A Randomized Controlled Non-Inferiority Trial Comparing Thoracic Paravertebral Block and Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Video-Assisted Thoracoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Cumulative IV Morphine Milligram Equivalents (IV-MME) in the First 24 Hours After Surgery
研究概览
简要总结
The purpose of this study is to find out which pain relief method works better for people having video-assisted thoracoscopic surgery. We will compare two techniques: thoracic paravertebral block (TPVB), a numbing injection near the spine, and intrathecal morphine (ITM), a small dose of morphine injected into the spinal fluid. We want to see if ITM works as well as TPVB in reducing the need for pain medicine during the first 24 hours after surgery. People in the study will get either TPVB or ITM before going to sleep for surgery, use a patient-controlled pain pump after surgery, and have their pain scores, medicine use, recovery, and possible side effects checked for up to 30 days after surgery.
详细描述
This study will compare two different pain control techniques for people having video-assisted thoracoscopic surgery (VATS), a minimally invasive chest operation. The first technique, called thoracic paravertebral block (TPVB), involves injecting numbing medicine near the spine to block pain from the surgical area. The second technique, intrathecal morphine (ITM), involves giving a small dose of morphine into the spinal fluid to provide pain relief after surgery.
The main goal is to find out if ITM works as well as TPVB in reducing the need for additional pain medicine during the first 24 hours after surgery. This is a randomized controlled trial, meaning participants will be randomly assigned to one of the two groups. Everyone will receive general anesthesia for their surgery and will use a patient-controlled analgesia pump afterwards, along with regular pain medicines such as paracetamol and tenoxicam.
Pain scores, the amount of pain medicine used, and recovery quality will be measured at regular times in the first 24 hours after surgery. We will also monitor side effects such as nausea, vomiting, itching, or breathing problems. All patients will be followed for 30 days after surgery to check for any complications.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled for elective video-assisted thoracoscopic surgery (VATS) for wedge resection, segmentectomy, or lobectomy
- •Ability to understand the study protocol and provide written informed consent
排除标准
- •Refusal to participate
- •Morbid obesity (body mass index > 30)
- •Known allergy to opioids, local anesthetics, or NSAIDs
- •History of neuropsychiatric disorder, cognitive impairment, or inability to communicate with investigators
- •History of substance abuse
- •Current anticoagulant use or known bleeding disorder
- •Presence of systemic infection
- •Significant cardiovascular, hepatic, renal, or endocrine disease
- •History of chronic pain syndromes or chronic pain treatment
- •Emergency surgery or previous ipsilateral VATS or thoracotomy
- •Preoperative chronic opioid therapy within 3 months (≥15 mg/day for ≥30 days)
- •Severe intraoperative or postoperative bleeding, hemodynamic instability
- •Requirement for prolonged postoperative ventilation (> 18 hours)
研究组 & 干预措施
Thoracic Paravertebral Block (TPVB)
Patients in this group will receive a single-injection ultrasound-guided thoracic paravertebral block before induction of standardized general anesthesia. The block will be performed using 0.4 mL/kg of 0.25% bupivacaine with epinephrine (1:400,000). Postoperatively, patients will receive intravenous patient-controlled analgesia with morphine, along with scheduled paracetamol and NSAIDs.
干预措施: Thoracic paravertebral block (Procedure)
Intrathecal Morphine (ITM)
Patients in this group will receive a single dose of intrathecal morphine (5 mcg/kg diluted in 3 mL 0.9% saline) at the L3-L4 or L4-L5 interspace before induction of standardized general anesthesia. Postoperatively, patients will receive intravenous patient-controlled analgesia with morphine, along with scheduled paracetamol and NSAIDs.
干预措施: Morphine (Drug)
结局指标
主要结局
Cumulative IV Morphine Milligram Equivalents (IV-MME) in the First 24 Hours After Surgery
时间窗: First 24 hours postoperatively
Total amount of intravenous morphine milligram equivalents (IV-MME) administered during the first 24 postoperative hours.
次要结局
- Cumulative IV Morphine Milligram Equivalents (IV-MME) in the First 12 Hours After Surgery(First 12 hours postoperatively)
- Time to First Analgesic Request(From extubation and recovery of communication ability to first PCA demand, within 24 hours postoperatively)
- Numeric Rating Scale (NRS) Pain Scores at Rest(0, 3, 6, 12, 18, and 24 hours postoperatively)
- Numeric Rating Scale (NRS) Pain Scores During Coughing or Deep Breathing(0, 3, 6, 12, 18, and 24 hours postoperatively)
- Sedation Score(0, 3, 6, 12, 18, and 24 hours postoperatively)
- Postoperative Nausea and Vomiting (PONV) Score(0, 3, 6, 12, 18, and 24 hours postoperatively)
- Incidence of Postoperative Complications(First 30 postoperative days)
- Pruritus Score(0, 3, 6, 12, 18, and 24 hours postoperatively)
- Rescue Analgesia Requirement(First 24 hours postoperatively)
- Quality of Recovery questionnaire (QoR-15) score(Preoperative baseline (≤24 h before surgery), 24 h postoperatively, and at hospital discharge (anticipated within 3 days))
- Intraoperative Remifentanil and Propofol Consumption(Intraoperative period (from induction to 240 min))
- Intraoperative Hemodynamics (Heart Rate and Mean Arterial Pressure)(Intraoperative period (from induction to 240 min))
研究者
Cengiz KAYA
Prof. Dr.
Ondokuz Mayıs University