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临床试验/CTRI/2025/05/086831
CTRI/2025/05/086831尚未招募不适用

Serratus Plane Block Versus Local Anesthesia Infiltration in Patients Undergoing Intercostal Drain Insertion: A Randomized Controlled Trial

AIIMS Rishikesh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Patients will be asked to score their average pain on a Numeric Pain Rating Scale 10 mm from 0-10 mm where 0 suggests no pain and 10 suggests extreme pain at 4th hr.

研究概览

简要总结

A life-saving technique known as chest tube thoracostomy (CTT) facilitates lung re expansion, avoids tension pneumothorax, aids in the healing process following surgery, and relieves symptoms in some types of cancer(1,2).Pneumothorax, hemothorax, chylothorax, empyema, penetrating or severe blunt chest trauma, symptomatic pleural effusion, and chemical pleurodesis for benign and malignant disorders are among the circumstances for which CTT is indicated(3,4,5).But CTT is an extremely painful technique, with over 50% of patients reporting significant pain during or following the surgery(6).The location of the surgical incision, injury to the intercostal nerve, the pleural incision, or the presence of the drainage tubes and the irritation they cause afterwards can all cause pain.

TT is inserted following a regional anesthetic approach. Epidural, paravertebral, muscular plain, intraspinal, intercostal nerve blockage (ICNB), cryo analgaesia, and local administration of anesthetic agents are of presented regional anesthesia for TT insertion .Of these local infiltration anesthesia (LIA) is typically used, either with or without conscious sedation(7,8,9).Although local infiltration is normally safe, its effectiveness is short-lived(10)

A new method to manage patients undergoing CTT’s pain both during and after surgery is fascial plane block (also known as serratus anterior plane block [SPB]). In addition to being useful for treating rib fracture pain and situations requiring the insertion of a chest tube due to anterior and lateral chest wall injuries, SPB was originally developed to give analgesia during breast surgery .It has been demonstrated that SPB is a rather long-lasting localized anesthetic, which enhances incentive spirometry volumes and pain scores(11,12).

While most of the studies are done in a controlled settings like operation theater  this study will compare the SPB and LIA for post procedural analgesia in emergency department where pain management become a key role in managing these patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All patients who are 18 yrs or more who gives consent and having indication for an intercostal drainage insertion.

排除标准

  • Patients who are in altered mental status Patients having history of local anesthetic allergy Patients with infection at the insertion site Patients with deranged bleeding parameters Patients those who need emergency inter costal drainage tube insertion like tension pneumothorax and patients in severe Respiratory distress.

结局指标

主要结局

Patients will be asked to score their average pain on a Numeric Pain Rating Scale 10 mm from 0-10 mm where 0 suggests no pain and 10 suggests extreme pain at 4th hr.

时间窗: 4th hr

次要结局

  • 1. NRS score

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sarath S Nair

AIIMS Rishikesh

研究点 (1)

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