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临床试验/NCT07694141
NCT07694141招募中不适用

Postoperative Analgesia in Patients Undergoing Thoracic Surgery

Hospital Universitario de Gran Canaria Doctor Negrín1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
Postoperative pain

研究概览

简要总结

Analgesic management in thoracic surgery presents a particular challenge for the anesthesiologist, given the intensity of postoperative pain associated with thoracotomy, a surgical procedure that can impact respiratory function and the patient's subsequent recovery. Epidural analgesia is the gold standard. When epidural catheter placement is not feasible, erector spinae plane block is a safe alternative. The ultrasound target is easily visualized, and the injection site is far from the neuraxis, pleura, and major vascular structures. Consequently, this block has been incorporated into standard clinical practice as a treatment option for patients with complex cases or as an alternative approach when epidural catheter placement is not feasible. The primary objective of this study is to assess the effectiveness of postoperative analgesia in patients undergoing elective thoracic surgery.

Study Population Design A prospective observational follow-up study will be conducted. ASA I-III patients undergoing scheduled thoracic surgery between November 1 and December 31, 2025, will be included. Their analgesic management will be based on standard clinical practice.

详细描述

The gold standard for managing pain after thoracic surgery is the administration of local anesthetics, with or without opioids, through a catheter placed in the epidural space during the 48-hour postoperative period. However, there are instances in which the placement of this catheter is contraindicated (due to patient refusal, coagulation disorders, spinal pathology, etc.) or in which the risk-benefit assessment necessitates the consideration of alternatives (it may lead to hypotension or bradycardia that compromises patients with cardiovascular disease, urinary retention, nerve injury, or spinal hematoma). This has prompted anesthesiologists to explore alternative options, including paravertebral block, which has shown promising results. However, it is important to note that paravertebral block is not entirely risk-free and has contraindications similar to those of epidural analgesia. When epidural catheter placement is not feasible, erector spinae plane block is a safe alternative. The ultrasound target is easily visualized, and the injection site is far from the neuraxis, pleura, and major vascular structures. Consequently, this block has been incorporated into standard clinical practice as a treatment option for patients with complex cases or as an alternative approach when epidural catheter placement is not feasible. The primary objective of this study is to assess the effectiveness of postoperative analgesia in patients undergoing elective thoracic surgery.

Design and Study Population A prospective observational cohort study will be conducted. Patients will be followed from the day of hospital admission (usually 24 hours before surgery, when informed consent will be requested) until hospital discharge.

The management of perioperative analgesia will adhere to standard clinical protocols, following a comprehensive evaluation by the anesthesiologist responsible for intraoperative anesthesia management.

Patients with ASA I-III classification who have scheduled thoracic surgery at the Doctor Negrín University Hospital of Gran Canaria between November 1 and December 31, 2025, will be included in the study. It is estimated that 80 patients will be included in this prospective, observational study.

On the day of the procedure, analgesic management will be administered according to the standard clinical practice of the anesthesiologist responsible for the patient's clinical management. The anesthesiologist will be unaware that the patient's perioperative analgesic management will be evaluated by this study. For all patients undergoing a regional procedure (epidural catheter or erector spinae plane block), standard aseptic measures will be followed during the procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing thoracic surgery between July 1 and October 31,
  • ASA I-III.
  • Signed informed consent

排除标准

  • ASA IV-V.
  • Chronic opioid treatment or treatment in the Chronic Pain Unit.
  • Intravenous drug abuse.
  • Local anesthetic allergy.
  • Language barrier, cognitive impairment, or inability to participate in clinical assessment during the study.
  • BMI <18 or >35 kg/m2

研究组 & 干预措施

Epidural analgesia

Patients whose analgesic management will be achieved through an epidural catheter.

干预措施: Postoperative pain through Visual analogue scale (Diagnostic Test)

Epidural analgesia

Patients whose analgesic management will be achieved through an epidural catheter.

干预措施: Postoperative complications (Diagnostic Test)

Erector spinae plane block

Patients whose analgesic management will be achieved through an erector spinae plane block

干预措施: Postoperative pain through Visual analogue scale (Diagnostic Test)

Erector spinae plane block

Patients whose analgesic management will be achieved through an erector spinae plane block

干预措施: Postoperative complications (Diagnostic Test)

结局指标

主要结局

Postoperative pain

时间窗: 24 postoperative hours

To evaluate the postoperative analgesic effect in patients undergoing elective thoracic surgery according to the Visual Analogue Scale, from 0 to 10.

次要结局

  • Postoperative analgesics consumption(24 postoperative hours.)
  • Postoperative complications(First postoperative week.)

研究者

发起方
Hospital Universitario de Gran Canaria Doctor Negrín
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ángel Becerra-Bolaños, MD PhD

Principal investigator

Hospital Universitario de Gran Canaria Doctor Negrín

研究点 (1)

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