Analgesic Efficacy of Erector Spinae Infusion Versus Thoracic Epidural Infusion of Bupivacaine for Postoperative Pain in Patients Undergoing Upper Abdominal Cancer Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- pain intensity measured by 11 points Visual Analogue Scale
研究概览
简要总结
Epidural analgesia is considered by many to be the reference standard which has been shown to reduce the intraoperative surgical stress response.
However, besides its excellent analgesic effect, there are some disadvantages associated with epidural analgesia. This includes the risk of epidural hematoma/abscess ,failure rates hypotension, urinary retention. Also the need for preoperative placement in awake patients, who seem to dislike and sometimes even refuse. It is contra-indicated in the presence of coagulopathy or local sepsis.
ESPB is a faster procedure that carries a lower risk of hypotension, can be used in patients with coagulopathy, easy to perform, and requires less training.
So this study is to compare the postoperative analgesic effect of continous bupivacaine infusion via thoracic epidural versus erector spinae catheters following upper abdominal cancer surgery.
详细描述
Surgical trauma activates numerous receptors leading to severe postoperative pain. Therefore, effective pain management is a priority of care and a patient right.
Postoperative pain may cause tachycardia, hypertension, increased cardiac work, nausea, vomiting, ileus. Also if it is inadequately managed may lead to detrimental Cardiovascular effects, pulmonary dysfunction, immune system, neuro-endocrine and metabolic effects, gastrointestinal, urinary dysfunction, coagulation system , cognitive dysfunction and also have psychological, economic and social adverse effects Good postoperative analgesia can prevent morbidity associated with abdominal surgeries by allowing pain-free, early ambulation and decreasing the risks of long hospital stay, thromboembolism, and other poor outcomes.
Adequate pain treatment is an important component of modern perioperative care and essential for a fast recovery. Choosing the optimal analgesic modality remains a topic of debate especially in major abdominal surgeries.
Epidural analgesia is considered by many to be the reference standard. It is used routinely in many thoracic surgery centers. Epidural blockade has been shown to reduce the intraoperative surgical stress response and has possible advantages for cardiovascular, respiratory, coagulation, gastrointestinal, metabolic and immune function However, besides its excellent analgesic effect, there are some disadvantages associated with epidural analgesia. This includes the risk of epidural hematoma/abscess (incidence 1:1,000-6,000 in surgical patients), failure rates of up to 30%, hypotension, urinary retention , in rare cases; paraplegia. Also the need for preoperative placement in awake patients, who seem to dislike and sometimes even refuse . It is contra-indicated in the presence of coagulopathy or local sepsis.
In the last decade, there has been a significant shift away from thoracic epidural analgesia (TEA) that has been long considered as the gold standard.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients subjected to major upper abdominal cancer surgery.
- •The enrolled age will be from 18 years to 70 years
- •ASA I-II and NYHA I-II.
排除标准
- •ASA physical status >II, and NYHA >II
- •Patient refusal
- •body mass index >40 kg/m2
- •preoperative opioid consumption
- •a local infection at the incision site
- •a history of hematological disorders or coagulation abnormality
- •previous abdominal surgeries, severe hepatic or renal impairment
- •Anomalies of vertebral column.
- •Pregnant women
- •Hypersensitivity to any of used drugs
- •chronic pain
结局指标
主要结局
pain intensity measured by 11 points Visual Analogue Scale
时间窗: immediately postoperative for 48 hours after surgery.
to assess pain intensity at rest and during pain-provoking movements (deep breathing, coughing, mobilization) measured by 11 points Visual Analogue Scale (VAS) score in which 0 indicates no pain and 10 indicates the severest pain
次要结局
- Hemodynamic variable measured by heart rate in beats per minute(immediately postoperative for 48 hours after surgery.)
- Hemodynamic variable measured by blood pressure in mmHG(immediately postoperative for 48 hours after surgery.)
研究者
Mohamed Hussein Mahmoud
assistant lecturer
Assiut University
