ClinicalTrials.gg
Active, not recruitingNCT07049835Updated Jul 3, 2025

Ilioinguinal Nerve Block With Local Anesthetic vs. Placebo in Inguinal Hernia Repair Under Spinal Anesthesia

A Phase 1 interventional study of Ilioinguinal/iliohypogastric Nerve Block and Ilioinguinal/iliohypogastric with Placebo Block in Inguinal Hernias, sponsored by Makassed General Hospital. Active, not recruiting at 1 site in Lebanon. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-03.

Sponsored by Makassed General Hospital · Phase 1, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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

  1. 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.
  2. 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.
02

Conditions studied

  • Inguinal Hernias

Keywords

  • Bupivacaine Hydrochloride
  • Spinal Anesthesia
  • Nerve Blocks
  • Iliohypogastric Nerve Neuralgia
  • Ilioinguinal Neuralgia
  • Adults
  • Lidocaine Hydrochloride
  • Normal Saline
  • Sulfentanyl
03

In context

Hernia, Inguinal

543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.

This study's enrollment of 100 is above the median of 90 across 395 interventional studies indexed under Hernia, Inguinal.

Browse Hernia, Inguinal studies →

Lead sponsor

Makassed General Hospital is the lead sponsor of 39 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18-65 years
  • I-III
  • Scheduled for elective lower abdominal surgery (e.g., inguinal hernia repair, cesarean section)

Exclusion criteria

Exclusion Criteria:

  • Allergy to local anesthetics
  • Coagulation disorders
  • Infection at the injection site
  • Patients with neurological conditions affecting lower limbs
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Intrathecal Mixture Block

    15cc 0.25% of Bupivacaine + Dexamethasone 8 mg 2cc

    Drug: Ilioinguinal/iliohypogastric Nerve Block

  • Placebo comparator
    Intrathecal Placebo

    17 cc of Ns/s

    Other: Ilioinguinal/iliohypogastric with Placebo Block

Interventions

  • DrugIlioinguinal/iliohypogastric Nerve Block

    15cc 0.25% of Bupivacaine + Dexamethasone 8 mg 2cc

  • OtherIlioinguinal/iliohypogastric with Placebo Block

    17 cc of Placebo

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours

07

Study locations

1 site
  • Makassed General Hospital
    Beirut, Lebanon
08

References and documents

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 16466122 ↗
  • Zhou 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2025 (actual). Primary completion is estimated for Jul 2026, 13 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2025
First posted
Jul 3, 2025
StartActual
Jun 1, 2025
Primary completionEst.
Jul 30, 2026
CompletionEst.
Jul 30, 2026
Last update
Jul 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07049835
Lead sponsor
Makassed General Hospital
Responsible party
Mohamad-Ali Barada (Anesthesia Attending, Makassed General Hospital) — Principal investigator
First posted
Jul 3, 2025
Start date
Jun 1, 2025
Primary completion
Jul 30, 2026 (estimated)
Completion
Jul 30, 2026 (estimated)
Last update
Jul 3, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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