Predictive Factors for the Effectiveness of the Ilioinguinal Iliohypogastric Nerve Block for Hernia Surgery

NCT06121726 | Completed

• 1 other identifier: VALI
• Study Type: observational
• Target: 343
• Locations: 1 country
• Sites: 1

Brief Summary

Inguinal hernia repair is a common surgical procedure done as day surgery. Because patients need to be discharged on the same day, the choice of anesthesia technique is influenced. One option is the ilioinguinal (II)-iliohypogastric (IH) nerve block, a type of transversus abdominis plane (TAP) block, which has benefits such as faster recovery, better pain control, and reduced opioid use. It also allows for quick discharge, early feeding, and no need for post-anesthesia or recovery unit stay. This study aims to evaluate the success of the II-IH nerve block as the preferred anesthesia strategy for patients undergoing unilateral inguinal hernia repair using the Lichtenstein technique. The study will analyze various factors such as BMI, age, optimal ultrasound vision, amount of anesthesia used, dose of anesthesia administered, time between block execution and incision, and sedative dose needed to determine independent variables of block effectiveness. The study will include patients aged 18 or older, with ASA I-II-III classification, and who provide informed consent. Patients with allergies to local anesthetics, certain medical conditions, obesity, difficulty visualizing target structures, non-cooperative behavior, or taking anticoagulant therapy will be excluded. The study will be conducted at the Sant'Antonio Hospital (Padova University Hospital) operating rooms for one year, aiming to recruit around 400 patients. Informed consent for data processing will be obtained during the preoperative anesthesia visit, and standard anesthesia procedures will be followed during the surgery. As usual care the patient will be monitored before surgery using an electrocardiogram, oxygen saturation measurement, and non-invasive blood pressure. After adequate sedation, the II-IH nerve block will be performed under sterile conditions and ultrasound guidance. Participation in the study does not modify the commonly used anesthesia procedures and does not pose any additional risks or provide direct benefits to the patients. The data collected will be treated confidentially and used exclusively for the study's purposes. Data collection will be conducted through a paper-based form, and only a few variables will be recorded. The study's findings will be made public, even if negative, and will be submitted to the ethics committee within twelve months of data collection completion.

Conditions

Hernia Inguinal; Pain Postoperative; Regional Anesthesia

Keywords

ilioinguinal; iliohypogastric; nerve block; pain; hernia

Outcome Measures

Primary Outcomes (1)

• ilioinguinal-iliohypogastric nerve block failure

  Described as the need of additional local anesthetic, additional opioids and/or general anesthesia

  through surgery completation, an average of 1 hour

Secondary Outcomes (6)

• Total body weight (kg) as predictive parameter for ilioinguinal-iliohypogastric nerve block failure

  through surgery completation, an average of 1 hour

• Time From Block To Skin Incision(minutes) As Predictive Parameter For ilioinguinal-iliohypogastric nerve block failure

  through surgery completation, an average of 1 hour

• Dose of anesthetic(mg) As Predictive Parameter For ilioinguinal-iliohypogastric nerve block failure

  through surgery completation, an average of 1 hour

• Local anesthetic volume(mL) As Predictive Parameter For ilioinguinal-iliohypogastric nerve block failure

  through surgery completation, an average of 1 hour

• Age(years) As Predictive Parameter For ilioinguinal-iliohypogastric nerve block failure

  through surgery completation, an average of 1 hour

Study Arms (1)

Ilioinguinal-Iliohypogastric nerve block

Patients will receive Ilioinguinal-Iliohypogastric nerve block as standard of care

Other: Ilioinguinal-Iliohypogastric nerve block; Drug: Local anesthetic

Interventions

Ilioinguinal-Iliohypogastric nerve block OTHER

local anesthetic will be administered near ilioinguinal-iliohypogastric nerves under ultrasound guidance. Given the observational nature of the study dose and drugs will be decided by the attending anesthesiologist

Ilioinguinal-Iliohypogastric nerve block

Local anesthetic DRUG

Given the observational nature of the study dose and drugs will be decided by the attending anesthesiologist

Ilioinguinal-Iliohypogastric nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing unilateral inguinal hernioplasty

You may qualify if:

• \>18 years old
• Informed consent
• Unilateral inguinal hernioplasty program using the Lichtenstein technique

You may not qualify if:

• Allergy to local anesthesia
• Cardiac, renal, hepatic, central or peripheral neuropathies that are not compensated
• Anticoagulant therapy
• History of coagulopathy (evaluate risk/benefit ratio)
• Infection at the surgical site
• Non-cooperative patient

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University Hospital of Padova

Padua, Veneto, 35127, Italy

Location

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative; Pain; Hernia

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: November 8, 2023
• Study Start: October 13, 2023
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)