US-guided Ilioinguinal Blocks Versus Local Infiltration

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

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-11-30

Brief Summary

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Injection of local anesthetic drugs is an effective way to freeze (block) nerves to achieve loss of sensation during surgery and satisfactory pain control afterwards. Many studies have shown that nerve block is associated with higher degree of success in controlling pain after open inguinal hernia repair. Nerve block can be administered by a single injection with a long acting local anesthetic agent using ultrasound guidance. This study is to compare different techniques for freezing the nerves responsible for pain after open inguinal hernia repair. Patients will be randomized to one of two groups. In the first group, participants will receive ultrasound-guided nerve block following induction of general anesthesia but prior to surgical procedure. In the second group, participants will receive local anesthetic injection directly into the wound by the surgeon prior to closure. The investigators will assess the level of pain control for 48 hours after the surgical procedure. Patients will be provided with additional medications for pain relief if necessary. The investigators will also contact participants to follow-up with regard to possible chronic groin pain after 3 months following the surgical procedure.

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Detailed Description

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populations. It is well-known that inguinal hernia surgery can lead to significant degree of acute perioperative pain. At the same time, patients undergoing inguinal hernia operation are at increased risk to develop chronic neuropathic groin pain. In the literature, several approaches to prophylaxis and treatment of perioperative pain have been described including: infiltration of local anesthetics by surgeons, ilioinguonal/iliohypogastric nerve blocks, neuroaxial blockade, and caudal block in pediatric petients.

Recent studies have shown that ultrasound guided ilioinguinal/iliohypogastric nerve block is associated with increased level of safety, improved success rate, and reduction in dose of local anesthetic required compared to the "blind" technique.

The aim of our study is to investigate the role of ultrasound guided ilioinguinal/iliohypogastric nerve block in prevention of perioperative and persistent neuropathic pain following open inguinal hernia repair in comparison with infiltration of local anesthetics by surgeons. In the first randomized group of patients we will perform ultrasound guided ilioinguinal/iliohypogastric nerve block using the same types and amount of local anesthetics. In the second group, patients will receive infiltration of the same type and amount of local anesthetics by surgeons.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ilioinguinal block

Patients in this group will receive an ultrasound-guided ilioinguinal nerve block.

Group Type EXPERIMENTAL

Ilioinguinal block

Intervention Type PROCEDURE

0.25% bupivacaine will be administered on a mg/kg basis

Local infiltration

Patients in this group will receive the standard method of local infiltration of local anesthetic around the surgical site.

Group Type ACTIVE_COMPARATOR

Local infiltration

Intervention Type PROCEDURE

Surgeon will infiltrate incision area with local anesthetic before closure.

Interventions

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Ilioinguinal block

0.25% bupivacaine will be administered on a mg/kg basis

Intervention Type PROCEDURE

Local infiltration

Surgeon will infiltrate incision area with local anesthetic before closure.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA 1-3
* Both gender
* 18 years and older
* Informed consent

Exclusion Criteria

* ASA 4 and more
* Lack of informed consent
* Patients with history of chronic pain
* Patients on regular opioids
* History of allergic reaction to local anesthetics
* Medication or non-medication induced bleeding diastasis
* Infection at the site of injection
* Patients with bilateral hernias
* linguistic difficulties

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No