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

Not Applicable

Active, not recruiting

• Conditions: Inguinal Hernias
• Interventions: Drug: Ilioinguinal/iliohypogastric Nerve Block; Other: Ilioinguinal/iliohypogastric with Placebo Block

• Registration Number: NCT07049835
• Lead Sponsor: Makassed General Hospital

Brief 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.

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.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-25
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03
• Primary Completion: 2026-07-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal Mixture Block	Ilioinguinal/iliohypogastric Nerve Block	15cc 0.25% of Bupivacaine + Dexamethasone 8 mg 2cc
Intrathecal Placebo	Ilioinguinal/iliohypogastric with Placebo Block	17 cc of Ns/s

Primary Outcome Measures

Name	Time	Method
Postoperative pain management	24 hours	Pain scores will be assessed using an 11-point numerical rating scale (0-10) at 1, 6, 12, and 24 hours postoperatively.

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon