Inguinal HerniasPhase 1NCT07049835
Ilioinguinal Nerve Block With Local Anesthetic vs. Placebo in Inguinal Hernia Repair Under Spinal Anesthesia
A Phase 1 study testing Ilioinguinal/iliohypogastric Nerve Block in people with Inguinal Hernias, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Postoperative pain management remains a critical area of concern in surgical practices, especially in procedures involving the lower abdomen and pelvis. Inguinal Hernia is considered among few surgeries that may lead to chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernias
- What is being tested?
- Ilioinguinal/iliohypogastric Nerve Block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jun 2025to 30 Jul 2026
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years
- ASA physical status I-III
- Scheduled for elective lower abdominal surgery (e.g., inguinal hernia repair, cesarean section)
Who cannot join
- Allergy to local anesthetics
- Coagulation disorders
- Infection at the injection site
- Patients with neurological conditions affecting lower limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind Randomized Controlled Trial of Ilioinguinal Nerve Block With Local Anesthetic vs. Placebo in Inguinal Hernia Repair Under Spinal Anesthesia
Postoperative pain management remains a critical area of concern in surgical practices, especially in procedures involving the lower abdomen and pelvis. Inguinal Hernia is considered among few surgeries that may lead to chronic pain. Spinal anesthesia is a commonly utilized modality because of its efficacy in pain control and rapid recovery. However, the addition of peripheral nerve blocks, such as the ilioinguinal nerve block, may provide enhanced pain relief and reduce opioid consumption postoperatively. This study aims to evaluate the effectiveness of spinal anesthesia alone compared to spinal anesthesia supplemented with ultrasound-guided ilioinguinal and iliohypo-gastric nerve block in managing postoperative pain.
Read the detailed description
Objectives
- Primary Objective: To compare the postoperative pain scores (using a standardized numerical rating scale) between patients receiving spinal anesthesia alone and those receiving spinal anesthesia with ultrasound-guided ilioinguinal nerve block.
- Secondary Objectives:
- To assess the total opioid consumption in the first 24 hours post-surgery.
- To evaluate the time to first analgesic request postoperatively.
- Patient Satisfaction score post-op >> at rest , coughing , ambulation ( LEKENT SCORE ) .
Hypotheses
- Hypothesis 1: Patients receiving spinal anesthesia with an ilioinguinal nerve block will experience significantly lower postoperative pain scores compared to those receiving spinal anesthesia alone.
- Hypothesis 2: Patients receiving spinal anesthesia with an ilioinguinal nerve block will require less opioid medication in the first 24 hours post-surgery.
- Conditions
- Inguinal Hernias
- Being tested
- Ilioinguinal/iliohypogastric Nerve Block, Ilioinguinal/iliohypogastric with Placebo Block
- Keywords
- Bupivacaine Hydrochloride, Spinal Anesthesia, Nerve Blocks, Iliohypogastric Nerve Neuralgia, Ilioinguinal Neuralgia, Adults, Lidocaine Hydrochloride, Normal Saline, Sulfentanyl
- Medical subject headings
- Hernia, Inguinal, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ilioinguinal/iliohypogastric Nerve BlockDrug
15cc 0.25% of Bupivacaine + Dexamethasone 8 mg 2cc
Ilioinguinal/iliohypogastric with Placebo BlockOther
17 cc of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Mixture Block | Active comparator | 15cc 0.25% of Bupivacaine + Dexamethasone 8 mg 2cc Receives: Drug: Ilioinguinal/iliohypogastric Nerve Block |
| Intrathecal Placebo | Placebo comparator | 17 cc of Ns/s Receives: Other: Ilioinguinal/iliohypogastric with Placebo Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain management
Pain scores will be assessed using an 11-point numerical rating scale (0-10) at 1, 6, 12, and 24 hours postoperatively.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Jun 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniasStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a randomized prospective , double-blind, controlled trial conducted in a tertiary care surgical unit. A total of 100 patients (50 in each group) undergoing lower Inguinal hernia surgery will be enrolled based on power analysis. Anesthetic Technique * Group A: Spinal anesthesia will be administered using a standard technique with a 25G spinal needle, targeting the appropriate vertebral level. * Group B: In addition to spinal anesthesia, an ultrasound-guided ilioinguinal nerve block will be performed post to the surgical incision.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad-Ali Barada, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049835
- Sponsor's protocol ID
- MGH-06-25017
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yilmazlar A, Bilgel H, Donmez C, Guney A, Yilmazlar T, Tokat O. Comparison of ilioinguinal-iliohypogastric nerve block versus spinal anesthesia for inguinal herniorrhaphy. South Med J. 2006 Jan;99(1):48-51. doi: 10.1097/01.smj.0000197298.48311.80.
PubMed 16466122Zhou Y, Chen M, Zhang Y, Zhou H, Yu X, Chen G. Ilioinguinal/iliohypogastric nerve block versus transversus abdominis plane block for pain management following inguinal hernia repair surgery: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Oct;98(42):e17545. doi: 10.1097/MD.0000000000017545.
