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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Egypt
      • Cairo, Egypt, Egypt, 11865
        • Al Azhar University
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Ultrasound-guided lateral quadratus lumborum block
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.
Procedure: Combined ilio-inguinal/ilio-hypogastric/genitofemoral (II-IH-GFN) 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Al-Azhar University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Benha University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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