Overview

This trial is active, not recruiting.

Condition pain, postoperative
Treatments ilioinguinal block, local infiltration
Sponsor University of Alberta
Start date May 2013
End date January 2017
Trial size 60 participants
Trial identifier NCT01871181, Pro00026522

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Patients in this group will receive an ultrasound-guided ilioinguinal nerve block.
ilioinguinal block
0.25% bupivacaine will be administered on a mg/kg basis
(Active Comparator)
Patients in this group will receive the standard method of local infiltration of local anesthetic around the surgical site.
local infiltration
Surgeon will infiltrate incision area with local anesthetic before closure.

Primary Outcomes

Measure
Postoperative pain
time frame: 48 hours post-surgery

Secondary Outcomes

Measure
Chronic pain
time frame: 6 months post-surgery
Analgesic consumption
time frame: 48 hours post-surgery

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title The Short and Long-term Effects of Ultrasound-guided Ilioinguinal and Iliohypogastric Nerve Block on Postoperative Pain Control Following Open Inguinal Hernia Repair
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Alberta.