Preoperative Paravertebral Block in Cancer Surgery of the Lung: ParaSOL a Prospective Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Moderate-to-severe pain Numerical Rating Scale (NRS) >/=3
研究概览
简要总结
The investigators aim to determine whether ultrasound-guided preemptive paravertebral blockade (PVB) local anaesthetic (pre-PVB LA), administered in addition to the post-operative PVB (post-PVB) local anaesthetic (LA) infusion, reduces acute postoperative pain, opioid requirement, chronic pain, and improves surgical recovery, in thoracoscopic surgery for lung cancer.
详细描述
In the UK, there has been an increase in lung cancer operations, especially in high risk and elderly patients, improving survival from 10.6% in 2008 to 15.1% in 2013. Lung cancer surgery is associated with severe acute pain, a high incidence of respiratory complications and chronic post-surgical pain. Severe acute postoperative pain is a strong predictor of CPSP. The improvement of perioperative outcomes in elderly patients, the benefits of regional anaesthesia and reduction of chronic pain are investigative priorities of the Anaesthesia and Perioperative Care Setting Partnership.
Enhanced recovery strategies include video-assisted thoracoscopic surgery (VATS), a minimally invasive alternative to open thoracotomy, which may be associated with less postoperative pain. Regional anaesthesia, by thoracic epidural analgesia (TEA) or PVB, is superior to systemic opioids in reducing acute pain after thoracotomy surgery.
Preemptive analgesia describes the aim of minimizing central spinal pain transmission by noxious stimuli arising from events at surgery, by administering an analgesic technique prior to surgical incision. Regional blockade affects central sensitization, allowing analgesia to outlast the pharmacological sensory blockade.
Compared to TEA initiated after surgery, acute pain severity is reduced by preemptive TEA. There are conflicting reports on the benefit of preemptive analgesia in other types of surgery, but TEA and PVB may prevent CPSP in thoracotomy and breast surgery. Some small studies have shown that pre-PVB reduces acute postoperative pain.
Paravertebral blockade is known to be as effective as TEA for acute postoperative analgesia following thoracic surgery, whilst having a lower incidence of pulmonary complications, hypotension and nausea. It is conventional practice in many centres for the surgical administration and placement of a catheter at the end of surgery for postoperative LA infusion (post-PVB) as the sole method of regional analgesia. Preoperative PVB is less common: anaesthetists may use a landmark technique, single or multiple injections and different volumes/strengths of LA.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be randomised on the day of surgery to the 'pre-PVB LA' or 'pre-PVB saline' arm, by a study investigator, with a 1:1 randomisation ratio using 'Sealed Envelope' (www.sealedenvelope.com) online software. Each subject will receive a unique randomization code in an envelope that will only be opened during the preparation of the pre-PVB injectate.
A non-blinded research nurse, will prepare the pre-PVB injectate in a standard syringe according to the allocation, labelled by participant number, in a theatre location concealed from the operating room and staff.
The anaesthetist, the surgeon and theatre team, recovery staff, and the researchers performing all the outcome assessments will be separate and blinded to the group allocation. The PVB catheter will be taped as normal before connecting the post-PVB LA infusion pump.
We have elected to perform an interventional placebo intervention as opposed to a sham control to minimize observer bias.
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
- •Elective radical primary lung cancer VATS surgery for single lobectomy
- •American Society of Anesthesiology (ASA) I-III
排除标准
- •Planned open thoracotomy, wedge resection, bilobectomy, pneumonectomy, chest wall resection or total pleurectomy
- •Local anaesthetic or opioid allergy
- •Coagulation disorders
- •Inability to comply with study questionnaire completion
- •Pre-existing pain in chest area or pre-existing pain conditions
- •Local infection/tumour at proposed PVB site
- •Previous lung surgery
- •Planned surgery within 3 months of the primary lung resection
研究组 & 干预措施
Pre-PVB with saline
Placebo (20ml Saline) pre-PVB performed post-induction and pre-incision.
干预措施: 0.9% Sodium Chloride 20mL Injection (Drug)
Pre-PVB with 0.5% Levo-bupivacaine
20ml 0.5% Levo-bupivacaine pre-PVB performed post-induction and pre-incision.
干预措施: Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection (Drug)
结局指标
主要结局
Moderate-to-severe pain Numerical Rating Scale (NRS) >/=3
时间窗: 1 day
The proportion of patients with clinical relevant moderate-to-severe pain (NRS\>/=3) related to the surgical site at rest at 24 hours.
次要结局
- Time to first mobilization(3 days)
- Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.(48 hours)
- Cumulative morphine requirement(48 hours)
- Length of hospital stay(3 days)
- Incidence of in-hospital complications(3 days)
- Presence of chronic post-surgical pain(Measured at 3 and 6 months post-operatively)
- Quality of Life (QoL) score(Pre-operative and at 3 and 6 months post-operatively)