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

Makassed General Hospital

Status and phase: Active, not recruiting; Phase 1

Conditions: Inguinal Hernias

Treatments: Other: Ilioinguinal/iliohypogastric with Placebo Block; Drug: Ilioinguinal/iliohypogastric Nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07049835

MGH-06-25017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Intrathecal Mixture Block

Active Comparator group

Description:

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

Treatment:

Drug: Ilioinguinal/iliohypogastric Nerve Block

Intrathecal Placebo

Placebo Comparator group

Description:

17 cc of Ns/s

Treatment:

Other: Ilioinguinal/iliohypogastric with Placebo Block