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
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