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临床试验/NCT07579975
NCT07579975尚未招募不适用

The Effect of Different Volumes of Ilioinguinal-Iliohypogastric Nerve Block on Postoperative Analgesia in Inguinal Hernia Surgery

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital0 个研究点目标入组 70 人开始时间: 2026年4月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70

研究概览

简要总结

The primary objective of this study is to evaluate and compare the efficacy of different volumes of local anesthetics, administered at the same total dose, for ilioinguinal and iliohypogastric (II/IH) nerve blocks in patients undergoing unilateral inguinal hernia repair.

The investigators aim to determine whether varying the injectate volume-while keeping the total drug amount constant-influences the quality and duration of postoperative analgesia. By monitoring pain scores and opioid consumption, this research seeks to identify the optimal volume-to-dose ratio for enhancing patient recovery and pain management following inguinal surgery.

详细描述

Study Design and Patient Selection This study is designed as a prospective, randomized, controlled, single-center trial to evaluate the efficacy of different local anesthetic volumes in ilioinguinal-iliohypogastric (II-IH) nerve blocks. The study is conducted in accordance with the Declaration of Helsinki. Patients aged 18-75, with an ASA physical status of I-III, scheduled for unilateral open inguinal hernia repair under spinal anesthesia, are eligible for inclusion. Exclusion criteria include BMI >35 kg/m², pregnancy, emergency surgery, coagulopathy, infection at the injection site, known allergy to local anesthetics, chronic opioid use, and cognitive impairment.

Randomization and Blinding A total of 70 patients are randomly assigned to two equal groups (1:1 ratio) using a computer-generated sequence and the sealed envelope method. The study is assessor-blinded; while the anesthesiologist performing the nerve block is aware of the group allocation, the researchers responsible for postoperative pain assessment and the statisticians are blinded to the group assignments.

Interventional Procedure All patients receive standard monitoring and minimal sedation with 1 mg of IV midazolam. The II-IH nerve block is performed under ultrasound guidance (high-frequency linear probe) 30 minutes before spinal anesthesia using an in-plane technique. The needle is positioned between the internal oblique and transversus abdominis muscles, and the position is confirmed via hydrodissection.

Group 1 (Low Volume): Receives 10 mL of 0.375% bupivacaine (7.5 mL of 0.5% bupivacaine + 2.5 mL of saline).

Group 2 (High Volume): Receives 20 mL of 0.1875% bupivacaine (7.5 mL of 0.5% bupivacaine + 12.5 mL of saline).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

"A double-blind masking protocol will be implemented. The patients will be blinded to their group assignment (Participant masking). The physician performing the ultrasound-guided block will be aware of the volume administered due to the nature of the intervention. However, a separate investigator, who is blinded to the group allocations and volume administered, will perform all postoperative assessments, including pain scores (VAS) and analgesic consumption (Outcomes Assessor masking). Randomization codes will be kept in sealed, opaque envelopes and will only be opened by the performing anesthesiologist."

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18 and 75 years
  • American Society of Anesthesiologists (ASA) physical status I, II, or III
  • Diagnosis of unilateral inguinal hernia
  • Scheduled for elective open inguinal hernia repair under spinal anesthesia

排除标准

  • Age under 18 or over 75 years
  • ASA physical status IV or higher
  • Body mass index (BMI) greater than 35 kg/m²
  • Pregnancy or suspected pregnancy
  • Emergency surgery
  • Refusal to provide informed consent
  • Known or suspected coagulopathy
  • Local infection at the site of the nerve block
  • Known allergy to local anesthetics
  • History of chronic opioid use or substance abuse
  • Cognitive impairment or inability to cooperate with study procedures (e.g., inability to use the visual analog scale)

研究者

发起方
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

BERİVAN BEDİR SERT

Resident Physician in Anesthesilogy

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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