical intensive care
Aswan University