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临床试验/CTRI/2025/08/092813
CTRI/2025/08/092813尚未招募2/3 期

Efficacy Of Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block With And Without Subcostal Nerve Block For Post-operative Analgesia In Patients Undergoing Hernia Repair Surgery- A Double Blinded Randomised Control Study

Vinayaka Missions Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年8月26日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
-To compare the rescue analgesic requirement in the first 24 hours of post-operative period with and without Subcostal nerve block

研究概览

简要总结

**Summary:**This study investigates whether adding a subcostal nerve block to the commonly used ilioinguinal/iliohypogastric (II/IH) nerve block provides better post-operative pain relief for patients undergoing open inguinal hernia repair.

The research is conducted as a single-blinded randomized controlled trial at a tertiary care hospital involving 68 male patients (aged 18–65, ASA I–II, BMI less than 30).

Participants are randomly divided into:

  • Group A: Receives II/IH block with subcostal nerve block.
  • Group B: Receives II/IH block alone.

Aims & Objectives:

  • Primary Objective: Compare the need and timing of rescue pain medication within 24 hours post-surgery.
  • Secondary Objectives: Compare intra-operative pain control, length of hospital stay, and post-operative nausea/vomiting.

Methodology:

  • All nerve blocks are performed under ultrasound guidance.
  • Pain is assessed using the Visual Analogue Scale at 0, 4, and 24 hours post-op.
  • Data is analyzed statistically with significance set at p less than 0.05.

Significance:

  • This is the first RCT exploring whether adding a subcostal block improves analgesia in this context.
  • Aims to improve post-surgical comfort, reduce opioid use, shorten hospital stay, and contribute to enhanced recovery protocols.

Ethical Considerations:

  • Approved by Institutional Ethical Committee.
  • Informed consent to be obtained from all participants.

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
Male

入选标准

  • ASA physical status 1 and 2 patients posted for unilateral open inguinal hernia surgery 2) Body Mass Index (BMI) less than 30 kg per metre square.

排除标准

  • Known allergies to local anesthetics and analgesics 2) Coagulation disorders 3) Body Mass Index (BMI) more than 30 kg per metre square.

结局指标

主要结局

-To compare the rescue analgesic requirement in the first 24 hours of post-operative period with and without Subcostal nerve block

时间窗: 0, 4 hours, 6 hours, 12 hours, 24 hours

次要结局

  • -To compare the time until first analgesic requirement using Visual Analogue Scale(VAS) scores(0, 4 hours, 6 hours, 12 hours, 24 hours)

研究者

发起方
Vinayaka Missions Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Prasanna Vadhanan

Vinayaka Missions Medical College and Hospital, Karaikal

研究点 (1)

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