Inguinal HerniaNCT06997536
Comparison of Postoperative Analgesic Efficacy of Ultrasound-Guided Ilioinguinal-Iliohypogastric Block, Transversus Abdominis Plane Block, and Quadratus Lumborum Block in Inguinal Hernia Surgery
A study testing Ilioinguinal/iliohypogastric Nerve Block, Transversus abdominis plane (TAP) block and Quadratus Lumborum Block (QLB) in people with Inguinal Hernia and Transversus Abdominis Plane (TAP) Block, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Inguinal hernia is a common condition, particularly among male patients, and represents one of the most frequent indications for lower abdominal surgeries. Postoperative acute pain and, more importantly, the progression of acute pain into chronic pain, remain significant challenges in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inguinal Hernia, Transversus Abdominis Plane (TAP) Block, Iliohypogastric/Ilioinguinal Nerve Block
- What is being tested?
- Ilioinguinal/iliohypogastric Nerve Block, Transversus abdominis plane (TAP) block and Quadratus Lumborum Block (QLB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jun 2022to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 classified as ASA I and II
- Patients aged 18 to 75 years
- Patients undergoing unilateral inguinal hernia surgery under spinal anesthesia
Who cannot join
- Patients with preoperative neurological sequelae
- Patients with a BMI >30
- Patients who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Ultrasound-Guided Ilioinguinal-Iliohypogastric Block, Transversus Abdominis Plane Block, and Quadratus Lumborum Block in Inguinal Hernia Surgery: A Prospective, Randomized Controlled Trial
Inguinal hernia is a common condition, particularly among male patients, and represents one of the most frequent indications for lower abdominal surgeries. Postoperative acute pain and, more importantly, the progression of acute pain into chronic pain, remain significant challenges in the postoperative period. Effective postoperative pain management is therefore crucial in inguinal hernia repair.
In addition to systemic analgesia, various regional anesthesia techniques are employed in this setting. In recent years, peripheral nerve blocks such as the ilioinguinal-iliohypogastric (IL/IH) block, transversus abdominis plane (TAP) block, and quadratus lumborum block (QLB) have gained popularity for postoperative analgesia. These techniques offer several advantages, including reduced opioid consumption and decreased need for additional analgesics, while also minimizing hemodynamic instability and facilitating early mobilization.
Read more
The IL/IH block is performed by injecting a local anesthetic into the fascial plane between the transversus abdominis and internal oblique muscles, targeting the ilioinguinal and iliohypogastric nerves, which are branches of the L1 spinal nerve. The TAP block, first described by Rafi in 2001, involves injecting local anesthetic into the fascial plane between the internal oblique and transversus abdominis muscles within the Petit triangle, where the T6-T11 spinal nerve branches responsible for abdominal wall innervation are located. The quadratus lumborum block (QLB) was initially described by Blanco. The first version, known as QLB1, involves posterior injection of local anesthetic lateral to the quadratus lumborum muscle. In 2013, Jens Børglum introduced the transmuscular variant (QLB3), where the local anesthetic is administered between the quadratus lumborum and psoas muscles.
In this study, we aimed to compare postoperative outcomes in patients undergoing inguinal hernia repair under spinal anesthesia, with and without additional peripheral nerve blocks (IL/IH block, TAP block, and QLB). Specifically, we evaluated pain levels using the Visual Analog Scale (VAS) at the 30th minute, 2nd, 6th, 12th, and 24th hours postoperatively. We also assessed opioid-related side effects such as nausea and vomiting associated with patient-controlled analgesia (PCA) using tramadol, the total bolus and infusion doses of tramadol administered, and the amount of additional analgesia in the form of paracetamol. These outcomes were compared among the different block groups and with a control group that received only spinal anesthesia without any additional block.
- Conditions
- Inguinal Hernia, Transversus Abdominis Plane (TAP) Block, Iliohypogastric/Ilioinguinal Nerve Block, Quadratus Lumborum Block
- Being tested
- Ilioinguinal/iliohypogastric Nerve Block, Transversus abdominis plane (TAP) block, Quadratus Lumborum Block (QLB)
- Keywords
- Inguinal hernia, Ilioinguinal-iliohypogastric block, Transversus abdominis plane block, Quadratus lumborum block
- Medical subject headings
- Hernia, Inguinal, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ilioinguinal/iliohypogastric Nerve BlockProcedure or surgery
The aim of this study is to compare the analgesic efficacy of IL/IH block, TAP block, and QLB applied in inguinal hernia cases operated under spinal anesthesia, with each other and with a control group that did not receive any additional block to spinal anesthesia.
