Condition category
Signs and Symptoms
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
16/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R M H Roumen

ORCID ID

Contact details

Maxima Medical Center
Department of Surgery
P.O. Box 7777
Veldhoven
5500 MB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The pain reductive effect of a neurectomy of the ilio-inguinal, ilio-hypogastric or/and genital branch of the genito-femoral nerve(s) is significantly more compared to an injection with lidocain, corticosteroids and hyaluronic acid for neuropathic groin pain syndrome.

Ethics approval

Approval received from the Medical Ethics Board Maxima Medical Centre on the 1st May 2006 (ref: 0543).

Study design

Randomised, controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Inguinal Pain

Intervention

Neurectomy of ilio-inguinal, ilio-hypogastric or/and genital branch of the genito-femoral nerve(s) compared with an injection with lidocaine, corticosteroids and hyaluronic acid on postherniorrhaphy inguinodynia.

Intervention type

Drug

Phase

Not Specified

Drug names

Lidocaine, corticosteroids and hyaluronic acid

Primary outcome measures

Change on pain score (Surgical Pain Scales and McGill Pain Questionnaire - Dutch Language Version).

Secondary outcome measures

1. Complications
2. Alterations in inguinal neurophysiological status (Leeds Assessment of Neuropathic Symptoms and Signs [LANNS] pain scale)
3. Quality of life (Short Form health survey [SF-36] version II)
4. Change in employment status

Overall trial start date

01/02/2006

Overall trial end date

01/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Nerve entrapment or damage of ilio-inguinal, ilio-hypogastric or/ and genital branch of the genito;-femoral nerve(s) confirmed with peripheral nerve blockade with Lidocaine
2. Corrected inguinal hernia
3. Inguinal pain more than three months
4. Age of 18 yrs or older
5. Adequate follow-up possible

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

54

Participant exclusion criteria

1. Presence of inguinal hernia recurrence
2. Local inguinal inflammatory signs
3. Patient classified as American Society of Anaesthesiologist Class three or more

Recruitment start date

01/02/2006

Recruitment end date

01/02/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Maxima Medical Center
Veldhoven
5500 MB
Netherlands

Sponsor information

Organisation

Maxima Medical Center (The Netherlands)

Sponsor details

Department of General Surgery
P.O. Box 7777
Veldhoven
5500 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

MÁxima Medical Center (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes