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临床试验/CTRI/2026/02/103825
CTRI/2026/02/103825尚未招募4 期

Comparative Evaluation of efficacy of Ultrasound guided versus Landmark technique of Sphenopalatine ganglion nerve block in patients undergoing Functional Endoscopic Sinus Surgery: A Randomized, Open -label, Superiority Trial

AIIMS Nagpur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月27日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
AIIMS Nagpur
入组人数
60
试验地点
1

研究概览

简要总结

This prospective, randomized, single-blinded superiority trial will compare the efficacy of ultrasound-guided versus traditional trans-nasal sphenopalatine ganglion block (SPGB) in adult patients undergoing Functional Endoscopic Sinus Surgery (FESS) at AIIMS Nagpur. Postoperative pain and haemodynamic instability remain major concerns in FESS, and SPG block is an emerging technique to improve perioperative analgesia. While the trans-nasal method is simple but variable, ultrasound guidance may offer more accurate drug deposition with improved safety and efficacy.

A total of 60 patients, aged 18–50 years with ASA I–II status, will be randomly allocated into two equal groups: Group N (trans-nasal SPGB) and Group U (ultrasound-guided SPGB). All patients will undergo standardized general anaesthesia. Group N will receive a cotton-swab–based bupivacaine application, while Group U will receive a targeted injection under ultrasound visualization.

The primary outcome is intraoperative haemodynamic stability measured through heart rate and mean arterial pressure. Secondary outcomes include total intraoperative opioid requirement, need for dexmedetomidine for controlled hypotension, surgical field quality, block performance time, postoperative VAS scores, and complications within 24 hours.

Data will be analysed using appropriate parametric or non-parametric tests, with significance set at p<0.05. The study aims to generate evidence to guide optimal SPGB technique for improved perioperative outcomes in FESS.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 to 50 years
  • American Society of Anesthesiologists physical status I or II.

排除标准

  • Patients aged less than 18 years and more than 50yeras
  • Emergency surgeries
  • Patient not willing to participate.
  • Patients with infective pathologies eg mucormycosis.
  • Patients with cardiac disorders.
  • History of allergy to medications being used.

研究者

发起方
AIIMS Nagpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Ridhima Sharma

AIIMS Nagpur

研究点 (1)

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