Comparison Between Fentanyl And Midazolam As Additives To Bupivacaine In Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Abdominal Surgeries; A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Onset of the Analgesic effect of TAP block with different additives
研究概览
简要总结
Pain triggers a complex biochemical and physiological stress response leading to impairment of pulmonary, immunological and metabolic functions.
The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used for various surgeries through the lower to mid-abdominal wall.The addition of fentanyl to the local anaesthetic in ultrasound-guided TAP block prolongs the analgesia, lowers postoperative pain, and decreases the opioid consumption. Adding midazolam as a bupivacaine adjuvant for TAP block reduces the 24-h morphine consumption extends the postoperative analgesia duration. The aim of the work is to study the effect of the addition fentanyl and midazolam on the onset, duration of the analgesic effect of Tap block intraoperative fentanyl consumption, Time for first rescue Analgesia.
in patients undergoing simple unilateral abdominal surgeries.
详细描述
Informed written consent will be obtained from study participants or their legally authorized representative. This is a randomized controlled double blinded study; patients will be enrolled in the study and will be randomized and equally divided into three groups:
Group A: (TAP block with 20 ml of bupivacaine 0.25% and 50 μ g of fentanyl) Group B: (TAP block with 20 ml bupivacaine 0.25% and 50 μ g /kg midazolam) Group C: (TAP block with 20 ml bupivacaine 0.25% only). Induction of general anaesthesia will be performed using a regimen of IV 1 μ g/kg fentanyl and Propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of atracurium.
Maintenance of Anaesthesia:
Anaesthesia will be maintained with inhaled sevoflurane with MAC 2% in oxygen enriched air (FiO2=0.5) and top up doses of Atracurium (0.1 mg/kg) IV will be administered every 30 minutes.
Ringer acetate will be infused to replace their fluid deficit, maintenance and losses, and the patients will be mechanically ventilated using the appropriate setting that will keep the end-tidal CO2 at 30-35mmHg.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physical status ASA I and ASA ll.
- •Age ≥ 18 and ≤ 65 Years.
- •Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m
- •Patients undergoing Abdominal Surgeries.
- •Patient is able to provide a written informed consent.
排除标准
- •Known sensitivity to local anaesthetics.
- •Significant liver or renal insufficiency.
- •Contraindication to regional anaesthesia e.g. local - sepsis, pre-existing peripheral neuropathies and coagulopathy.
- •Patient refusal.
- •Failed Block.
结局指标
主要结局
Onset of the Analgesic effect of TAP block with different additives
时间窗: 30 minutes
The patient will be asked to register a prick respectively on the upper extremity. Sensory change will then be assessed in the mid-clavicular line, starting above dermatome T4 moving caudally to dermatome L4.
次要结局
- Time of first analgesic request(24 hours)
- Block related complications(24 hours)
- Dose of intra-Operative fentanyl consumption(2 hours)
- Incidence of postoperative nausea and vomiting(24 hours postoperative)
研究者
Bassant M. Abdelhamid
Professor
Cairo University