The Effect of Different Volumes of Ilioinguinal-Iliohypogastric Nerve Block on Postoperative Analgesia in Inguinal Hernia Surgery
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.
調査の概要
状態
詳細な説明
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).
Sensory block success is confirmed via pin-prick and cold tests 20-30 minutes after the procedure. Spinal anesthesia is subsequently performed at the L3-L4 level using 15 mg of 0.5% hyperbaric bupivacaine.
Outcome Measures and Follow-up Following surgery, patients are monitored in the Post-Anesthesia Care Unit (PACU) and transferred to the ward once they meet standard discharge criteria (Bromage score ≤2, Aldrete score ≥9).
Primary Outcome: Time to first analgesic requirement, defined as the duration from the block administration until the patient reports a Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) score of ≥4.
Secondary Outcomes: * Static and dynamic VAS/NRS scores at 0, 2, 6, 12, and 24 hours postoperatively.
Total 24-hour tramadol consumption (100 mg IV tramadol is administered as rescue analgesia for pain scores ≥4).
Incidence of postoperative complications (nausea, vomiting, urinary retention, hematoma, pruritus).
Time to first mobilization and patient/surgeon satisfaction.
Assessment of chronic postoperative pain at 3 and 6 months through outpatient follow-ups or telephone interviews.
Statistical Analysis Statistical analysis will be performed using SPSS version 26.0.
Descriptive data will be presented as mean, standard deviation, median, minimum, maximum, frequency, and percentage.
Normality will be assessed using skewness and kurtosis.
Between-group comparisons will be performed using independent samples t-test or Mann-Whitney U test.
Repeated measures ANOVA with Bonferroni post hoc test will be used for within-group comparisons over time.
Categorical variables will be analyzed using Chi-square test.
A p-value ≤ 0.05 will be considered statistically significant.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Berivan Bedir Sert, Medical doctor
- 電話番号:+905530884221
- メール:berivan34113@hotmail.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Grup I: Low Volume Group(10 mL)
Patients in this group will receive a 10 mL volume of 0.375% bupivacaine(37.5 mg) for the ultrasound-guided ilioinguinal-iliohypogastric block.
|
"Participants are randomized into two intervention groups to receive ultrasound-guided ilioinguinal-iliohypogastric nerve blocks with a fixed total dose of 37.5 mg bupivacaine. Group 1 (Low Volume): Receives 10 mL of 0.375% bupivacaine. Group 2 (High Volume): Receives 20 mL of 0.1875% bupivacaine. The procedure is performed using a high-frequency linear ultrasound probe. After the identification of the ilioinguinal and iliohypogastric nerves between the internal oblique and transversus abdominis muscles, the specified volume of local anesthetic is injected. All patients undergo the same surgical procedure (unilateral inguinal hernia repair) under spinal anesthesia. The primary focus is to evaluate the impact of local anesthetic volume on the duration and quality of postoperative analgesia." |
|
実験的:Grup II: Hıgh Volume Group(20 mL)
Patients in this group will receive a 20 mL volume of 0.1875% bupivacaine(37.5 mg) for the ultrasound-guided ilioinguinal-iliohypogastric block.
|
"Participants are randomized into two intervention groups to receive ultrasound-guided ilioinguinal-iliohypogastric nerve blocks with a fixed total dose of 37.5 mg bupivacaine. Group 1 (Low Volume): Receives 10 mL of 0.375% bupivacaine. Group 2 (High Volume): Receives 20 mL of 0.1875% bupivacaine. The procedure is performed using a high-frequency linear ultrasound probe. After the identification of the ilioinguinal and iliohypogastric nerves between the internal oblique and transversus abdominis muscles, the specified volume of local anesthetic is injected. All patients undergo the same surgical procedure (unilateral inguinal hernia repair) under spinal anesthesia. The primary focus is to evaluate the impact of local anesthetic volume on the duration and quality of postoperative analgesia." |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to first rescue analgesic requirement.
時間枠:Up to 24 hours postoperatively.
|
The time elapsed (measured in hours) from the completion of the ilioinguinal-iliohypogastric nerve block until the patient first requests or requires supplemental (rescue) analgesic medication due to a Visual Analog Scale (VAS) score of $\ge 4$.
This reflects the effective duration of the sensory block provided by the local anesthetic.
|
Up to 24 hours postoperatively.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Pain Intensity
時間枠:Up to 24 hours postoperatively
|
Pain intensity will be assessed using the Visual Analog Scale (VAS) at rest and during movement.
The scale ranges from 0 (no pain) to 10 (the worst imaginable pain)
|
Up to 24 hours postoperatively
|
|
Total Analgesic Consumption
時間枠:Up to 24 hours postoperatively.
|
The total cumulative dose of supplemental rescue analgesic medication (such as paracetamol or tramadol) consumed by the patient, measured in milligrams.
This measures the opioid-spar
|
Up to 24 hours postoperatively.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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最終確認日
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本研究に関する用語
その他の研究ID番号
- SBUGaziYasargilTRH2026
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医薬品およびデバイス情報、研究文書
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