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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-07-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Inguinal Hernias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be a randomized prospective , double-blind, controlled trial conducted in a tertiary care surgical unit.

A total of 100 patients (50 in each group) undergoing lower Inguinal hernia surgery will be enrolled based on power analysis.

Anesthetic Technique

* Group A: Spinal anesthesia will be administered using a standard technique with a 25G spinal needle, targeting the appropriate vertebral level.
* Group B: In addition to spinal anesthesia, an ultrasound-guided ilioinguinal nerve block will be performed post to the surgical incision.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intrathecal Mixture Block

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

Group Type ACTIVE_COMPARATOR

Ilioinguinal/iliohypogastric Nerve Block

Intervention Type DRUG

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

Intrathecal Placebo

17 cc of Ns/s

Group Type PLACEBO_COMPARATOR

Ilioinguinal/iliohypogastric with Placebo Block

Intervention Type OTHER

17 cc of Placebo

Interventions

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Ilioinguinal/iliohypogastric Nerve Block

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

Intervention Type DRUG

Ilioinguinal/iliohypogastric with Placebo Block

17 cc of Placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes