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临床试验/CTRI/2019/09/021335
CTRI/2019/09/021335招募中不适用

Prospective observational study of thyroidectomy under USG guided bilateral superficial cervical plexus block

sanjay gandhi post graduate institute of medical sciences lucknow1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年1月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
evaluation of anesthetic efficacy of US guided cervical plexus block block for thyroidectomy

研究概览

简要总结

Traditionally general anesthesia is used for head and neck surgeries, including thyroidectomy /hemithyroidectomy/parathyroidectomy. However nowadays there is resurgence of regional anesthesia in form of superficial cervical plexus block( SCPB).

It has various advantage over GA in form of no cardiovascular depression ,lesser post op depression, & sedation ,less PONV, no respiratory complications, no interference with bowel function, early recovery and discharge,decreased cost of treatment etc.Traditionally this block is given by landmark technique which has its own limitation and complication in form of injury to vascular structures ,intraneural injection phrenic nerve paralysis etc.these complications can be minimised by giving the block under guidance of ultrasound.

Our primary objective will be evaluation of anesthetic efficacy of US guided cervical plexus block for thyroidectomy/parathyroidectomy. Secondary  objective will be intra op and post op analgesic requirement, patient & surgeon satisfaction score, block related complications, & hospital stay duration.

It will be a prospective observational study over a period of next 1 year.Standard ASA monitoring will be done.Bilateral superficial cervical plexus block will be given with 10  ml of bupivacaine 0.25 % with 22 G 2.5 inch needle.Effect of block will be assessed after 5 mins by pin prick test and reassessed again. After successful block surgeon will start surgery.In case of failed block patient will be given GA. For pain intraop  we will be using fentanyl. In post op we will be using paracetamol and  tramadol for rescue analgesia. Amount of Analgesic requirement will be noted.Post operative pain will be assessed on VAS scale at 0, 6 12 24  hours.Surgeon and patient satisfaction score will be asssessed alongwith duration of hospital stay and complications.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • 1.ASA 1 & 2 patients 2.Age 18-65 years (male &female ) 3.Small goitre (upto 4x4cm).

排除标准

  • 1.Patient Refusal 2.ASA 3 & 4 patients 3.Not cooperative and not able to understand instructions,communication barrier (dementia, language barrier, mental retardation) 4.Allergy to LA 5.Proven compromise in IDL in Vocal cords 6.Obese
  • H/o OSA, dyspnoea, tracheal deviation/ compression on neck X-ray 8.Recurrent goitre 9.Renal dysfunction.

结局指标

主要结局

evaluation of anesthetic efficacy of US guided cervical plexus block block for thyroidectomy

时间窗: every 5 minutes for first half hour and then every 15 minutes till end of surgery

次要结局

  • intra op and post op analgesic requirement(0 6 12 24 hrs after surgery)
  • block related complications(0 6 12 24 hrs after surgery)
  • patient satisfaction score(24 hours after surgery)
  • surgeon satisfaction score(24 hours after surgery)
  • hospital stay duration(once at the time of discharge)

研究者

发起方
sanjay gandhi post graduate institute of medical sciences lucknow
申办方类型
Government medical college

研究点 (1)

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