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临床试验/CTRI/2025/08/093567
CTRI/2025/08/093567尚未招募2 期

Comparison of incidence of hemidiaphragmatic paresis in conventional volume with low volume Superior Trunk block in patients undergoing arthroscopic shoulder surgery

Vardhman Mahavir Medical College and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
using ultrasound.

研究概览

简要总结

This prospective randomized study compares the incidence of hemidiaphragmatic paresis and analgesic efficacy between low volume 4 mL and conventional volume 10 mL of 0.5 percent ropivacaine in ultrasound guided superior trunk block for arthroscopic shoulder surgery. Arthroscopic Bankart repair is associated with significant postoperative pain, and while interscalene brachial plexus block is effective, it frequently causes ipsilateral hemidiaphragmatic paresis, limiting use in patients with respiratory compromise. Superior trunk block targets C5 and C6 nerve roots to provide effective analgesia with potentially less phrenic nerve involvement, but the optimal local anesthetic volume is unclear. Seventy ASA I to II patients aged 18 to 65 years will be allocated to two groups receiving either 4 mL or 10 mL ropivacaine. Primary outcome is the incidence of hemidiaphragmatic paresis assessed by ultrasound diaphragmatic excursion. Secondary outcomes include pulmonary function tests, numeric rating scale pain scores, intraoperative fentanyl use, time to first rescue analgesia, postoperative tramadol use, and patient satisfaction. The study aims to determine the smallest effective volume that provides adequate analgesia while preserving respiratory function.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients (18-65 years) of American Society of Anesthesiologists (ASA) physical status I or II scheduled to undergo arthroscopic shoulder surgery.

排除标准

  • Patients with known case of coagulopathies or on anticoagulant therapy.
  • Infection at the proposed site of the block.
  • Known allergies to effect of local anesthetics.
  • Preexisting Neurological deficit in upper limbs.
  • Preexisting lung diseases or hemidiaphragmatic dysfunction.
  • Arthroscopic Rotator cuff repair.

结局指标

主要结局

using ultrasound.

时间窗: Pre op, 30 mins post block ,1hr Post Op

To compare the incidence of hemidiaphragmatic paresis after conventional

时间窗: Pre op, 30 mins post block ,1hr Post Op

volume with low volume Superior Trunk block in patients undergoing

时间窗: Pre op, 30 mins post block ,1hr Post Op

arthroscopic shoulder surgery as determined by diaphragmatic excursion

时间窗: Pre op, 30 mins post block ,1hr Post Op

次要结局

  • 1. To compare the PFTs ( Pulmonary Function Tests) after conventional(volume with low volume Superior Trunk block in patients undergoing)

研究者

发起方
Vardhman Mahavir Medical College and Safdarjung Hospital
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sankarshan M

Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar west, New Delhi - 110029

研究点 (1)

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