A prospective interventional pilot study comparing pain relief following an ultrasound-guided Serratus Anterior Plane block in patients undergoing minimally invasive esophagectomy at a tertiary care cancer center, versus retrospectively collected data on standard acute pain management practices
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- NRS
研究概览
简要总结
The study will be a prospective interventional study in which we will be giving an injection of Local anaesthetic preferably levo-bupivacaine beneath the servalis anterior muscle more commonly known as the Serratus anterior plane block or the SAP block. The block shall be given in individuals undergoing minimally invasive surgery for esophageal cancer at a tertiary care cancer centre. Post surgery we will be observing the pain relief of the patient and measure the postoperative pain with the help of Numerical Rating scale and patient’s Maximum inspiratory volume at specified time intervals . As a part of the study we shall also be noting down the time when the patient experienced pain for the first time post surgery and the time at which the first rescue analgesic was administered. All patients will be receiving PCM 15mg/kg and diclofenac 1mg/ kg Intraoperatively apart from the block .
The data thus obtained shall be compared with the retrospective data maintained on the standard acute main management practices
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 80 years undergoing MIS esophagectomy.
排除标准
- •Patient’s refusal.
- •Infection at the site of needle insertion.
- •Previous allergic reactions to local anaesthetic (levobupivacaine) and/or paracetamol and/or diclofenac and/or fentanyl.
- •Contraindications to receive paracetamol (liver enzymes more than 5 times the normal values, Child- Pugh B or C) or diclofenac (serum creatinine more than 1.5 mg percent, single-kidney status, blood loss during the surgery more than 1.5 litres, history of aspirin-induced bronchial asthma)
- •Pregnant Women.
- •Patients whom thoracic epidural is inserted with likely high chances of risk of converting into open thoracotomy.
结局指标
主要结局
NRS
时间窗: NRS- at rest, | NRS- on maximal spirometry effort at 1st 4 hours, 4-12 hours, and 24 hours after reaching the recovery room in the postoperative period
次要结局
- 1. Time to receive the first rescue analgesic following the MIS esophagectomy surgery.(2. Worst pain score in 24 hours following the surgery.)
研究者
Dr Bindiya Salunke
Tata Memorial Centre