NCT01871181

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 25, 2020

Status Verified

October 1, 2016

Enrollment Period

4.5 years

First QC Date

June 3, 2013

Last Update Submit

March 23, 2020

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

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

    48 hours post-surgery

Secondary Outcomes (2)

  • Chronic pain

    6 months post-surgery

  • Analgesic consumption

    48 hours post-surgery

Study Arms (2)

Ilioinguinal block

EXPERIMENTAL

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

Procedure: Ilioinguinal block

Local infiltration

ACTIVE COMPARATOR

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

Procedure: Local infiltration

Interventions

Ilioinguinal blockPROCEDURE

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

Ilioinguinal block
Local infiltrationPROCEDURE

Surgeon will infiltrate incision area with local anesthetic before closure.

Local infiltration

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-3
  • Both gender
  • years and older
  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2G3, Canada

Location

Related Publications (7)

  • 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.

    PMID: 21509811BACKGROUND

  • 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.

    PMID: 19707710BACKGROUND

  • 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.

    PMID: 15695545BACKGROUND

  • 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.

    PMID: 19627532BACKGROUND

  • 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.

    PMID: 18482237BACKGROUND

  • 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.

    PMID: 16466114BACKGROUND

  • 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.

    PMID: 19040739BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 6, 2013

Study Start

May 1, 2013

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

March 25, 2020

Record last verified: 2016-10

Locations

CA(1)