跳至主要内容
临床试验/NCT06838793
NCT06838793招募中不适用

Quality of Recovery After Video-assisted Thoracoscopic Surgery: A Prospective, Randomised, Double-Blinded Trial Comparing Single and Three Level Intertransverse Process Block.

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年3月4日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Quality of recovery

研究概览

简要总结

This study aims to evaluate the quality of recovery after video-assisted thoracoscopic surgery (VATS) by comparing the efficacy of a single-level intertransverse process block (ITPB) against a three-level ITPB, with particular attention to the quality of recovery measured by the QoR15 score at 24 hours post-surgery.

详细描述

Video-assisted thoracoscopic surgeries (VATS) are currently the preferred technique for treating carcinoma lung. Despite being minimally invasive, VATS is associated with significant acute and chronic postoperative pain. Regional anesthetic techniques have the potential to block afferent nociception at the peripheral nerve level, the dorsal root ganglion (DRG), the thoracic sympathetic ganglion, or through a combination of these mechanisms. While the peripheral nerve block techniques such as the intercostal nerve block and serratus anterior plane block can provide analgesia for port related somatic pain, the visceral pain mediated via the thoracic sympathetic chain during VATS procedure are amenable only to epidural or paravertebral regional anaesthetic techniques. The thoracic paravertebral block (TPVB) provides ipsilateral, segmental, somatic, and sympathetic nerve blockade across multiple contiguous thoracic dermatomes and is currently the first choice for VATS. During a TPVB, the local anaesthetic (LA) is injected into the paravertebral space adjacent to the thoracic vertebra, near the intervertebral foramen.

Traditionally, TPVB is performed using either landmark or ultrasound guidance, with the LA deposited anterior to the superior costotransverse ligament (SCTL). This typically involves the block needle piercing the SCTL to reach the wedge-shaped TPVB space. While Thoracic Paravertebral Block (TPVB) is generally regarded as safe, the proximity of the needle tip to the pleura during injection poses a heightened risk of pleural puncture and pneumothorax, especially when administered by less experienced physicians. Consequently, the Erector Spinae Plane Block (ESPB) is gaining popularity as an alternative. However, it is important to note that ESPB also has its own limitations.

Recent advancements have redefined thoracic paravertebral anatomy, identifying a fat-filled retro-SCTL space located behind the SCTL. This space is farther from the pleura but remains in close proximity to anterior neural targets such as the thoracic spinal nerve, the DRG and thoracic sympathetic ganglion. It is hypothesised that an LA injection into the retro-SCTL space-referred to as the Intertransverse Process Block (ITPB) at the medial retro SCTL space-could produce a rapid onset of ipsilateral and/or bilateral segmental somatic and sympathetic nerve blockade of the thoracic dermatomes without the need to pierce the SCTL, thereby reducing the risk of pleural puncture and pneumothorax. Preliminary investigations on the ITPB for VATS is promising, however, there is a paucity of data on the effect of the number of injections following an ultrasound-guided (USG) ITPB on the analgesic efficacy, which this study aims to evaluate.

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)

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

入选标准

  • ASA I-III patients
  • 18 to 80 years of age
  • Patients with primary carcinoma lung scheduled for resection under VATS procedure

排除标准

  • Patient refusal
  • Local skin infection at the area of injection
  • Coagulopathy
  • History of allergy to local anaesthetics

结局指标

主要结局

Quality of recovery

时间窗: At 24 hours post surgery

Comparing the quality of recovery 15 (QoR15) score at 24 hours between the study groups. QoR15: a minimum score of 0 (poor recovery) and a maximum score of 150 (excellent recovery)

次要结局

  • Area under the curve for pain at rest and movement (deep breathing)(Over the first 24 hours after surgery)
  • Number of hypoesthetic and anaesthetic dermatomes(At 15 and 30 minutes after block completion)
  • Rescue fentanyl and phenylephrine administration(Intraoperative)
  • Postoperative morphine, tramadol and ondansetron consumption(At 24 and 48 hour post sugery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof Manoj K Karmakar

Professor

Chinese University of Hong Kong

研究点 (1)

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