US-guided Ilioinguinal Blocks Versus Local Infiltration

Not Applicable

Terminated

• Conditions: Pain, Postoperative
• Interventions: Procedure: Ilioinguinal block; Procedure: Local infiltration

• Registration Number: NCT01871181
• Lead Sponsor: University of Alberta

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-06
• Status Verified: 2016-10
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ilioinguinal block	Ilioinguinal block	Patients in this group will receive an ultrasound-guided ilioinguinal nerve block.
Local infiltration	Local infiltration	Patients in this group will receive the standard method of local infiltration of local anesthetic around the surgical site.

Primary Outcome Measures

Name	Time	Method
Postoperative pain	48 hours post-surgery	Pain will be recorded on a VAS scale immediately following surgery and then 24 and 48 hours post-surgery.

Secondary Outcome Measures

Name	Time	Method
Chronic pain	6 months post-surgery	All patients will be interviewed 3 and 6 months following the surgery in our chronic pain clinic or on the phone to evaluate the incidence of chronic groin pain in both groups.
Analgesic consumption	48 hours post-surgery	Consumption of all opioidal and non-opioidal analgesics will be recorded during the 48-hour period after surgery.

Trial Locations

Locations (1)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada