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NCT Number: NCT07049835

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.

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Key information

Conditions

Inguinal Hernias Hernia Hernia, Abdominal Hernia, Inguinal Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Makassed General Hospital

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Allergy to local anesthetics
  • Coagulation disorders
  • Infection at the injection site
  • Patients with neurological conditions affecting lower limbs

Treatment and study plan

Ilioinguinal/iliohypogastric Nerve Block

Drug

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

Ilioinguinal/iliohypogastric with Placebo Block

Other

17 cc of Placebo

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Makassed General Hospital

Other

Registry information

Official study title

A Double-Blind Randomized Controlled Trial of Ilioinguinal Nerve Block With Local Anesthetic vs. Placebo in Inguinal Hernia Repair Under Spinal Anesthesia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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