Evaluation of the Analgesic Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthesia in Quadratus Lumborum Block After Cesarean Delivery: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- total amount of morphine consumption
研究概览
简要总结
Postoperative pain is considered one of the major problems after abdominal operations, so proper pain control is one of the main issues in clinical practice. Cesarean section (CS.) is one of the most common abdominal surgeries and the use of CS. worldwide has increased to unprecedented levels. Effective postoperative analgesia enhances early recovery of the delivered mother, early ambulation, breast feeding and decreases the risk of postoperative thromboembolism. Therefore, Opioids are prescribed routinely for postoperative pain control, but they have many adverse effects such as nausea, vomiting, constipation, excessive sedation, dizziness, respiratory depression, and addiction, so it is important to practice alternative opioid sparing analgesic approaches. Recently, QL block is considered one of the perioperative pain management techniques used in patients undergoing various pelvi-abdominal surgeries. Quadratus Lumborum block inhibits both pain components (somatic and visceral) as a result of local anesthetic spread to the paravertebral spaceA study has been published comparing the analgesic efficacy between QLB and TAP block after cesarean section and proved that QL block II is more effective than TAP Block regarding pain relief and duration of action after CS. Also, Many studies have been published and prove that Combination of adjuvants like (fentanyl, clonidine and MgSo4,etc.) to local anesthetics agents helps in prolonging the analgesic effect and decrease 24hours opiate consumption.one of these adjuvants which used extensively in the regional techniques is dexmedetomidine, which is a selective alpha-2 adrenergic agonist. The optimal dosage of dexmedetomidine to be added to local anesthetics still remains unclear, but in other studies the dose of 0.5 μg/kg is widely used with no postoperative complications.
in this double blinded randomized controlled trial, the investigators compare the analgesic efficacy of adding dexmedetomidine to local anesthetic in quadratus lumborum block and their role in reduction postoperative opioid consumption after cesarean section
详细描述
Using a computer-generated randomization schedule, fifty patients will be randomly assigned into two equal groups: group A (bupivacaine only; n=25) and group B (bupivacaine plus dexmedetomidine; n=25).
All participants, investigators, care providers and outcome assessors will be blinded to the study group allocation.
The day Prior to surgery, all patients will have pre anesthesia check-up with routine and subjective investigations and explained about the Numerical Rating Scale (NRS) ranging from 0-10 (0 indicating no pain and 10 for severe intractable pain) The patients will be pre medicated by 40mg oral pantoprazole at night and in the morning of the surgery.
On arrival to the operating room, patients will be monitored by peripheral pulse oximetry, five-lead electrocardiogram and non-invasive blood pressure monitor. Two 18-gauge intravenous cannulae will be inserted in the nondominant arm and 1500 ml crystalloid will be infused as acoload plus ephedrine infusion 4mg/min. to prevent post spinal hypotension.
Random allocation of patients into one of two groups using concealed closed envelope method, the patients' envelope which contain the number of group will be opened and recorded in the data collection sheet as a number of group because the data collector will be blinded to the intervention on the patient, only the anesthetist knows each number is referring to which intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All participants, investigators, care providers and outcome assessors will be blinded to the study group allocation.
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for cesarean section under spinal anesthesia.
- •Normal uncomplicated pregnancies (ASA II).
- •BMI 18.5 to 34.9 kg/m2
排除标准
- •Patient refusal.
- •ASA III - IV patients.
- •Coagulation disorders.
- •Skin lesions or infection at site of proposed needle.
- •Known allergy to any of study drugs.
- •inability to comprehend or use the verbal rating pain scoring system
- •Difficulty in Ultrasonographic identification.
- •Opioid abuse.
- •BMI > 35 Kg/m2.
研究组 & 干预措施
group A (bupivacaine only)
Group A will be injected with 20 ml of 0. 25% bupivacaine in each side
干预措施: Bupivacaine 0.25% Injectable Solution (Drug)
group B (bupivacaine plus dexmedetomidine)
Group B will be injected with 20 ml of 0. 25% bupivacaine in each side added to it dexmedetomidine 0.5 μg/kg; (Precedex 100 μg/ml (Hospira, inc, lake forest, USA).
干预措施: bupivacaine plus dexmedetomidine (Drug)
结局指标
主要结局
total amount of morphine consumption
时间窗: up to 24 hours
Measure the total amount of morphine consumption at predetermined time intervals (4, 8, 12, and 24) hrs. after surgery
次要结局
- Numerical Rating Scale(up to 24 hours)
研究者
Mohamed Sayed elaraby
assistant lecturer of anesthesia,icuand pain management
Cairo University