Transversus abdominis plane (TAP) blockProcedure or surgery
The aim of this study is to compare the analgesic efficacy of IL/IH block, TAP block, and QLB applied in inguinal hernia cases operated under spinal anesthesia, with each other and with a control group that did not receive any additional block to spinal anesthesia.
Quadratus Lumborum Block (QLB)Procedure or surgery
The aim of this study is to compare the analgesic efficacy of IL/IH block, TAP block, and QLB applied in inguinal hernia cases operated under spinal anesthesia, with each other and with a control group that did not receive any additional block to spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Ilioinguinal/Iliohypogastric Block | Experimental | After spinal anesthesia was applied, a preoperative ilioinguinal/iliohypogastric block was administered to the side to be operated on. Receives: Procedure: Ilioinguinal/iliohypogastric Nerve Block |
| Transversus abdominis plane (TAP) block | Experimental | After spinal anesthesia was applied, a preoperative transversus abdominis plane (TAP) block was administered to the side to be operated on. Receives: Procedure: Transversus abdominis plane (TAP) block |
| Quadratus Lumborum Block | Experimental | After spinal anesthesia was applied, a preoperative quadratus lumborum block (QLB) was administered to the side to be operated on. Receives: Procedure: Quadratus Lumborum Block (QLB) |
| Control | No intervention | No block was applied after spinal anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score
Postoperative pain will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (the worst imaginable pain). Pain scores will be recorded at predefined time points during rest and movement.
Measured: Postoperative 30th minute, 2nd, 6th, 12th and 24th hours
Secondary outcomes (1)
Total Opioid Consumption at 24 Hours.
For patient-controlled analgesia, tramadol 300 mg was prepared in 100 cc of isotonic saline with a concentration of 3 mg/cc. The infusion rate was set at 3 mL/hour, with a 5 mL bolus dose, a lock-out time of 4 hours, and the device was set to be used for 24 hours. In patients with a VAS score of 4 or higher despite opioid demand from the patient-controlled analgesia device, an additional 1 gram of IV paracetamol was planned to be administered as an adjunct analgesic. Total infusion and bolus doses of tramadol over 24 hours were recorded.
Measured: At the end of the 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start28 Jun 2022
- Primary completion28 Jun 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Gültekin, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997536
- Sponsor's protocol ID
- NamikKU-AGultekin-Meltem2025
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savas Ozdemir M, Gultekin A, Sahin A, Arar C. Analgesic efficacy of ilioinguinal/iliohypogastric, transversus abdominis plane, and quadratus lumborum blocks in inguinal hernia surgery: A prospective randomized controlled trial. J Int Med Res. 2026 Jul;54(7):3000605261463857. doi: 10.1177/03000605261463857. Epub 2026 Jul 1.
PubMed 42383898
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Ultrasound-Guided Ilioinguinal-Iliohypogastric Block, Transversus Abdominis Plane Block, and Quadratus Lumborum Block in Inguinal Hernia Surgery: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06997536
- Acronym / sponsor ID
- NamikKU-AGultekin-Meltem2025
- Conditions
- Inguinal Hernia, Transversus Abdominis Plane (TAP) Block, Iliohypogastric/Ilioinguinal Nerve Block, Quadratus Lumborum Block
- Keywords
- Inguinal hernia, Ilioinguinal-iliohypogastric block, Transversus abdominis plane block, Quadratus lumborum block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 30 May 2025 (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.
Inguinal hernia is a common condition, particularly among male patients, and represents one of the most frequent indications for lower abdominal surgeries. Postoperative acute pain and, more importantly, the progression of acute pain into chronic pain, remain significant challenges in the postoperative period. Effective postoperative pain management is therefore crucial in inguinal hernia repair.
In addition to systemic analgesia, various regional anesthesia techniques are employed in this setting. In recent years, peripheral nerve blocks such as the ilioinguinal-iliohypogastric (IL/IH) block, transversus abdominis plane (TAP) block, and quadratus lumborum block (QLB) have gained popularity for postoperative analgesia. These techniques offer several advantages, including reduced opioid consumption and decreased need for additional analgesics, while also minimizing hemodynamic instability and facilitating early mobilization.
