Inguinal Hernia Postoperative Pain Acute PainNCT07579975
The Effect of Different Volumes of Ilioinguinal-Iliohypogastric Nerve Block on Postoperative Analgesia in Inguinal Hernia Surgery
A study testing Bupivacaine (Ilioinguinal-iliohypogastric nerve block) in people with Inguinal Hernia Postoperative Pain Acute Pain, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inguinal Hernia Postoperative Pain Acute Pain
- What is being tested?
- Bupivacaine (Ilioinguinal-iliohypogastric nerve block)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2026to 14 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Being tested
- Bupivacaine (Ilioinguinal-iliohypogastric nerve block)
- Keywords
- Unilateral inguinal hernia Ilioinguinal-iliohypogastric nerve block Postoperative analgesia Local anesthetic volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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."
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bupivacaine (Ilioinguinal-iliohypogastric nerve block) |
| 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. Receives: Drug: Bupivacaine (Ilioinguinal-iliohypogastric nerve block) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 hours postoperatively.
Secondary outcomes (2)
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)
Measured: Up to 24 hours postoperatively
Total Analgesic Consumption
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
Measured: Up to 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start14 Apr 2026 (estimated)
- Primary completion14 May 2026 (estimated)
- Study completion14 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia Postoperative Pain Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- "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."
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BERİVAN BEDİR SERT, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579975
- Sponsor's protocol ID
- SBUGaziYasargilTRH2026
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "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."
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Volumes of Ilioinguinal-Iliohypogastric Nerve Block on Postoperative Analgesia in Inguinal Hernia Surgery
- ClinicalTrials.gov ID
- NCT07579975
- Acronym / sponsor ID
- SBUGaziYasargilTRH2026
- Keywords
- Unilateral inguinal hernia Ilioinguinal-iliohypogastric nerve block Postoperative analgesia Local anesthetic volume
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 14 Apr 2026 (estimated)
- Primary completion
- 14 May 2026 (estimated)
- Study completion
- 14 Nov 2026 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- "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."
| Arm | Type | Receives |
|---|---|---|
| Grup I: Low Volume Group(10 mL) | Experimental | Drug: Bupivacaine (Ilioinguinal-iliohypogastric nerve block)Patients in this group will receive a 10 mL volume of 0.375% bupivacaine(37.5 mg) for the ultrasound-guided ilioinguinal-iliohypogastric block. |
| Grup II: Hıgh Volume Group(20 mL) | Experimental | Drug: Bupivacaine (Ilioinguinal-iliohypogastric nerve block)Patients in this group will receive a 20 mL volume of 0.1875% bupivacaine(37.5 mg) for the ultrasound-guided ilioinguinal-iliohypogastric block. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine (Ilioinguinal-iliohypogastric nerve 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." | Drug | Grup I: Low Volume Group(10 mL), Grup II: Hıgh Volume Group(20 mL) |
Primary outcome
Time to first rescue analgesic requirement.
Time frame: 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.
2 secondary outcomes
Postoperative Pain Intensity
Time frame: Up to 24 hours postoperatively
Total Analgesic Consumption
Time frame: Up to 24 hours postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No. "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."
Related trials for Inguinal Hernia Postoperative Pain Acute Pain
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Active, not recruiting
Comparing Two Nerve Block Methods for Pain Relief in Laparoscopic Hernia Surgery
MeSH C23.300.707.374.875, MeSH E01.370.388.250.520
Recruiting
Comparing the Postoperative Analgesic Efficacy of Anterior Iliac Block and Ilioinguinal-iliohypogastric Block in Inguinal Hernia Surgery
Acute Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine (Ilioinguinal-iliohypogastric nerve block) in people with Inguinal Hernia Postoperative Pain Acute Pain, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berivan Bedir Sert, Medical doctor (+905530884221, berivan34113@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first rescue analgesic requirement. (time frame: Up to 24 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.