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临床试验/CTRI/2025/02/080921
CTRI/2025/02/080921尚未招募3 期

Ultrasound Guided Ilioinguinal-Iliohypogastric Nerve Block Versus Ultrasound Guided Transversus Abdominal Plane Block for Post-Operative Analgesia in Open Inguinal Hernia Repair: A Randomised Controlled Trial

NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年2月26日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
To compare Ultrasound Guided Ilioinguinal- Iliohypogastric nerve block versus Ultrasound Guided Transversus Abdominis Plane block for post-operative analgesia in open inguinal hernia repair in terms of:

研究概览

简要总结

Open Inguinal Hernia surgery is one of the most commonly performed procedures across the world and is associated with about 60 percent moderate to severe post operative pain.

 This acute postoperative pain without adequate analgesia may lead to persistent postsurgical pain. The incidence of chronic postsurgical pain varies according to surgeries and is 5 percent to 35 percent in hernia surgery.

  For management of pain, in post operative hernia repair, various treatment modalities have been advocated. Most of them have been proved inconsistent. Despite of providing good analgesia, Opioids and NSAIDs are associated with several undesirable side effects.

 The major goal in the management of post-operative pain is to use minimal dose of medications to decrease their side effects.

 Regional nerve block techniques offer a great degree of post-operative pain relief thus facilitating early ambulation and discharge.

 Transversus abdominis plane contains intercostal nerves (T7-T11), subcostal nerves(T12), iliohypogastric and ilioinguinal nerves(L1)

 Transversus abdominis plane block [TAP]  has been extensively used for post operative analgesia after inguinal hernia repair.TAP block being a compartment block provides analgesia to the parietal peritoneum and sensation to anterior and lateral abdominal wall in infra-umbilical surgeries block it requires larger volume.

 Ilioinguinal-iliohypogastric nerve block, blocks the branches of T12-L1 and provide effective analgesia in inguinal hernia surgeries.

 Local anaesthetic is deposited in the plane between the internal oblique and transverse abdominis muscle in both TAP and IIL/IH block, but at different points along the course of nerve , with local anaesthetic being administered closer to nerve in IIL/IH block.

 IIL/IH block being more precise requires lower volume of local anaesthetic and so lesser anaesthetic toxicity, complications and more simplicity and efficacy than TAP block to achieve similar analgesic effect.

 There are few studies comparing IIL/IH and TAP block for post oprerative analgesia for inguinal hernia repair but results are conflicting.

 Hence, we would like to propose a study for comparison of ultrasound guided IL/IH nerve block and ultrasound guided TAP block for open hernia repair for post operative analgesia.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
Male

入选标准

  • Patient undergoing unilateral inguinal hernia surgeries under subarachnoid block
  • American Society of Anaesthesiology (ASA) physical status I,II, III
  • BMI less than 30 Kg/m2.

排除标准

  • H/o allergy to local anaesthetics.
  • Infection around the block site.
  • Patient’s Refusal.
  • Coagulopathy.
  • Chronic opioid use.

结局指标

主要结局

To compare Ultrasound Guided Ilioinguinal- Iliohypogastric nerve block versus Ultrasound Guided Transversus Abdominis Plane block for post-operative analgesia in open inguinal hernia repair in terms of:

时间窗: Time of block will be taken as 0 hrs. | Patient will be analysed for the above points at 1, 2, 3, 4, 6, 8, 12, 24 hrs.

Numerical Rating Score for pain assessment

时间窗: Time of block will be taken as 0 hrs. | Patient will be analysed for the above points at 1, 2, 3, 4, 6, 8, 12, 24 hrs.

Time of first rescue analgesia

时间窗: Time of block will be taken as 0 hrs. | Patient will be analysed for the above points at 1, 2, 3, 4, 6, 8, 12, 24 hrs.

Total analgesic requirement in first 24 hrs.

时间窗: Time of block will be taken as 0 hrs. | Patient will be analysed for the above points at 1, 2, 3, 4, 6, 8, 12, 24 hrs.

次要结局

  • Comparison of the complications of Ultrasound Guided Ilioinguinal-Iliohypogastric nerve block and Transverse Abdominis Plane block for post operative analgesia in open inguinal hernia repair with respect to:

研究者

发起方
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Bhagyashri Nemade

NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital

研究点 (1)

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