US-guided Ilioinguinal Blocks Versus Local Infiltration
March 23, 2020 updated by: University of Alberta
The Short and Long-term Effects of Ultrasound-guided Ilioinguinal and Iliohypogastric Nerve Block on Postoperative Pain Control Following Open Inguinal Hernia Repair
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alberta
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Edmonton, Alberta, Canada, T6G 2G3
- University of Alberta Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ilioinguinal block
Patients in this group will receive an ultrasound-guided ilioinguinal nerve block.
|
0.25% bupivacaine will be administered on a mg/kg basis
|
|
Active Comparator: Local infiltration
Patients in this group will receive the standard method of local infiltration of local anesthetic around the surgical site.
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Surgeon will infiltrate incision area with local anesthetic before closure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain
Time Frame: 48 hours post-surgery
|
Pain will be recorded on a VAS scale immediately following surgery and then 24 and 48 hours post-surgery.
|
48 hours post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chronic pain
Time Frame: 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.
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6 months post-surgery
|
|
Analgesic consumption
Time Frame: 48 hours post-surgery
|
Consumption of all opioidal and non-opioidal analgesics will be recorded during the 48-hour period after surgery.
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48 hours post-surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jagannathan N, Sohn L, Sawardekar A, Ambrosy A, Hagerty J, Chin A, Barsness K, Suresh S. Unilateral groin surgery in children: will the addition of an ultrasound-guided ilioinguinal nerve block enhance the duration of analgesia of a single-shot caudal block? Paediatr Anaesth. 2009 Sep;19(9):892-8. doi: 10.1111/j.1460-9592.2009.03092.x. Epub 2009 Jul 13.
- Klaassen Z, Marshall E, Tubbs RS, Louis RG Jr, Wartmann CT, Loukas M. Anatomy of the ilioinguinal and iliohypogastric nerves with observations of their spinal nerve contributions. Clin Anat. 2011 May;24(4):454-61. doi: 10.1002/ca.21098. Epub 2011 Jan 3.
- Ndiaye A, Diop M, Ndoye JM, Ndiaye A, Mane L, Nazarian S, Dia A. Emergence and distribution of the ilioinguinal nerve in the inguinal region: applications to the ilioinguinal anaesthetic block (about 100 dissections). Surg Radiol Anat. 2010 Jan;32(1):55-62. doi: 10.1007/s00276-009-0549-0. Epub 2009 Aug 26.
- Andersen FH, Nielsen K, Kehlet H. Combined ilioinguinal blockade and local infiltration anaesthesia for groin hernia repair--a double-blind randomized study. Br J Anaesth. 2005 Apr;94(4):520-3. doi: 10.1093/bja/aei083. Epub 2005 Feb 4.
- Suresh S, Patel A, Porfyris S, Ryee MY. Ultrasound-guided serial ilioinguinal nerve blocks for management of chronic groin pain secondary to ilioinguinal neuralgia in adolescents. Paediatr Anaesth. 2008 Aug;18(8):775-8. doi: 10.1111/j.1460-9592.2008.02596.x.
- Wang H. Is ilioinguinal-iliohypogastric nerve block an underused anesthetic technique for inguinal herniorrhaphy? South Med J. 2006 Jan;99(1):15. doi: 10.1097/01.smj.0000197300.37083.a8. No abstract available.
- Wehbe SA, Ghulmiyyah LM, Dominique el-KH, Hosford SL, Ehleben CM, Saltzman SL, Sills ES. Prospective randomized trial of iliohypogastric-ilioinguinal nerve block on post-operative morphine use after inpatient surgery of the female reproductive tract. J Negat Results Biomed. 2008 Nov 28;7:11. doi: 10.1186/1477-5751-7-11.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2013
Primary Completion (Actual)
November 1, 2017
Study Completion (Actual)
November 1, 2017
Study Registration Dates
First Submitted
June 3, 2013
First Submitted That Met QC Criteria
June 5, 2013
First Posted (Estimate)
June 6, 2013
Study Record Updates
Last Update Posted (Actual)
March 25, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00026522
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