Comparison of the Effects of Serratus Posterior Superior Intercostal Plane Block and Intrathecal Morphine on Postoperative Acute Pain in Patients Undergoing Video-assisted Thoracoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cumulative IV-MME during the first 24 hours after postoperative admission following extubation
研究概览
简要总结
This study aims to compare the analgesic effects of the serratus posterior superior intercostal plane block and intrathecal morphine in patients undergoing video-assisted thoracoscopic surgery.
This is a prospective, randomized, controlled, single-center clinical trial including adult patients undergoing elective thoracoscopic surgery. Participants will be randomly assigned to receive either a serratus posterior superior intercostal plane block or intrathecal morphine before general anesthesia.
The primary outcome is cumulative opioid consumption during the first 24 postoperative hours, expressed as intravenous morphine milligram equivalents. Secondary outcomes include pain scores, time to first analgesic request, quality of recovery, and postoperative complications.
The study aims to determine whether these two techniques differ in their effectiveness for postoperative pain management.
详细描述
This study is a prospective, randomized, controlled, single-blinded, parallel-group clinical trial designed to compare the analgesic efficacy of serratus posterior superior intercostal plane block and intrathecal morphine in patients undergoing video-assisted thoracoscopic surgery.
Eligible patients aged 18-75 years with American Society of Anesthesiologists physical status I-III scheduled for elective thoracoscopic procedures (wedge resection, segmentectomy, or lobectomy) will be included. Patients will be randomized in a 1:1 ratio using a computer-generated sequence with block randomization.
Participants in the serratus posterior superior intercostal plane block group will receive an ultrasound-guided regional block prior to the induction of general anesthesia. Participants in the intrathecal morphine group will receive an intrathecal morphine injection before general anesthesia. All patients will receive standardized general anesthesia and postoperative patient-controlled analgesia.
The primary outcome is cumulative opioid consumption within the first 24 postoperative hours, expressed as intravenous morphine milligram equivalents.
Secondary outcomes include opioid consumption at 12 hours, numeric rating scale pain scores at rest and during activity, time to first analgesic request, quality of recovery scores, postoperative nausea and vomiting, sedation levels, pruritus, respiratory depression, and postoperative complications up to 30 days.
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
- Single (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 physical status I to III
- •Scheduled for elective video-assisted thoracoscopic surgery, including wedge resection, segmentectomy, or lobectomy
排除标准
- •Refusal to participate
- •Pregnancy
- •Morbid obesity (body mass index greater than 40 kg per square meter)
- •Allergy to study medications
- •Neuropsychiatric disorders, cognitive impairment, or inability to communicate
- •History of substance abuse
- •Active systemic infection or infection at the planned injection site
- •Severe cardiac, respiratory, hepatic, renal, or endocrine disease.
- •Chronic pain syndrome or ongoing chronic pain treatment
- •Emergency surgery or previous ipsilateral VATS or thoracotomy
- •Preoperative opioid use: ≥15 mg oral morphine equivalents/day for ≥30 days within the previous 3 months.
- •Anticipated need for postoperative mechanical ventilation.
- •Contraindications to neuraxial or peripheral regional anesthesia, including anticoagulant therapy, coagulopathy, infection, or relevant anatomical abnormalities.
研究组 & 干预措施
Intrathecal Morphine
Participants receive intrathecal morphine before induction of general anesthesia. Preservative-free morphine at 5 µg/kg based on ideal body weight is diluted with 0.9% saline to a total volume of 3 mL and administered intrathecally. All patients subsequently undergo standardized general anesthesia and receive postoperative patient-controlled analgesia with intravenous morphine.
干预措施: Intrathecal Morphine (Procedure)
Serratus Posterior Superior Intercostal Plane Block
Participants receive an ultrasound-guided serratus posterior superior intercostal plane block before induction of general anesthesia. A total of 30 milliliters of 0.25 percent bupivacaine with epinephrine is administered into the interfascial plane between the serratus posterior superior muscle and intercostal muscles. All patients subsequently undergo standardized general anesthesia and receive postoperative patient-controlled analgesia with intravenous morphine.
干预措施: Serratus Posterior Superior Intercostal Plane Block (Procedure)
结局指标
主要结局
Cumulative IV-MME during the first 24 hours after postoperative admission following extubation
时间窗: 24 hours
Total opioid consumption during the first 24 postoperative hours is expressed as intravenous morphine milligram equivalents, including patient-controlled analgesia and rescue analgesia.
次要结局
- Postoperative pain scores(0, 3, 6, 12, 18, and 24 hours postoperatively)
- Quality of recovery score(Preoperative baseline, 24 hours postoperatively, and at discharge)
- Sedation level(0, 3, 6, 12, 18, and 24 hours postoperatively)
- Respiratory depression(24 hours)
- Pruritus(0, 3, 6, 12, 18, and 24 hours postoperatively)
- Postoperative complications(30 days)
- Remifentanil consumption(Intraoperative period (from induction to end of surgery), up to 4 hours)
- Rescue analgesia requirement(24 hours)
- Propofol consumption(Intraoperative period (from induction to end of surgery), up to 4 hours)
- Time to first patient-controlled analgesia demand(24 hours)
- Postoperative nausea and vomiting(0, 3, 6, 12, 18, and 24 hours postoperatively)
- Cumulative IV-MME during the first 12 hours after postoperative admission following extubation(12 hours)
- Block-related complications(Up to 30 days postoperatively)
- Incidence of postoperative nausea and/or vomiting(24 hours postoperatively)
- Area under the numeric rating scale-time curve(0 to 24 hours postoperatively)
- Comprehensive Complication Index(Up to 30 days postoperatively)
研究者
Cengiz KAYA
Prof. Dr.
Ondokuz Mayıs University