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临床试验/NCT07184463
NCT07184463招募中不适用

Chronic Pain After Thoracic Surgery: Towards a New Standard? A Comparative Prospective Study of Pain Reduction After Pulmonary Resection by RATS-TT, RATS-OTC, and Hybrid RATS.

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年12月5日最近更新:
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
120
试验地点
1
主要终点
Presence of persistent postoperative pain

研究概览

简要总结

Pulmonary resections are key in treating lung neoplasms, with techniques adapted to tumor size and location. Minimally invasive approaches like VATS have replaced open thoracotomy, but intercostal trocar placement can lead to nerve injury and chronic pain.

Robotic-assisted thoracic surgery (RATS) is usually done via a transthoracic (RATS-TT) approach using intercostal trocars. A newer "out of cage" method (RATS-OTC), using subcostal or subxiphoid ports, avoids intercostal access, potentially reducing nerve damage. A French study showed less opioid use and acute pain with RATS-OTC, but chronic pain outcomes are still unknown.

At CHUM, a hybrid RATS technique (RATS-TTH) is also used-intercostal for instruments, but with out-of-cage specimen extraction-to limit intercostal trauma.

详细描述

Pulmonary resections play a crucial role in the treatment of lung neoplasms, with procedures tailored to the size and location of the tumors. The minimally invasive approach, particularly via video-assisted thoracoscopic surgery (VATS), has replaced traditional thoracotomy by allowing access to the thoracic cavity through surgical trocars inserted between the ribs. However, these trocars, placed near the intercostal nerves, can cause nerve injury and chronic pain.

Robotic-assisted thoracic surgery (RATS) is typically performed via a transthoracic approach (RATS-TT), using intercostal trocars similar to those in VATS. Recently, a robotic approach known as "out of cage" (RATS-OTC) has been described, which involves the use of subcostal or subxiphoid trocar insertion. This method avoids the passage of instruments through the intercostal space, thus theoretically eliminating the risk of intercostal nerve injury. Compared to the transthoracic approach, a French team reported a reduction in opioid use and decreased intensity of acute postoperative pain with the RATS-OTC approach. However, due to the novelty of this technique, chronic pain outcomes have yet to be compared with those observed in RATS-TT or VATS.

At the CHUM, a modified transthoracic RATS technique-called the hybrid approach (RATS-TTH)-is also used. In this method, trocars are placed intercostally, but the extraction of large pulmonary specimens is performed through an out-of-cage route to minimize potential intercostal trauma related to specimen removal. Pain associated with this approach has also not been described in the literature.

Postoperative pain significantly affects recovery and long-term quality of life. Although the VATS approach reduces the severity of acute pain, chronic pain remains common and impactful. In fact, in the CRYO-VATS study conducted at CHUM between 2023 and 2025, the incidence of chronic pain following pulmonary resection via VATS (without cryoanalgesia) was 30% at 3 months and 17.5% at 6 months.

The aim of this study is to describe the incidence of chronic pain at 3 and 6 months for the three surgical approaches used at CHUM:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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 aged 18 years and older
  • American Society of Anesthesiologists (ASA) score 1-3

排除标准

  • Language barrier, psychiatric, physical or mental condition making pain assessment impossible despite prior education
  • Patient refusal to participate
  • Patients reoperated by VATS or thoracotomy in the postoperative period in the context of the occurrence of complications

研究组 & 干预措施

Pulmonary resections surgery with three surgical approaches:

RATS-OTC (no intercostal access)

RATS-TT (intercostal instruments and specimen)

RATS-TTH (intercostal instruments, out-of-cage specimen)

干预措施: Evaluation of chronic pain at 3 and 6 months after thoracic surgery (Other)

结局指标

主要结局

Presence of persistent postoperative pain

时间窗: 3 and 6 months after surgery

The presence of persistent postoperative pain, defined as ipsilateral chest pain (on the same side as the surgery) occurring at rest and/or with coughing on a daily basis. Assessed by a 'yes' or 'no' response when asked at 3 and 6 months postoperatively.

次要结局

  • Occurrence of a neuropathic pain component(3 and 6 months after surgery)
  • Impact of chronic pain on overall recovery(3 and 6 months after surgery)
  • Preoperative analgesic use(On the day of the surgery)
  • Overall recovery(3 and 6 months after surgery)
  • Residual pain intensity(3 and 6 months after surgery)
  • Total length of hospital stay(On the day patient is discharged from hospital, up to two weeks)
  • Total opioid consumption during hospitalization(On the day patient is discharged from hospital, for an average of 1-2 days)
  • Type of chronic analgesia(3 and 6 months after surgery)
  • Presence of dysesthesia(3 and 6 months after surgery)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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