- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07579975
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Berivan Bedir Sert, Medical doctor
- Numer telefonu: +905530884221
- E-mail: berivan34113@hotmail.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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." |
|
Eksperymentalny: 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." |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Time to first rescue analgesic requirement.
Ramy czasowe: 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.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative Pain Intensity
Ramy czasowe: 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
Ramy czasowe: 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.
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SBUGaziYasargilTRH2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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