Comparative Study Between the Analgesic Effect of Dexmedetomidine and Magnesium Sulfate As Adjuvant to Bupivacaine Using Ultrasound-Guided Transversus Abdominis Plane Block in Abdominal Hysterectomy : a Randomized Double-blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- the time of the first request of rescue analgesia
研究概览
简要总结
Over 80% of patients who undergo surgery suffer from acute postoperative pain, with 75% of them rating the pain severity as moderate, severe, or extreme. Studies have shown that less than 50% of patients who undergo surgery report adequate relief from postoperative pain.
Additionally, if pain is not promptly managed after surgery, it can hinder a patient's ability to walk, potentially causing adverse effects such as thromboembolism, myocardial ischemia, and arrhythmia.
The opioid analgesics are most commonly used as parenteral agents to manage post operative pain but the problem of respiratory depression remains to be considered.
This study is designed to compare the analgesic effect between dexmedetomidine versus magnesium sulfate as adjuvant to bupivacaine using ultrasound guided Transversus Abdominis Plane block in patients undergoing abdominal hysterectomy
详细描述
In addition to parenteral opioids and NSAIDS, various other methods used for post operative analgesia are infiltration of local anaesthetic agents, dermal patches, patient-controlled analgesia and epidural catheters, etc.
Numerous studies have demonstrated that when enhanced recovery procedures (ERPs) are used, hospital length of stay, time to return to normal function, postoperative ileus duration, thromboembolic complications, morbidity, and all of these factors are all reduced. In order to achieve the best pain treatment, many ERPs use a multimodal approach, decreasing the use of opioids as the primary analgesic in Favor of neuraxial and regional anaesthetic techniques.
One of the regional techniques routinely used is the transversus abdominis plane (TAP) block. Its widespread use in abdominal surgeries is due to its technical simplicity and trustworthy analgesia.
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
Patients will be randomly allocated into one of the two study designed groups using computer-generated random numbers table.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA classification I-ll,
- •Aged >18 years,
- •weight 50-85 kg,
- •Patients who will undergo total abdominal hysterectomy
排除标准
- •• ASA classification I-ll,
- •Aged >18 years,
- •weight 50-85 kg,
- •Patients who will undergo total abdominal hysterectomy
研究组 & 干预措施
group A
Patients will receive 18 ml 0.5% bupivacaine (Sunnypivacaine®) plus 0.5 µg/kg of dexmedetomidine (Precedex® 100 µg/ml) diluted in 2 ml of normal saline at each side
干预措施: bupivacaine 0.5% (Drug)
group A
Patients will receive 18 ml 0.5% bupivacaine (Sunnypivacaine®) plus 0.5 µg/kg of dexmedetomidine (Precedex® 100 µg/ml) diluted in 2 ml of normal saline at each side
干预措施: Dexmedetomidine (Drug)
group b
patients will receive 18 ml 0.5% bupivacaine (Sunnypivacaine®) plus 1.5 mL (150 mg) MgSO4 and 0.5 mL normal saline at each side
干预措施: bupivacaine 0.5% (Drug)
group b
patients will receive 18 ml 0.5% bupivacaine (Sunnypivacaine®) plus 1.5 mL (150 mg) MgSO4 and 0.5 mL normal saline at each side
干预措施: MgSO4 (Drug)
结局指标
主要结局
the time of the first request of rescue analgesia
时间窗: 24 hours
the time of the first request of rescue analgesia (calculated from the time of the TAP block application)
次要结局
未报告次要终点
研究者
Abdelrahman Mahfouz Ali
resident doctor at Anaesthesia, Intensive Care and Pain Management department Faculty of Medicine, Assiut University
Assiut University