- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07343570
Comparison of Quadratus Lumborum and Combined Groin Nerve Blocks for Postoperative Analgesia After Open Inguinal Hernia Repair.
January 8, 2026 updated by: Neveen Abd El Maksoad Kohaf, Al-Azhar University
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.
Study Overview
Status
Not yet recruiting
Study Type
Interventional
Enrollment (Estimated)
66
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Neveen A. Kohaf, Ph.D
- Phone Number: 01060383012
- Email: nevenabdo@azhar.edu.eg
Study Locations
-
-
Egypt
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Cairo, Egypt, Egypt, 11865
- Al Azhar University
-
Contact:
- Neveen Kohaf, Ph.D
- Phone Number: 01060383012
- Email: nevenabdo@azhar.edu.eg
-
Principal Investigator:
- Hany Baumy, M.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1 (Quadratus lumborum block)
Ultrasound-guided lateral quadratus lumborum block.
Local anesthetic: 30 ml of (Ropivacaine 0.2%) is injected at the appropriate fascial level.
|
Ultrasound-guided lateral quadratus lumborum block.
Local anesthetic: 30 ml of (Ropivacaine 0.2%) is injected at the appropriate fascial level.
|
|
Active Comparator: Group 2 ( Ilio-inguinal and ilio-hypogastric block)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24 hours after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity (VAS pain scores at rest )
Time Frame: 24 hours postoperatively.
|
Assesses the level of postoperative pain at rest using the Visual Analogue Scale (VAS), where 0 = no pain and 10 = worst imaginable pain.
|
24 hours postoperatively.
|
|
Pain intensity (VAS pain scores at movement)
Time Frame: 24 hours postoperatively.
|
Assesses the level of postoperative pain during movement using the Visual Analogue Scale (VAS), where 0 = no pain and 10 = worst imaginable pain.
|
24 hours postoperatively.
|
|
Time to first analgesic request
Time Frame: 24 hours.
|
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.
|
24 hours.
|
|
Proportion of patients requiring rescue opioid analgesia
Time Frame: 24 hours.
|
Percentage of patients who required additional opioid analgesics beyond the planned postoperative regimen, indicating inadequate analgesia from the primary block.
|
24 hours.
|
|
Incidence of postoperative block-related complications
Time Frame: 24 hours.
|
Evaluates safety of the blocks by recording complications such as hematoma, local anesthetic toxicity, or impaired mobility.
|
24 hours.
|
|
Patient satisfaction score
Time Frame: Assessed at 24 hours postoperatively.
|
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.
|
Assessed at 24 hours postoperatively.
|
|
Post-anesthesia care unit (PACU) stay duration
Time Frame: 24 hours
|
Measures the time spent in the PACU
|
24 hours
|
|
Total hospital stay duration
Time Frame: 24 hours
|
Measures total length of hospital stay.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 28, 2026
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
December 30, 2026
Study Registration Dates
First Submitted
December 26, 2025
First Submitted That Met QC Criteria
January 8, 2026
First Posted (Actual)
January 15, 2026
Study Record Updates
Last Update Posted (Actual)
January 15, 2026
Last Update Submitted That Met QC Criteria
January 8, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC. 12.9.2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data can be shared upon a reasonable request from the corresponding author
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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