Optimization of Perioperative Analgesia Protocol for Uniportal Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- total opioid consumption
研究概览
简要总结
Trial design Despite video-assisted thoracic technology and procedure specific postoperative pain management (PROSPECT) have been promoted through recent years, thoracic surgery is still considered to be one of the most painful of surgical procedures. This study aims to optimize these conditions according to different perioperative analgesic modes recommended at present. This will be a single-blind randomized study to investigate the optimal analgesic effect of thoracic paravertebral block (TPB), erector spinae block (ESB), or sufentanil patient controlled intravenous analgesia (PCIA) for uniportal video-assisted thoracoscopic surgery (uVATS) and using minimally invasive drainage.
Methods One-hundred and two patients undergoing uVATS will be enrolled. Patients will be randomly assigned to PVB group (20mL 0.3% ropivacaine with dexamethasone), ESB group (20mL 0.3% ropivacaine with dexamethasone) or CON group. PCIA with sufentanil will be provided to all patients after surgery. Primary outcome will be total opioid consumption from the end of the surgery to the time of discharge. Secondary outcomes consist of postoperative pain score, postoperative chronic pain, both at rest and during coughing, sensations of touch and pain on the chest wall, non-opioid analgesic drug use, length of stay (LOS), ambulation time, total cost of hospitalization and long-term postoperative analgesia. Adverse reaction to analgesics and adverse event related to regional block will also be recorded.
Ethics and dissenmination This study is approved by the Ethics Committee of China-Japan Friendship Hospital (ID 2022-KY-127-1). The results will be published in peer-reviewed journals.
Key words: fast-track; Enhanced Recovery After Surgery; uniportal video-assisted thoracoscopic surgery; randomized controlled trial; thoracoscopic; ultrasonic guidance; paravertebral block; erector spinal block
详细描述
This is a prospective, randomized controlled study. Patients who are scheduled for elective uniportal thoracoscopic surgery in our hospital will be enrolled. Patients will be randomly assigned to one of the three groups: ultrasound-guided paravertebral block, ultrasound-guided erector spinae block, or intravenous patient-controlled analgesia pump group. Different nerve block operation schemes will be used in different groups.
In any of the three groups, general anesthesia will be performed according to the standard, and multi-mode analgesic treatment will be appied as the combination of NSAIDs analgesics, opioid analgesics, and postoperative rescue analgesic treatment. Participants will be followed up at 1, 4, 12, 18 hours, on 1, 2, 3, 4, 7 days, and in 1, 2, 3, 4, 6 months after surgery. At each follow-up visit, rest and cough pain level will be recorded, and sense of touch and pain in the chest will be examined. Additional analgesic treatment will be given if necessary.
Comparisons of the postoperative analgesic use, cough and rest pain, ambulation time, length of hospital stay, and hospital costs will be made in the three groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients will be grouped by block randomization method (1:1:1) by a researcher who is unaware of the meaning of the group code. Patients will be stratified by ID numbers with a block of 6. Within each block, random sequences between 0 and 1 are generated. The group code (A, B or C) will be defined as the remainder of the serial number divided by three. The group code will be put in a light-proof envelope. Patients with the envelope will be transferred to the OR, unaware of the group assignment throughout the study. After induction, the anesthesiologist opens the light-proof envelope and get the group code. Group codes will be recorded in the CRF table with the cards destroyed. Only the principal investigator and the anesthesiologists know the intervention represented by the group code. The anesthesiologists will not involve in postoperative follow-ups or data collection. Neither doctors in charge of postoperative follow-ups nor the statisticians will know the specific interventions.
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
- •Early stage lung cancer or intrathoracic tissue biopsy, suitable for elective uVATSb
- •Informed consent obtained
排除标准
- •History of intrathoracic or chest wall surgery
- •Chronic pain
- •Pre-operative analgesic medication use
- •NSAIDsc contraindications: aspirin asthma, allergic to NSAIDs, peptic ulcer, liver and kidney insufficiency, high risk of thrombotic events
- •Active autoimmune disease
- •Allergic to local anesthetics
- •Severe coagulation dysfunction, contraindicated for nerve block
- •Soft tissue infections of the chest wall
研究组 & 干预措施
PVB+PCIA group
干预措施: Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pump (Procedure)
PVB+PCIA group
干预措施: Patient-controlled intravenous analgesia pump (Procedure)
ESB+PCIA group
干预措施: Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pump (Procedure)
ESB+PCIA group
干预措施: Patient-controlled intravenous analgesia pump (Procedure)
PCIA group
干预措施: Patient-controlled intravenous analgesia pump (Procedure)
结局指标
主要结局
total opioid consumption
时间窗: up to 6 months, total opioid use from postoperative period till the discontinuation of surgery-related therapy.
total opioid (morphine equivalent/body weight) consumption from the end of the surgery to the time of discharge.
次要结局
- chest tube removal time(from the time at the end of surgery to 24 weeks after surgery)
- non-opioid analgesic drug use(from the time at the end of surgery to 24 weeks after surgery)
- length of stay (LOS)(up to 1 month, LOS is the amount of days the patient spends in the hospital, determined by subtracting the date of admission from the date of discharge)
- postoperative pain score assessed by Numeric Rating Scales, NRS (1-10)(from the time at the end of surgery to 24 weeks after surgery)
- ambulation time(up to 1 month, ambulation time is the time the patient first ambulated following the surgical procedure)
- long-term postoperative analgesia(from the time at the end of surgery to 24 weeks after surgery)
- postoperative pain score assessed by Visual Analogue Scale VAS (1-10)(from the time at the end of surgery to 24 weeks after surgery)
- sensations of touch on the chest wall(from the time at the end of surgery to 24 weeks after surgery)
- adverse events(from the time at the end of surgery to 24 weeks after surgery)
- total cost of hospitalization(up to 1 month, total charges settled on the day of discharge)
研究者
Li Fang Wang
attending doctor
China-Japan Friendship Hospital