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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07049835
Enrollment
100
Registered
2025-07-03
Start date
2025-06-01
Completion date
2026-07-30
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernias

Keywords

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

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.

Interventions

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

OTHERIlioinguinal/iliohypogastric with Placebo Block

17 cc of Placebo

Sponsors

Makassed General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain management24 hoursPain scores will be assessed using an 11-point numerical rating scale (0-10) at 1, 6, 12, and 24 hours postoperatively.

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026