Impact of Adding Dexmedetomidine as an Adjuvant to The Local Anesthetic in QL3 in Patient Undergoing Caesarean Section
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary outcome measured was the postoperative pain level score. The Visual Analog Scale (VAS) was used for assessment, where 0 represented no pain and 10 represented the worst pain.
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of adding Dexmedetomidine to local anesthetic agent (bupivacaine) for quadratus lumborum block (QLB) after spinal anesthesia in patient undergoing elective caesarean section. The main questions it aims to answer are:
- does adding dexmedetomidine enhance analgesia time?
- does adding dexmedetomidine reduce recovery time?
- does adding dexmedetomidine lower the need of analgesic medication after surgery? Study include 80 female pregnant non-obese patients scheduled for elective caesarean section.
详细描述
Effective postoperative analgesia facilitates a mother's quick recovery, enhances early ambulation, promotes breastfeeding, and reduces the risk of postoperative thromboembolism. The aim of this study was to evaluate the postoperative analgesic efficacy of combining a local anesthetic with dexmedetomidine (DEX) in a quadratus lumborum block (QLB) following a cesarean section (CS). A prospective, randomized, blind, controlled trial included 80 female patients aged 18 - 40 years old who underwent cesarean delivery under spinal anesthesia, were randomly assigned to two equal groups. Group dB received a quadratus lumborum block (QLB) with 20 ml of 0.25% bupivacaine and dexmedetomidine (0.5 μg/kg) on each side, while Group B received QLB with 20 ml of 0.25% bupivacaine alone on each side. The primary outcome measured was total analgesic consumption over 24 hours postoperatively. Secondary outcomes included Visual Analog Scale (VAS) scores, time to first analgesic request, and the incidence of side effects such as sedation, nausea, vomiting, shivering, pruritus, bradycardia, hypotension, and respiratory depression.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age over 18 years' old and less 40 years.
- •With body mass indices (BMI) between 18.5 and 34.9 kg/m²
- •Pregnancy more than 37 weeks with single fetus.
- •Intact membranes.
- •Women with a singleton pregnancy.
排除标准
- •ASA class III or higher,
- •contraindications to spinal anesthesia,
- •mental or neurological disorders,
- •chronic heart, renal, or liver diseases,
- •emergency surgery,
- •a history of blood coagulation disorders,
- •allergies or contraindications to the study drugs,
研究组 & 干预措施
Group dB
Adding Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The primary outcome measured was the postoperative pain level score. The Visual Analog Scale (VAS) was used for assessment, where 0 represented no pain and 10 represented the worst pain.
时间窗: The first 24 hours postoperatively
次要结局
- The time to the first analgesic request (within the first 24 hours postoperatively )(over the first 24 hours postoperatively)
- The total analgesic consumption(Over the first 24 hours postoperatively)
- Sedation levels(At 2, 4, 6, 12, and 24 hours postoperatively)
- Postoperative nausea and vomiting (PONV)(Within the first 24 hours)
- Mean Blood Pressure (MBP)(Perioperative period at intervals of 0, 5, 10, 20, and 30 minutes)
- Heart Rate (HR)(Perioperative period at intervals of 0, 5, 10, 20, and 30 minutes)
研究者
Majid Fakhir Mutar Alhamaaidah
Head of Scientific committee, Dep. of Anesthesiology, Principal Investigator
Al-Ayen Iraqi University