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US-guided Ilioinguinal Blocks Versus Local Infiltration

Primary Purpose

Pain, Postoperative

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ilioinguinal block
Local infiltration
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alberta Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ilioinguinal block

Local infiltration

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Chronic pain
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
Consumption of all opioidal and non-opioidal analgesics will be recorded during the 48-hour period after surgery.

Full Information

First Posted
June 3, 2013
Last Updated
March 23, 2020
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT01871181
Brief Title
US-guided Ilioinguinal Blocks Versus Local Infiltration
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
PI no longer at institution
Study Start Date
May 2013 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ilioinguinal block
Arm Type
Experimental
Arm Description
Patients in this group will receive an ultrasound-guided ilioinguinal nerve block.
Arm Title
Local infiltration
Arm Type
Active Comparator
Arm Description
Patients in this group will receive the standard method of local infiltration of local anesthetic around the surgical site.
Intervention Type
Procedure
Intervention Name(s)
Ilioinguinal block
Intervention Description
0.25% bupivacaine will be administered on a mg/kg basis
Intervention Type
Procedure
Intervention Name(s)
Local infiltration
Intervention Description
Surgeon will infiltrate incision area with local anesthetic before closure.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Pain will be recorded on a VAS scale immediately following surgery and then 24 and 48 hours post-surgery.
Time Frame
48 hours post-surgery
Secondary Outcome Measure Information:
Title
Chronic pain
Description
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.
Time Frame
6 months post-surgery
Title
Analgesic consumption
Description
Consumption of all opioidal and non-opioidal analgesics will be recorded during the 48-hour period after surgery.
Time Frame
48 hours post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21509811
Citation
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.
Results Reference
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PubMed Identifier
19707710
Citation
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.
Results Reference
background
PubMed Identifier
15695545
Citation
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.
Results Reference
background
PubMed Identifier
19627532
Citation
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.
Results Reference
background
PubMed Identifier
18482237
Citation
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.
Results Reference
background
PubMed Identifier
16466114
Citation
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.
Results Reference
background
PubMed Identifier
19040739
Citation
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.
Results Reference
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US-guided Ilioinguinal Blocks Versus Local Infiltration

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