Postoperative Analgesia of Inguinal Hernia Repair in AdultsPhase 3NCT07343570
Comparison of Quadratus Lumborum and Combined Groin Nerve Blocks for Postoperative Analgesia After Open Inguinal Hernia Repair.
A Phase 3 study testing Ultrasound-guided lateral quadratus lumborum block and Combined ilio-inguinal/ilio-hypogastric/genitofemoral (II-IH-GFN) block in people with Postoperative Analgesia of Inguinal Hernia Repair in Adults, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This double-blind randomized controlled trial aimes to compares two ultrasound-guided regional techniques-lateral quadratus lumborum block versus combined ilio-inguinal/ilio-hypogastric/genitofemoral (II-IH-GFN) block-for postoperative analgesia after elective unilateral open inguinal hernia repair under spinal… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Analgesia of Inguinal Hernia Repair in Adults
- What is being tested?
- Ultrasound-guided lateral quadratus lumborum block and Combined ilio-inguinal/ilio-hypogastric/genitofemoral (II-IH-GFN) block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jan 2026to 30 Dec 2026
- Phase
- Phase 3
- 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
- Adults aged 18-75 years.
- ASA physical status I-III.
- Scheduled for elective unilateral open inguinal hernia repair under standardized spinal anesthesia.
- Able to understand and use the Visual Analogue Scale (VAS).
- Provided written informed consent.
Who cannot join
- Allergy to local anesthetics.
- Coagulopathy or current use of anticoagulants contraindicating peripheral nerve blocks.
- Infection at the injection site.
- Chronic opioid use (daily opioids >2 weeks) or chronic pain syndromes.
- Body mass index (BMI) >40 kg/m².
- Conversion to other surgery or bilateral repair.
- Pregnant patients.
- Refusal to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Al Azhar University
Cairo, Egypt, 11865
Neveen Kohaf, Ph.D, 01060383012, nevenabdo@azhar.edu.eg
Hany Baumy, M.D
About this study
Official title: Comparing Ultrasound-guided Lateral Quadratus Lumborum Block Versus Combined Ilio-inguinal/Ilio-hypogastric /Genitofemoral Block for Postoperative Analgesia After Open Inguinal Hernia Repair: A Double-blind Randomized Controlled Trial
This double-blind randomized controlled trial aimes to compares two ultrasound-guided regional techniques-lateral quadratus lumborum block versus combined ilio-inguinal/ilio-hypogastric/genitofemoral (II-IH-GFN) block-for postoperative analgesia after elective unilateral open inguinal hernia repair under spinal anesthesia in adults.
- Being tested
- Ultrasound-guided lateral quadratus lumborum block, Combined ilio-inguinal/ilio-hypogastric/genitofemoral (II-IH-GFN) block
- Keywords
- Quadratus lumborum [QL] block, Ilioinguinal-iliohypogastric (IIIH) nerve block, Genitofemoral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided lateral quadratus lumborum blockProcedure or surgery
Ultrasound-guided lateral quadratus lumborum block. Local anesthetic: 30 ml of (Ropivacaine 0.2%) is injected at the appropriate fascial level.
Combined ilio-inguinal/ilio-hypogastric/genitofemoral (II-IH-GFN) blockProcedure or surgery
Ultrasound-guided ilio-inguinal and ilio-hypogastric block. Local anesthesia: 20 ml of 0.2% ropivacaine for ilio-inguinal and ilio-hypogastric block + 10 ml of 0.2% ropivacaine for genitofemoral anaesthesia, total injection volume = 30 ml.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Quadratus lumborum block) | Active comparator | Ultrasound-guided lateral quadratus lumborum block. Local anesthetic: 30 ml of (Ropivacaine 0.2%) is injected at the appropriate fascial level. Receives: Procedure: Ultrasound-guided lateral quadratus lumborum block |
| Group 2 ( Ilio-inguinal and ilio-hypogastric block) | Active comparator | Ultrasound-guided ilio-inguinal and ilio-hypogastric block. Local anesthesia: 20 ml of 0.2% ropivacaine for ilio-inguinal and ilio-hypogastric block + 10 ml of 0.2% ropivacaine for genitofemoral anaesthesia, total injection volume = 30 ml. Receives: Procedure: Combined ilio-inguinal/ilio-hypogastric/genitofemoral (II-IH-GFN) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption in the first 24 hours postoperatively
Measures the total amount of opioid analgesics (expressed as morphine milligram equivalents, MME) consumed during the first postoperative 24 hours. It reflects overall analgesic efficacy of the two block techniques.
Measured: 24 hours after surgery.
Secondary outcomes (8)
Pain intensity (VAS pain scores at rest )
Assesses the level of postoperative pain at rest using the Visual Analogue Scale (VAS), where 0 = no pain and 10 = worst imaginable pain.
Measured: 24 hours postoperatively.
Pain intensity (VAS pain scores at movement)
Assesses the level of postoperative pain during movement using the Visual Analogue Scale (VAS), where 0 = no pain and 10 = worst imaginable pain.
Measured: 24 hours postoperatively.
Time to first analgesic request
Determines the duration of effective analgesia provided by each block, defined as the interval from completion of the block to the first patient request for additional analgesia.
Measured: 24 hours.
Proportion of patients requiring rescue opioid analgesia
Percentage of patients who required additional opioid analgesics beyond the planned postoperative regimen, indicating inadequate analgesia from the primary block.
Measured: 24 hours.
Incidence of postoperative block-related complications
Evaluates safety of the blocks by recording complications such as hematoma, local anesthetic toxicity, or impaired mobility.
Measured: 24 hours.
