Comparison of the Effectiveness of Intravenous Analgesia Protocols Used After the Duration of Block Action for Postoperative Pain Control in Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to compare the effectiveness of three different intravenous (IV) patient-controlled analgesia (PCA) regimens-Fentanyl, Tramadol, and Ibuprofen-in managing postoperative pain and respiratory performance in patients undergoing Video-Assisted Thoracoscopic Surgery (VATS). While regional blocks like Erector Spinae Plane (ESP) block provide effective early analgesia, their effect typically diminishes after 8-12 hours, leading to potential 'rebound pain.' This study specifically investigates the period following the duration of the regional block's action. The primary goal is to evaluate which IV PCA protocol better controls pain (Visual Analog Scale scores) and supports better respiratory performance (measured by incentive spirometry) during the first 72 hours post-surgery
详细描述
Thoracic surgery is associated with one of the highest incidences of both acute and chronic postoperative pain. Clinical evidence indicates that poorly controlled acute pain in the immediate postoperative period is a primary risk factor for the development of chronic neuropathic pain (post-thoracotomy pain syndrome). Furthermore, severe acute pain triggers a guarding reflex, leading to shallow breathing, impaired coughing, and ultimately compression atelectasis.
In alignment with the 2026 American Society of Anesthesiologists (ASA) guidelines, this study emphasizes a multimodal, opioid-sparing approach to optimize patient recovery. While regional techniques like the Erector Spinae Plane (ESP) block offer effective early analgesia, their effectiveness is typically limited to 8-12 hours. This study evaluates the effectiveness of three different IV Patient-Controlled Analgesia (PCA) regimens initiated specifically to bridge the analgesic gap after the regional block's effect diminishes.
Interventions:
All patients receive a standardized ultrasound-guided ESP block (20 ml 0.25% bupivacaine) at the end of surgery. PCA regimens (Fentanyl, Tramadol, or Ibuprofen) are initiated at the 6th postoperative hour (or earlier on patient demand). Postoperative static and dynamic pain scores (VAS), rescue analgesic requirements and respiratory performance (incentive spirometry volumes) are monitored for 72 hours.
The study hypothesizes that the Ibuprofen-based PCA will maintain comparable analgesia to opioid-based regimens while significantly improving respiratory performance by avoiding opioid-induced respiratory depression.
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
- Double (Participant, Outcomes Assessor)
盲法说明
While the primary investigator responsible for the administration and adjustment of the Patient-Controlled Analgesia (PCA) devices was aware of the group assignments, the patients were blinded to the specific drug they received. Furthermore, the researchers who recorded the Visual Analog Scale (VAS) scores and measured the incentive spirometry volumes at each visit were blinded to the treatment groups.
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 aged 18 to 80 years.
- •- ASA (American Society of Anesthesiologists) Physical Status Score of I-III.
- •- Body Mass Index (BMI) between 18 and 35 kg/m².
- •- Undergoing elective thoracic surgery via Video-Assisted Thoracoscopic Surgery (VATS).
- •- Voluntary participation confirmed by signing the written Informed Consent Form.
排除标准
- •- Age below 18 or above 80 years.
- •- Advanced organ failure (e.g., severe hepatic or renal impairment).
- •- ASA physical status > III.
- •- History of chronic pain treatment or long-term opioid use.
- •- BMI < 18 kg/m² or > 35 kg/m².
- •- Pregnancy or breastfeeding.
- •- Limited cooperation due to dementia or uncontrolled psychiatric disorders.
- •- Communication barriers (inability to communicate in the native language).
- •- History of substance or drug abuse.
- •- Known allergy or contraindication to the study drugs (Fentanyl, Tramadol, or Ibuprofen).
- •- Contraindication to regional block placement (e.g., infection at the injection site).
研究组 & 干预措施
Group T (Tramadol Group)
Patients in this group are assigned to receive IV PCA using a tramadol solution. Similar to Group F, the protocol is initiated at the 6th postoperative hour or at the first analgesic demand. This arm represents the weak opioid-based approach.
干预措施: Tramadol IV PCA (Drug)
Group I (Ibuprofen Group)
Patients in this group are assigned to receive IV PCA using an ibuprofen solution. Similar to Group F and T, the protocol is initiated at the 6th postoperative hour or at the first analgesic demand. This arm is the non-opioid, NSAID-based treatment group.
干预措施: Ibuprofen IV PCA (Drug)
Group F (Fentanyl Group)
Patients in this group are assigned to receive intravenous (IV) Patient-Controlled Analgesia (PCA) using a fentanyl solution. The treatment is initiated either at the 6th postoperative hour or upon the first request for analgesia (VAS >4). This arm is the potent opioid-based treatment group.
干预措施: Fentanyl IV PCA (Drug)
研究者
Barış Turunç
MD
Ankara Etlik City Hospital