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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grup I: Low Volume Group(10 mL) | Experimental | Patients in this group will receive a 10 mL volume of 0.375% bupivacaine(37.5 mg) for the ultrasound-guided ilioinguinal-iliohypogastric block. |
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| Grup II: Hıgh Volume Group(20 mL) | Experimental | Patients in this group will receive a 20 mL volume of 0.1875% bupivacaine(37.5 mg) for the ultrasound-guided ilioinguinal-iliohypogastric block. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine (Ilioinguinal-iliohypogastric nerve block) | Drug | "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." |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first rescue analgesic requirement. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Intensity | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Berivan Bedir Sert, Medical doctor | Contact | +905530884221 | berivan34113@hotmail.com |
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"Individual participant data will not be shared to protect patient confidentiality and ensure compliance with local data protection regulations. The study protocols and results will be made available through publication, but the raw data set is restricted to the primary investigators to maintain the integrity of the institutional data policy."
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"This is a prospective, randomized, double-blind, parallel-group controlled trial. Patients are allocated into two groups using a 1:1 ratio via a computer-generated randomization sequence. Group 1 receives a low-volume/high-concentration local anesthetic (10 mL), while Group 2 receives a high-volume/low-concentration local anesthetic (20 mL), keeping the total dose of bupivacaine constant at 37.5 mg. The primary objective is to compare the duration of postoperative analgesia between the two different volume strategies in ultrasound-guided ilioinguinal-iliohypogastric nerve blocks."
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"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."
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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. |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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