Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery (VATS): Analgesic Effectiveness and Role in Fast-track Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Intensity of postoperative pain
研究概览
简要总结
This study is designed to assess:
- The impact of continuous thoracic paravertebral nerve blockade compared to intercostal nerve blockade on the intensity of postoperative pain following VATS in subjects having a Patient Controlled Analgesia (PCA) device as their primary analgesic modality.
- The impact of continuous thoracic paravertebral analgesia on length of stay, opioid intake, respiratory function, incidence of side-effects and postoperative complications.
The basic hypothesis of this study is that continuous thoracic paravertebral nerve blockade will provide superior postoperative analgesia following VATS when compared to intercostal nerve blockade in patients having a PCA device as their primary analgesic modality. Superior quality of analgesia should contribute to preserve pulmonary function, reduce opioid intake and related side-effects and shorten the hospital stay.
详细描述
Appropriate postoperative analgesia is crucial in fast-track surgery, which is a multimodal therapeutic strategy that aims toward enhanced postoperative recovery and shortened hospital stay. Although VATS is considered a minimally invasive procedure, patients have reported moderate to severe pain of variable duration following surgery. The ideal postoperative analgesia regimen for VATS has not been elucidated. Systemic opioids given through patient-controlled devices (PCA) are routinely used after these procedures but their analgesic effect can be limited and undesirable side-effects may occur. Intercostal nerve blockade is also widely used to alleviate pain following VATS and can be used as an adjunct to systemic opioids. Paravertebral nerve blockade is an interesting alternative for analgesia following VATS. The duration of pain relief associated with paravertebral nerve blockade may vary from 4 to 48 hours. However, the duration of the analgesic effect can be prolonged using a continuous infusion of local anesthetics.
This study will compare the efficacy of continuous ambulatory paravertebral analgesia to intercostal analgesia. All patients will have a PCA device as their primary analgesic modality.
Methods:
Seventy patients will be randomized to receive either continuous paravertebral analgesia or intercostal analgesia. Anesthetic technique and monitoring will be standardized.
On arrival in the recovery room, each patient will have a PCA device installed. PCA doses will be standardized. All patients will also receive acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDS) as co-analgesia. PCA will be removed 24 hours after surgery and oral opioids will then be administered as needed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for an elective or emergency VATS surgery (lobectomy or bilobectomy)
- •Patients eligible for fast-track surgery
- •American Society of Anesthesiologists (ASA) physical status from 1 to 3
排除标准
- •Contraindication to paravertebral nerve blockade
- •Severe hepatic insufficiency
- •Renal insufficiency
- •Known allergy to local anesthetics, morphine or hydromorphone
- •Contraindication to acetaminophen or non-steroidal anti-inflammatory drugs (NSAID)
- •Inability to understand a verbal numeric pain scale despite previous instruction
- •Inability to understand the instructions and precautions related to the use of a portable infusion pump or absence of a resource person or natural caregiver at home
- •Preexisting pain at the site where the surgical incision will be made
- •Current use of opioids, anticonvulsants or tricyclic antidepressants
- •Recent history of drug or opioid abuse
研究组 & 干预措施
Paravertebral analgesia
A paravertebral nerve block will be performed under ultrasound guidance by the anaesthesiologist prior to the induction of general anesthesia. A catheter will be inserted and a continuous infusion of bupivacaine will be administered.
干预措施: Continuous infusion of bupivacaine (Drug)
Intercostal analgesia
An intercostal nerve block using a single dose of bupivacaine will be performed by the surgeon at the end of surgery before skin closure.
干预措施: Single dose of bupivacaine (Drug)
结局指标
主要结局
Intensity of postoperative pain
时间窗: 24 hours following surgery
Will be assessed using a Verbal Numeric Pain Scale (VPNS) from 0 to 10: 0 being no pain at all and 10 being the worst pain imaginable
次要结局
- Length of stay in the hospital(From surgery until discharge from the hospital, approximately 2 days)
- Lung function(Immediately prior to surgery and daily from surgery until discharge from the hospital, approximately 2 days)
- Opioid intake(From surgery until 72 hours following surgery)
- Side-effects attributable to analgesia(From surgery until 72 hours following surgery)
- Patient's satisfaction with pain relief(Daily from surgery until 72 hours following surgery)
- Length of stay in the recovery room(At discharge from recovery room, approximately 1 hour after end of surgery)
- Length of stay in the intermediate intensive care unit(From discharge from the recovery room until discharge from the intermediate intensive care unit, approximately one day.)
- Pulmonary complications(From surgery until 72 hours following surgery)
- Time to reach discharge criteria(From the day after surgery until discharge from the hospital, approximately 2 days)
- Intensity of postoperative pain(72 hours following surgery)