PubMed 31626118
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomized Controlled Trial of Ilioinguinal Nerve Block With Local Anesthetic vs. Placebo in Inguinal Hernia Repair Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07049835
- Acronym / sponsor ID
- MGH-06-25017
- Conditions
- Inguinal Hernias
- Keywords
- Bupivacaine Hydrochloride, Spinal Anesthesia, Nerve Blocks, Iliohypogastric Nerve Neuralgia, Ilioinguinal Neuralgia, Adults, Lidocaine Hydrochloride, Normal Saline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 3 Jul 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.
Postoperative pain management remains a critical area of concern in surgical practices, especially in procedures involving the lower abdomen and pelvis. Inguinal Hernia is considered among few surgeries that may lead to chronic pain. Spinal anesthesia is a commonly utilized modality because of its efficacy in pain control and rapid recovery. However, the addition of peripheral nerve blocks, such as the ilioinguinal nerve block, may provide enhanced pain relief and reduce opioid consumption postoperatively. This study aims to evaluate the effectiveness of spinal anesthesia alone compared to spinal anesthesia supplemented with ultrasound-guided ilioinguinal and iliohypo-gastric nerve block in managing postoperative pain.
Detailed description
Objectives
- Primary Objective: To compare the postoperative pain scores (using a standardized numerical rating scale) between patients receiving spinal anesthesia alone and those receiving spinal anesthesia with ultrasound-guided ilioinguinal nerve block.
- Secondary Objectives:
- To assess the total opioid consumption in the first 24 hours post-surgery.
- To evaluate the time to first analgesic request postoperatively.
- Patient Satisfaction score post-op >> at rest , coughing , ambulation ( LEKENT SCORE ) .
Hypotheses
- Hypothesis 1: Patients receiving spinal anesthesia with an ilioinguinal nerve block will experience significantly lower postoperative pain scores compared to those receiving spinal anesthesia alone.
- Hypothesis 2: Patients receiving spinal anesthesia with an ilioinguinal nerve block will require less opioid medication in the first 24 hours post-surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This study will be a randomized prospective , double-blind, controlled trial conducted in a tertiary care surgical unit. A total of 100 patients (50 in each group) undergoing lower Inguinal hernia surgery will be enrolled based on power analysis. Anesthetic Technique * Group A: Spinal anesthesia will be administered using a standard technique with a 25G spinal needle, targeting the appropriate vertebral level. * Group B: In addition to spinal anesthesia, an ultrasound-guided ilioinguinal nerve block will be performed post to the surgical incision.
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Mixture Block | Active comparator | Drug: Ilioinguinal/iliohypogastric Nerve Block15cc 0.25% of Bupivacaine + Dexamethasone 8 mg 2cc |
| Intrathecal Placebo | Placebo comparator | Other: Ilioinguinal/iliohypogastric with Placebo Block17 cc of Ns/s |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-65 years
- ASA physical status I-III
- Scheduled for elective lower abdominal surgery (e.g., inguinal hernia repair, cesarean section)
Key exclusion criteria (4 listed)
- Allergy to local anesthetics
- Coagulation disorders
- Infection at the injection site
- Patients with neurological conditions affecting lower limbs
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 Block15cc 0.25% of Bupivacaine + Dexamethasone 8 mg 2cc | Drug | Intrathecal Mixture Block |
| Ilioinguinal/iliohypogastric with Placebo Block17 cc of Placebo | Other | Intrathecal Placebo |
Primary outcome
Postoperative pain management
Time frame: 24 hours
Pain scores will be assessed using an 11-point numerical rating scale (0-10) at 1, 6, 12, and 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 3 Jul 2025.
- Results publication: PubMed 16466122Yilmazlar A, Bilgel H, Donmez C, Guney A, Yilmazlar T, Tokat O. Comparison of ilioinguinal-iliohypogastric nerve block versus spinal anesthesia for inguinal herniorrhaphy. South Med J. 2006 Jan;99(1):48-51. doi: 10.1097/01.smj.0000197298.48311.80.
- Results publication: PubMed 31626118Zhou Y, Chen M, Zhang Y, Zhou H, Yu X, Chen G. Ilioinguinal/iliohypogastric nerve block versus transversus abdominis plane block for pain management following inguinal hernia repair surgery: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Oct;98(42):e17545. doi: 10.1097/MD.0000000000017545.
- Individual participant dataSharing planned: No
Related trials for Inguinal Hernias
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative 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. 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 Phase 1 study testing Ilioinguinal/iliohypogastric Nerve Block in people with Inguinal Hernias, run by Makassed General Hospital at 1 site in Lebanon.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 3 Jul 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 Lebanon. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 management (time frame: 24 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 NCT07049835, which also lists 2 linked publications.
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 3 Jul 2025.