Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients: A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total intraoperative fentanyl consumption.
研究概览
简要总结
Ultrasound imaging has revolutionized the practice of regional anesthesia in that the operator can visualize and identify the paravertebral space, needle during its passage through the tissues, as well as deposition and spread of local anesthetic into the desired spaces. The usage of ultrasound may facilitate more rapid block onset and prolong duration with the added advantage of decrease in drug dosage, reduction in incidence of local anesthetic toxicity, increase success rate, reduction in procedure pain and better patient satisfaction.
详细描述
Paravertebral block targets drug delivery to the site of pain, thus decreasing opioids use. It can provide greater overall comfort with lower pain scores and greater tolerance of physical activity during the initial postoperative period.
Ultrasound imaging has revolutionized the practice of regional anesthesia in that the operator can visualize and identify the paravertebral space, needle during its passage through the tissues, as well as deposition and spread of local anesthetic into the desired spaces. The usage of ultrasound may facilitate more rapid block onset and prolong duration with the added advantage of decrease in drug dosage, reduction in incidence of local anesthetic toxicity, increase success rate, reduction in procedure pain and better patient satisfaction.
To the best of researchers' knowledge, evaluation of unilateral ultrasound guided paravertebral block as perioperative analgesia for lower limb-sparing surgery in adult cancer patients was not investigated before.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
sealed opaque envelopes prepared by an assistant blinded about the study targets and chosen by patient him/herself, allocated into two groups
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
- 是
入选标准
- •Physical status ASA II and III.
- •Age ≥ 18 and ≤ 65 Years.
- •Body mass index (BMI): > 20 kg/m2 and < 40 kg/m
- •Patient undergoing lower limb-sparing surgery for cancer surgeries under general anesthesia.
排除标准
- •Patient refusal.
- •Known sensitivity or contraindication to local anesthetics.
- •History of psychological disorders and/or chronic pain.
- •Coagulopathies with INR ≥1.5: hereditary (e.g. hemophilia, fibrinogen abnormalities & deficiency of factor II) - acquired (e.g. impaired liver functions with PC less than 60 %, vitamin K deficiency & therapeutic anticoagulants drugs).
- •Significant liver or renal insufficiency.
- •Localized infection at the site of block.
结局指标
主要结局
Total intraoperative fentanyl consumption.
时间窗: 24 hours
Total intraoperative fentanyl consumption.
次要结局
- Visual Analouge Scale at 0 , 4 , 8 ,12 ,24 hours postoperatively.(24 hours)
- Heart rate and mean arterial blood pressure .(24 hours)
- Morphine consumption postoperatively for 24 hours..(24 hours Postoperative)
研究者
Ahmed Abdalla
Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University
Cairo University