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

NCT07049835 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: MGH-06-25017
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernias

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Postoperative pain management

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

  24 hours

Study Arms (2)

Intrathecal Mixture Block

ACTIVE COMPARATOR

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

Drug: Ilioinguinal/iliohypogastric Nerve Block

Intrathecal Placebo

PLACEBO COMPARATOR

17 cc of Ns/s

Other: Ilioinguinal/iliohypogastric with Placebo Block

Interventions

Ilioinguinal/iliohypogastric Nerve Block DRUG

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

Intrathecal Mixture Block

Ilioinguinal/iliohypogastric with Placebo Block OTHER

17 cc of Placebo

Intrathecal Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

Related Publications (2)

• Yilmazlar A, Bilgel H, Donmez C, Guney A, Yilmazlar T, Tokat O. Comparison of ilioinguinal-iliohypogastric nerve block versus spinal anesthesia for inguinal herniorrhaphy. South Med J. 2006 Jan;99(1):48-51. doi: 10.1097/01.smj.0000197298.48311.80.

  PMID: 16466122 BACKGROUND

• Zhou Y, Chen M, Zhang Y, Zhou H, Yu X, Chen G. Ilioinguinal/iliohypogastric nerve block versus transversus abdominis plane block for pain management following inguinal hernia repair surgery: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Oct;98(42):e17545. doi: 10.1097/MD.0000000000017545.

  PMID: 31626118 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Neuralgia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia Attending

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)