Patient satisfaction score
Patient satisfaction with postoperative pain control will be evaluated using a 5-point Likert scale, allowing a simple yet reliable measure of the patient's overall analgesic experience. Each participant will rate their satisfaction as follows: 1 for "very dissatisfied," indicating poor pain relief and marked discomfort; 2 for "dissatisfied," reflecting inadequate but tolerable pain control; 3 for "neutral," representing acceptable analgesia without a clear sense of satisfaction; 4 for "satisfied," denoting good pain relief and minimal discomfort; and 5 for "very satisfied," corresponding to excellent pain control and full contentment with the postoperative analgesia regimen.
Measured: Assessed at 24 hours postoperatively.
Post-anesthesia care unit (PACU) stay duration
Measures the time spent in the PACU
Measured: 24 hours
Total hospital stay duration
Measures total length of hospital stay.
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 posted15 Jan 2026
- Study start28 Jan 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Analgesia of Inguinal Hernia Repair in AdultsStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343570
- Sponsor's protocol ID
- RC. 12.9.2025
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared upon a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Ultrasound-guided Lateral Quadratus Lumborum Block Versus Combined Ilio-inguinal/Ilio-hypogastric /Genitofemoral Block for Postoperative Analgesia After Open Inguinal Hernia Repair: A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07343570
- Acronym / sponsor ID
- RC. 12.9.2025
- Keywords
- Quadratus lumborum [QL] block, Ilioinguinal-iliohypogastric (IIIH) nerve block, Genitofemoral block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 28 Jan 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Jan 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.
This double-blind randomized controlled trial aimes to compares two ultrasound-guided regional techniques-lateral quadratus lumborum block versus combined ilio-inguinal/ilio-hypogastric/genitofemoral (II-IH-GFN) block-for postoperative analgesia after elective unilateral open inguinal hernia repair under spinal anesthesia in adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Quadratus lumborum block) | Active comparator | Procedure: Ultrasound-guided lateral quadratus lumborum blockUltrasound-guided lateral quadratus lumborum block. Local anesthetic: 30 ml of (Ropivacaine 0.2%) is injected at the appropriate fascial level. |
| Group 2 ( Ilio-inguinal and ilio-hypogastric block) | Active comparator | Procedure: Combined ilio-inguinal/ilio-hypogastric/genitofemoral (II-IH-GFN) blockUltrasound-guided ilio-inguinal and ilio-hypogastric block. Local anesthesia: 20 ml of 0.2% ropivacaine for ilio-inguinal and ilio-hypogastric block + 10 ml of 0.2% ropivacaine for genitofemoral anaesthesia, total injection volume = 30 ml. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-75 years.
- ASA physical status I-III.
- Scheduled for elective unilateral open inguinal hernia repair under standardized spinal anesthesia.
- Able to understand and use the Visual Analogue Scale (VAS).
- Provided written informed consent.
Key exclusion criteria (8 listed)
- Allergy to local anesthetics.
- Coagulopathy or current use of anticoagulants contraindicating peripheral nerve blocks.
- Infection at the injection site.
- Chronic opioid use (daily opioids >2 weeks) or chronic pain syndromes.
- Body mass index (BMI) >40 kg/m².
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 |
|---|---|---|
| Ultrasound-guided lateral quadratus lumborum blockUltrasound-guided lateral quadratus lumborum block. Local anesthetic: 30 ml of (Ropivacaine 0.2%) is injected at the appropriate fascial level. | Procedure or surgery | Group 1 (Quadratus lumborum block) |
| Combined ilio-inguinal/ilio-hypogastric/genitofemoral (II-IH-GFN) blockUltrasound-guided ilio-inguinal and ilio-hypogastric block. Local anesthesia: 20 ml of 0.2% ropivacaine for ilio-inguinal and ilio-hypogastric block + 10 ml of 0.2% ropivacaine for genitofemoral anaesthesia, total injection volume = 30 ml. | Procedure or surgery | Group 2 ( Ilio-inguinal and ilio-hypogastric block) |
Primary outcome
Cumulative opioid consumption in the first 24 hours postoperatively
Time frame: 24 hours after surgery.
Measures the total amount of opioid analgesics (expressed as morphine milligram equivalents, MME) consumed during the first postoperative 24 hours. It reflects overall analgesic efficacy of the two block techniques.
8 secondary outcomes
Pain intensity (VAS pain scores at rest )
Time frame: 24 hours postoperatively.
Pain intensity (VAS pain scores at movement)
Time frame: 24 hours postoperatively.
Time to first analgesic request
Time frame: 24 hours.
Proportion of patients requiring rescue opioid analgesia
Time frame: 24 hours.
Incidence of postoperative block-related complications
Time frame: 24 hours.
Patient satisfaction score
Time frame: Assessed at 24 hours postoperatively.
Post-anesthesia care unit (PACU) stay duration
Time frame: 24 hours
Total hospital stay duration
Time frame: 24 hours
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 15 Jan 2026.
- Individual participant dataSharing planned: Yes. Data can be shared upon a reasonable request from the corresponding author
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ultrasound-guided lateral quadratus lumborum block and Combined ilio-inguinal/ilio-hypogastric/genitofemoral (II-IH-GFN) block in people with Postoperative Analgesia of Inguinal Hernia Repair in Adults, run by Al-Azhar University at 1 site in Egypt.
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 5 inclusion and 8 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 15 Jan 2026. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Neveen A. Kohaf, Ph.D (01060383012, nevenabdo@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative opioid consumption in the first 24 hours postoperatively (time frame: 24 hours after surgery.). 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 15 Jan 2026.