The IL/IH block is performed by injecting a local anesthetic into the fascial plane between the transversus abdominis and internal oblique muscles, targeting the ilioinguinal and iliohypogastric nerves, which are branches of the L1 spinal nerve. The TAP block, first described by Rafi in 2001, involves injecting local anesthetic into the fascial plane between the internal oblique and transversus abdominis muscles within the Petit triangle, where the T6-T11 spinal nerve branches responsible for abdominal wall innervation are located. The quadratus lumborum block (QLB) was initially described by Blanco. The first version, known as QLB1, involves posterior injection of local anesthetic lateral to the quadratus lumborum muscle. In 2013, Jens Børglum introduced the transmuscular variant (QLB3), where the local anesthetic is administered between the quadratus lumborum and psoas muscles.
In this study, we aimed to compare postoperative outcomes in patients undergoing inguinal hernia repair under spinal anesthesia, with and without additional peripheral nerve blocks (IL/IH block, TAP block, and QLB). Specifically, we evaluated pain levels using the Visual Analog Scale (VAS) at the 30th minute, 2nd, 6th, 12th, and 24th hours postoperatively. We also assessed opioid-related side effects such as nausea and vomiting associated with patient-controlled analgesia (PCA) using tramadol, the total bolus and infusion doses of tramadol administered, and the amount of additional analgesia in the form of paracetamol. These outcomes were compared among the different block groups and with a control group that received only spinal anesthesia without any additional block.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ilioinguinal/Iliohypogastric Block | Experimental | Procedure: Ilioinguinal/iliohypogastric Nerve BlockAfter spinal anesthesia was applied, a preoperative ilioinguinal/iliohypogastric block was administered to the side to be operated on. |
| Transversus abdominis plane (TAP) block | Experimental | Procedure: Transversus abdominis plane (TAP) blockAfter spinal anesthesia was applied, a preoperative transversus abdominis plane (TAP) block was administered to the side to be operated on. |
| Quadratus Lumborum Block | Experimental | Procedure: Quadratus Lumborum Block (QLB)After spinal anesthesia was applied, a preoperative quadratus lumborum block (QLB) was administered to the side to be operated on. |
| Control | No intervention | –No block was applied after spinal anesthesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients classified as ASA I and II
- Patients aged 18 to 75 years
- Patients undergoing unilateral inguinal hernia surgery under spinal anesthesia
Key exclusion criteria (3 listed)
- Patients with preoperative neurological sequelae
- Patients with a BMI >30
- Patients who refused to participate in the study
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 |
|---|---|---|
| Ilioinguinal/iliohypogastric Nerve BlockThe aim of this study is to compare the analgesic efficacy of IL/IH block, TAP block, and QLB applied in inguinal hernia cases operated under spinal anesthesia, with each other and with a control group that did not receive any additional block to spinal anesthesia. | Procedure or surgery | Ilioinguinal/Iliohypogastric Block |
| Transversus abdominis plane (TAP) blockThe aim of this study is to compare the analgesic efficacy of IL/IH block, TAP block, and QLB applied in inguinal hernia cases operated under spinal anesthesia, with each other and with a control group that did not receive any additional block to spinal anesthesia. | Procedure or surgery | Transversus abdominis plane (TAP) block |
| Quadratus Lumborum Block (QLB)The aim of this study is to compare the analgesic efficacy of IL/IH block, TAP block, and QLB applied in inguinal hernia cases operated under spinal anesthesia, with each other and with a control group that did not receive any additional block to spinal anesthesia. | Procedure or surgery | Quadratus Lumborum Block |
Primary outcome
Postoperative Pain Score
Time frame: Postoperative 30th minute, 2nd, 6th, 12th and 24th hours
Postoperative pain will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (the worst imaginable pain). Pain scores will be recorded at predefined time points during rest and movement.
1 secondary outcome
Total Opioid Consumption at 24 Hours.
Time frame: At the end of the 24th hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 42383898Savas Ozdemir M, Gultekin A, Sahin A, Arar C. Analgesic efficacy of ilioinguinal/iliohypogastric, transversus abdominis plane, and quadratus lumborum blocks in inguinal hernia surgery: A prospective randomized controlled trial. J Int Med Res. 2026 Jul;54(7):3000605261463857. doi: 10.1177/03000605261463857. Epub 2026 Jul 1.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ilioinguinal/iliohypogastric Nerve Block, Transversus abdominis plane (TAP) block and Quadratus Lumborum Block (QLB) in people with Inguinal Hernia and Transversus Abdominis Plane (TAP) Block, run by Namik Kemal University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (time frame: Postoperative 30th minute, 2nd, 6th, 12th and 24th hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06997536, which also lists 1 linked publication.
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 30 May 2025.