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临床试验/CTRI/2025/09/095447
CTRI/2025/09/095447尚未招募4 期

A Randomized Double-Blind Clinical Trial to Compare the Effectiveness of Intranasal and Transoral Approaches of Sphenopalatine Ganglion Block for Postoperative Analgesia Following Functional Endoscopic Sinus Surgery

Dr Yarapotini Sneha Chowdary1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月7日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
compare the effectiveness of intranasal and transoral SPGB in reducing postoperative pain after functional endoscopic sinus surgery using VAS Score

研究概览

简要总结

All the patients will recieve standard General anesthesia

Participants will be randomly assigned to Group I intranasal or Group T transoral using a computer-generated block randomization

Allocation will be concealed via sequentially numbered, opaque, sealed envelopes prepared by an independent researcher

Transoral Approach - A 24G bent needle is inserted near the second molar, 1.5 to 2 ml of local anesthetic is injected and repeated on the opposite side

Intranasal Approach - Cotton pledgets soaked in 2 ml of local anesthetic are inserted along the superior border of middle terminate to reach posterior nasopharyngeal wall where SPG lies. Left for 5 to 10 min for anesthetic absorption and then repeated on the opposite side

Following a 10 min wait post block, conventional septoplasty will be performed

After extubation, patient will be assessed by a blinded observer for post operative pain using a VAS at intervals 0 min, 30 min, 1 hr, 2 hr, 4 hr and 6 hr.

If VAS score is greater than 4, rescue analgesia with IV diclofenac 75 mg will be given

Time to 1st rescue analgesia and total post operative analgesia consumption will be recorded.

Post operative complications like nausea, vomiting, headache, visual disturbances will be monitored for 24 hr post procedure

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • American Society of Anaesthesiologists Physical Status I and II.

排除标准

  • Localized infection at the site of SPG block application.
  • Hypersensitivity to local anesthetics.
  • Patients with chronic pain or long-term opioid use might confound pain assessment.
  • Coagulopathies or on-going anticoagulant or antiplatelet therapy Pregnant or breastfeeding patients Patients with altered mental status or cognitive impairments Patients with chronic liver/kidney diseases.

结局指标

主要结局

compare the effectiveness of intranasal and transoral SPGB in reducing postoperative pain after functional endoscopic sinus surgery using VAS Score

时间窗: 6 hours post surgery

次要结局

  • complications associated with intranasal or transoral approaches.

研究者

发起方
Dr Yarapotini Sneha Chowdary
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Yarapotini Sneha Chowdary

Kasturba Medical College; Manipal

研究点 (1)

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