跳至主要内容
临床试验/NCT07011069
NCT07011069已完成不适用

Comparison of the Efficacy of Rhomboid Intercostal and Subserratus Plane Block (RISS) Versus Erector Spinae Plane (ESP) Blocks in Video-Assisted Thoracoscopic Surgery (VATS) for Postoperative Pain Management and Respiratory Function

Bursa City Hospital2 个研究点 分布在 2 个国家目标入组 93 人开始时间: 2025年6月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
93
试验地点
2
主要终点
Incidence of chest tube-site somatic pain

研究概览

简要总结

To compare the rhomboid intercostal subserratus plane block with the erector spinae plane block regarding their analgesic efficacy and effects on respiratory function for patients undergoing video-assisted thoracoscopic surgery.

详细描述

Video-assisted thoracoscopic surgery (VATS) can be very painful and may lead to complications such as prolonged stays in intensive care, thromboembolic complications due to lack of early mobilization, chronic acute pain, and delirium if adequate analgesia is not provided. Therefore, using thoracic epidural, paravertebral, or regional blocks as part of multimodal analgesia is recommended to provide effective pain relief.

This study aims to compare the effects of the erector spinae plane block (ESP) and rhomboid intercostal subserratus plane block (RISS) on postoperative analgesia and the improvement of respiratory parameters in patients undergoing VATS. These two techniques may have different analgesic profiles with respect to somatic and visceral pain.

The primary objective is to evaluate the incidence of chest tube-site somatic pain at postoperative hour 2. Secondary objectives include the incidence of visceral pain, total analgesic consumption in the first 24 hours postoperatively, assessing resting and dynamic pain scores, triflow performance, complications, and length of hospital stay.

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
Triple (Participant, Care Provider, 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
否

入选标准

  • •Patients who will undergo VATS
  • •Who agrees to participate
  • •American Society of Anesthesiologists (ASA) physical status I, II, and III
  • •Elective surgery
  • •Age between 18 and 80 years

排除标准

  • •Local anesthetic allergy
  • •Who disagrees to participate
  • •ASA physical status IV and V
  • •Emergency surgery
  • •Hemorrhagic disease
  • •Thoracic vertebrae deformity
  • •Thoracic vertebrae surgery

研究组 & 干预措施

Patients who received ESP block

Active Comparator

Those who received the erector spinae plane block for postoperative pain management

干预措施: ESP block group (Procedure)

Patients who received RISS block

Active Comparator

Those who received the rhomboid intercostal subserratus plane block for postoperative pain management

干预措施: RISS block group (Procedure)

结局指标

主要结局

Incidence of chest tube-site somatic pain

时间窗: At postoperative hour 2

Proportion of participants with localized pain at the chest tube insertion site, elicited by palpation or chest tube manipulation. Somatic pain was recorded as present or absent.

Opioid consumption

时间窗: Postoperative first 24 hours.

Total opioid consumption within the first 24 hours in the postoperative period.

次要结局

  • Dynamic pain score(Postoperative first 24 hours.)
  • Opioid consumption(Postoperative first 24 hours.)
  • Complications(From block administration to hospital discharge.)
  • Hospital stay time(From surgery to hospital discharge.)
  • Incidence of visceral pain(At postoperative hour 2)
  • Resting pain score(Postoperative first 24 hours.)
  • Pulmonary functions(Postoperative first 24 hours.)
  • Complications(Through study completion, an average of 1 year)
  • Hospital stay time(Perioperatively)

研究者

发起方
Bursa City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Hande Gurbuz

Assoc. Prof., MD, PhD

Bursa City Hospital

研究点 (2)

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