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临床试验/CTRI/2020/03/024236
CTRI/2020/03/024236尚未招募1 期

Analgesic efficacy of Ultrasound guided Erector Spinae Plane Block or Ilioinguinal/ Iliohypogastric nerve block in patients undergoing unilateral inguinal hernia meshplasty - A Randomised Study

Government Medical College and Hospital Chandigarh1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年1月4日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To evaluate the comparative reduction in pain intensity by use of linear visual analogue scale (VAS) in post-operative period in patients receiving ultrasound guided erector spinae block or Ilioinguinal/iliohypogastric nerve block following unilateral open mesh hernioplasty

研究概览

简要总结

Erector Spinae Plane (ESP) block is a more recent regional anaesthetic technique use to provide post-operative pain relief, both acute and chronic, for various surgical procedures. As this is a relatively newer block, its beneficial prospects in a variety of procedures are yet to be explored with many trials and studies ongoing

Presently, the literature available on ESP block is deficient in describing its utility in inguinal hernia patients, especially adults. There is limited evidence available on the advantages of ESP block, but we hypothesise that based on the simplicity of identification and administration, lower risk of adverse events as tissue plane is away from major neurovascular bundles and pleura, it has significant advantages over other methods currently employed for pain management in inguinal hernia surgeries. Also IIN/IHN block has been found to provide adequate analgesia after hernioplasty. Although ultrasound guided interfascial blocks have been utilized in hernioplasty for providing adequate post-operative analgesia, however limited literature is available in comparing the analgesic efficacy between ESP block and IIN/IHN block in patients undergoing unilateral inguinal hernia repair. We hypothesise that ESP block or IIN/IHN block may be equivalent or either of the block may prove to be more efficacious in providing adequate and effective post-operative analgesia in patients undergoing unilateral mesh hernioplasty under subarachnoid block. Hence,  the present study is being undertaken to compare the efficacy of Ultrasound guided ESP block with ultrasound-guided Ilioinguinal/Iliohypogastric nerve block for post-operative analgesia in patients scheduled to undergo elective unilateral inguinal hernia meshplasty.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator 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

  • Age group 18 to 65 years Patient belonging to American Society of Anaesthesiology (ASA) physical status 1 and 2 Elective surgery for unilateral inguinal hernia (open meshplasty).

排除标准

  • Patient refusal Recurrent hernia Inguino-Scrotal or Sliding hernia Allergy to local anaesthetics Infection at block injection site Opioid dependence Chronic Pain Coagulopathy Patient with severe pulmonary disease, cardiac disease Pre-existing neurological deficits Dementia Pregnancy Contraindication to Subarachnoid Block Inability to comprehend pain scale or use PCA device.

结局指标

主要结局

To evaluate the comparative reduction in pain intensity by use of linear visual analogue scale (VAS) in post-operative period in patients receiving ultrasound guided erector spinae block or Ilioinguinal/iliohypogastric nerve block following unilateral open mesh hernioplasty

时间窗: 30min, 1hr, 4hr, 8hr, 12hr, 24hr

次要结局

  • To calculate and compare the total dose of antiemetics over 24 hours in both the groups.
  • Time to first rescue analgesic
  • To calculate and compare the cumulative morphine consumption over 24 hours in post- operative period in both the groups.
  • To note any side effects pertaining to the procedure or the drugs used in the present study.

研究者

发起方
Government Medical College and Hospital Chandigarh
申办方类型
Government medical college

研究点 (1)

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