NCT01373593

Brief Summary

In this controlled study the investigators will examine the analgesic and sensory effects of ultrasound-guided blocks of the iliohypogastric and ilioinguinal nerves with lidocaine in persistent postherniorrhaphy pain patients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_4 pain

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

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

June 20, 2012

Status Verified

January 1, 2011

Enrollment Period

6 months

First QC Date

June 8, 2011

Last Update Submit

June 19, 2012

Conditions

Pain

Keywords

persistent postherniorrhaphy pain

Outcome Measures

Primary Outcomes (1)

  • changes (lidocaine vs. placebo) in pain perception, sensory mapping and QST compared to pre-block values.

    20 minutes after the block

Study Arms (2)

lidocaine

EXPERIMENTAL

lidocaine block

Drug: lidocaine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

lidocaineDRUG
lidocaine
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • patients older than 18 years with severe postherniorrhaphy pain (numerical rating scale \[NRS\] \> 6) for more than 6 month

You may not qualify if:

  • known amide local anesthetic drug allergy
  • recurrent hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

  • Bischoff JM, Koscielniak-Nielsen ZJ, Kehlet H, Werner MU. Ultrasound-guided ilioinguinal/iliohypogastric nerve blocks for persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled, crossover trial. Anesth Analg. 2012 Jun;114(6):1323-9. doi: 10.1213/ANE.0b013e31824d6168. Epub 2012 Mar 30.

    PMID: 22467891DERIVED

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 15, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

June 20, 2012

Record last verified: 2011-01

Locations

DK(1)