PATHOS Study Pain Assessment in Thoracic Oncologic Surgery: a Prospective Randomized Trial on Pain Management After Video Assisted Major Lung Resections.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Post operative pain perception
研究概览
简要总结
A randomized prospective trial to assess whether the use of loco regional anesthesia as adjuvant analgesic therapy is more effective of intravenous analgesia only.
详细描述
A prospective randomized trial comparing intravenous analgesia alone and in association with loco regional anesthesia consisting in a homolateral Serratus Plan Block (SPB). Loco regional blockade of the serratus is further examined by allocating the patients to two different approaches: the block being performed under US guidance by the Anesthesiologist before the beginning of the procedure, or under direct visualization, by the operating surgeon, before entering the pleural cavity.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Given the trial Design, it would be impossible to blind the caregiver about the type of treatment.
Serratus Plan Block will be performed after the induction of General Anesthesia, the patients will thus be unaware wether being assigned to the Experimental or Control Arm.
Clarification (May 28, 2018):
- Nurses assess NRS (Pain Perception) and directly manage rescue doses delivery
- Physiotherapists deliver rehab. respiratory exercises and directly assess patient's performance.
Since their reports are directly elicited in Clinical Report Forms, they are considered outcome assessors.
Both Nurses and Physiotherapists are unaware of treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lobectomy/ Segmentectomy plus lymphadenectomy (systematic or sampling) for cancer (not necessarily NSCLC) performed with a standardized, three portal minimally invasive approach.
排除标准
- •Patients who are pregnant or lactating
- •Morbid obesity (BMI > 35 )
- •Inability to understand and sign the Informed consent
- •Proven allergy to local anesthetic drugs as required by this protocol
- •Patients under chronic analgesics or neuroleptic therapy for any reason and/ or with baseline pain score (NRS scale) of 3 or more.
研究组 & 干预措施
Serratus Plane Loco-regional block
- Continuous infusion of Tramadol 200 mg or Ketorolac 60 mg
- Rescue analgesia with Morphine (0.1 mg/kg) a single time every 24 hours, and/or Tramadol 100 mg up to three times every 24 hours and/ or Ketorolac 30 mg up to three times every 24 hours
plus
Ropivacaine (30 ml, 0.3%), for Serratus Plane Block
干预措施: Ropivacaine for Serratus Plane Block (SPB) (Drug)
结局指标
主要结局
Post operative pain perception
时间窗: 24 hours from the end of surgery
Direct request to the patient to define the pain feeling, according to a Numerical Rating Scale (NRS, 0 to 10).
次要结局
- Systemic rescue analgesia consumption (doses)(measured at 6 hrs, 12 hrs, 24 hrs, 36 hrs and 48hrs after surgery)
- Ability to perform post operative rehab exercises(Measured at 24 hrs and 48 hrs after surgery)