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临床试验/NCT06695624
NCT06695624尚未招募不适用

Investigation of the Effectiveness of Bilateral Endoscopic Sphenopalatine Ganglion Block in Management of Postoperative Pain After Septoplasty

Umraniye Education and Research Hospital0 个研究点目标入组 50 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
total amount of tramadol consumption

研究概览

简要总结

The aim of this clinical study will investigate the efficacy of sphenopalatine ganglion block in the treatment of postoperative pain.it will also be learnt whether it reduces the consumption of analgesics in postoperative pain.The main questions it aims to answer are:

Will the participants' need for painkillers decrease after the operation? Can sphenopalatine ganglion block be used for postoperative pain after septoplasty? The researchers will compare 2 groups with and without sphenopalatine ganglion block to see the effectiveness of sphenopalatine ganglion block.

Participants will:

Read the information Participants have been given about the sphenopalatine ganglion block.

In case of any side effects, please contact participant's doctor.

详细描述

This randomised controlled study will be conducted in Umraniye Training and Research Hospital operating room between November 2024 and January 2025 after obtaining ethics committee and patient consent. Each patient will be informed about the procedures to be performed during anaesthesia and surgery and signed informed consent will be obtained before the procedure. Patients will undergo septoplasty by the same otolaryngology team.

A total of 50 participants (25 envelopes each with Group 1 and Group 2 written inside) will be kept closed for the patients participating in the study. Upon the patient's fulfilment of the conditions suitable for the study, it will be randomly determined which group he/she will be included in. Thanks to this randomisation, conscious or unconscious manipulations in the selection of patients to the study group will be prevented.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants who will undergo septoplasty
  • 18 to 50 years old
  • ASA score 1 or 2

排除标准

  • Under 18 or over 50 years of age
  • ASA score III and above patient group
  • The patient is allergic to any of the drugs used
  • The patient has a contraindication to any of the drugs used
  • Use of anticoagulant medication
  • Failure of the patient to give consent
  • Being pregnant
  • Those with GCS retardation such as dementia, mental retardation
  • Those with diagnosed headache

结局指标

主要结局

total amount of tramadol consumption

时间窗: 24 hours

Total tramadol consumption will be recorded in the postoperative period by fitting participants with a patient-controlled analgesia device.

visual analogue scale

时间窗: 24 hours

Zero is equivalent to no pain and 10 indicates the worst possible pain.

次要结局

未报告次要终点

研究者

发起方
Umraniye Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Senay Goksu

specialist doctor

Umraniye Education and Research Hospital

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