QORVATS Study. A Randomized Controlled, Triple Blinded to Compare the Quality of Recovery (QoR 40) Between Intercostal Block and a Combination of Intercostal Nerve Block With Serratus Plane Catheter for Patient's Undergoing VATS Procedures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Quality of Recovery
研究概览
简要总结
Video assisted thoracic surgery (VATS) has emerged as standard of care for majority of thoracic surgeries. It is less invasive compared to thoracotomy and is associated with improved perioperative outcomes [1-3]. Good perioperative analgesia after thoracic surgery will enable pulmonary toilet, early chest physiotherapy and mobilisation, [4,5,6]. Thirty-day hospital visits and hospital readmissions at London Health Sciences Centre (LHSC) is around 21% and 9% respectively [7]. One of the top five determinant for hospital visit and readmission in 30 days, was persistent post operative pain [7].
Several options to analgesia are available for patients undergoing VATS procedure. Systemic opioid based multimodal analgesia, central neuraxial blocks like thoracic epidural and peripheral nerve blocks are different available options, and their practise varies across institution [4,8,9]. Thoracic epidural or paravertebral blocks can be challenging to perform with high failure rates [10-12].
Fascial plane blocks (SAB; ESP) are in vogue in the present era [13-16]. They are easy to perform and do not require similar dexterity as needed to perform thoracic epidural or paravertebral blocks. They have minimal side effects and provide the options for continuous infusion for prolonged analgesia. They have become an effective part of multimodal analgesia and have established their roles in ERAS (enhanced recovery after surgery) protocol for VATS procedures.
SAB has become a common practise at our institution with proved clinical efficacy.
Perioperative Surgical Home is a patient centric team-based approach to improve patient's experiences in the perioperative period and thus improve healthcare [17]. Quality of Recovery (QoR) is a key determinant to perioperative surgical home and can be measured using the QoR 40 score [18]. This is a well validated score with a minimal important clinical difference (MICD) of 6.3 [19]. Quality of recovery combines five dimensions of health: patient support, comfort, emotions, physical independence and pain to achieve a single patient outcome - improved patient care [18].
The investigators hypothesize the that patients undergoing VATS lung resections using a combination of intercostal nerve block plus continuous SAB catheter infusion of local anesthetics will have a 20% increase in their QoR-40 score 24hour after the surgery compared to a single shot intercostal nerve block.
详细描述
This is a prospective randomized controlled triple-blind study. There will be two study groups. All study participants will receive SAB with catheter for continuous infusion and intercostal block. Depending on the group allocation, the study participants may receive local anesthetics or placebo for the block.
Participants depending on the group allocation, will either receive ropivacaine 0.2% or equal volume of normal saline (placebo) solutions for the nerve blocks. This is meant to maintain participant, clinical team, and investigator blinding. The anesthetist(s) performing the block will be blinded to the intervention along with the anesthetists performing the general anesthesia and the surgical team. Importantly, the intraoperative and postoperative opioids will be administered by anesthetists and nurses, respectively, who are blinded to group allocation. Furthermore, the research coordinator collecting all outcome data will also be blinded Interventions Intraoperative anesthetic managements will depend on the anesthesiologists in care of the patient on that day and will be based on standard of institutional practise and Canadian anesthesia society guidelines irrespective of patient study participation. Intraoperatively, the patient will receive Opioids or NSAIDS on discretion of the anesthesiologists depending on the clinical need. To standardize the perioperative multimodal analgesic management and to reduce biases, none of these patients will receive any ketamine or gabapentin during the perioperative period. All the study interventions will be performed after completion of surgery and when the patient is still under anesthesia. After the completion of surgery, with patient still on lateral decubitus, surgical site being non dependant, the thoracic wall will be cleaned with 2% chlorhexidine solution and draped aseptically to maintain a sterile environment. The intercostal block will be completed by the surgical team while the serratus catheter will be performed by one of the anesthesiologist coinvestigators. The study drugs will be prepared by a different co-investigator and the anesthesiologists performing the block or providing general anesthesia for the patient will not be aware of the content of the study drugs.
Patients will be recovered from anesthesia once the blocks are complete and transferred to PACU for recovery. All the patients will receive opioid based patient-controlled analgesia (PCA) with hydromorphone or morphine only along with acetaminophen in the postoperative period. These are standard of care at LHSC. The participants will also receive 0.2% ropivacaine infusion 7 mL/hr or normal saline infusion 7mL/hr depending on the study group. Their postoperative pain will be managed by the acute pain services as per standard hospital guidelines irrespective of their study participation.
One of the study team members will access the patient in the postoperative period (PACU and once daily) until discharge for data collection.
Intercostal nerve block The intercostal block will be performed by the surgical team under direct vision using thoracoscope. 5 mL of 0.2% ropivacaine will be injected at each 4th,5th,6th and 7thintercostal nerve at posterior axillary line. After full asepsis and placement of thoracoscope respective ribs will be palpated to identify the inferior border and neuronal anatomy will be identified using video assistance thoracoscope. Study drugs will be injected at the inferior border at midaxillary line at each space. Total volume of study drugs injected will be 20 mL.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participant, treating anesthesiologist and surgical team, and outcomes assessor will be blinded to prevent bias. One of the study team co-investigators who is not the treating anesthesiologist during the participants's surgery will prepare the study drugs. The treating anesthesiologist will not be aware of the contents of the study drugs.
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
- •Patients undergoing elective VATS lung resections including wedge resection, segmentectomy, bi-lobectomy, or lobectomy.
- •Age > 18 years.
- •ASA (American Society of Anesthesiology) Score - 1 to
- •Gender - all genders
- •Patients able to consent to participate in the study
排除标准
- •Patient refusal to participate in the study.
- •Emergency surgery.
- •Allergies to local anesthetics
- •Presence of local (chest wall) or systemic infection.
- •Previous lung resection on the same hemithorax.
- •Patient suffering from chronic pain defined by persistent pain more than six month.
- •Conversion to thoracotomy
研究组 & 干预措施
Serratus Plane Block (Local Anesthetic) and Intercostal Block (Local Anesthetic)
Patients randomized to this group will receive the intercostal block with local anesthetic and the serratus plane block with local anesthetic. Local anesthetic administered will be ropivacaine 0.2%.
干预措施: Serratus Plane Block (Local Anesthetic) and Intercostal Block (Local Anesthetic) (Procedure)
Serratus Plane Block (Placebo) and Intercostal Block (Local Anesthestic)
Patients randomized to this group will receive the intercostal block with local anesthetic and the serratus plane block with saline placebo. Local anesthetic administered will be ropivacaine 0.2%.
干预措施: Serratus Plane Block (Placebo) and Intercostal Block (Local Anesthestic) (Procedure)
结局指标
主要结局
Quality of Recovery
时间窗: Measured on postoperative day 1
Measured using the Quality of Recovery 40 (Qor-40) Score and asking patients to complete the questions.
次要结局
- Total opioid consumption(Until patient discharge, on average one week.)
- Hospital readmission(30 days postoperative)
- Postoperative pain scores(Until patient discharge, on average one week.)
- Postoperative complications after thoracic surgery(Immediately following surgery until discharge, on average one week.)
- Side effects(Until patient discharge, on average one week.)
研究者
Abhijit Biswas
Assistant Professor, Anesthesiologist
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
