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GroinPain Trial: the effect of a neurectomy compared with an injection with lidocain, corticosteroids and hyaluronic acid on postherniorrhaphy inguinodynia.


- candidate number2295
- NTR NumberNTR814
- ISRCTNISRCTN93771787
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR23-okt-2006
- Secondary IDsN/A 
- Public TitleGroinPain Trial: the effect of a neurectomy compared with an injection with lidocain, corticosteroids and hyaluronic acid on postherniorrhaphy inguinodynia.
- Scientific TitleGroinPain Trial: the effect of a neurectomy compared with an injection with lidocain, corticosteroids and hyaluronic acid on postherniorrhaphy inguinodynia.
- ACRONYMN/A
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedInguinal Pain
- Inclusion criteria1. 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 Lidocain; 2. Corrected inguinal hernia; 3. Inguinal pain > 3 months; 4. Age of 18 yrs or older; 5. Adequate follow-up possible.
- Exclusion criteria1. Presence of inguinal hernia recurrence; 2. Local inguinal inflammatory signs; 3. Patient classified as American Society of Anaesthesiologist Class 3 or more.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-feb-2006
- planned closingdate1-feb-2008
- Target number of participants54
- InterventionsNeurectomy of ilio-inguinal, ilio-hypogastric or/ and genital branch of the genito-femoral nerve(s) compared with an injection with lidocain, corticosteroids and hyaluronic acid on postherniorrhaphy inguinodynia.
- Primary outcomeChange on pain score (Surgical Pain Scales and McGill Pain Questionnaire - Dutch Language Version).
- Secondary outcome1. Complications; 2. Alterations in inguinal neurophysiological status (LANNS pain scale); 3. Quality of life (SF-36 version II); 4. Change in employement status.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. R.M.H. Roumen
- CONTACT for SCIENTIFIC QUERIESDrs M.J.A. Loos
- Sponsor/Initiator Maxima Medical Center, Department of General Surgery
- Funding
(Source(s) of Monetary or Material Support)
Máxima Medical Center, Department of General Surgery
- PublicationsN/A
- Brief summaryChronic pain is a common complication after inguinal hernia repair (20-40%). In approximately 4% of patients, pain originates from entrapment or damage of the inguinal nerves. Previous retrospective research has showed surgical treatment, neurectomy, to be effective in 70-80% of these patients. However, current treatment by pain specialists comprises of injections with lidocain, corticosteroids and hyaluronic acid. To evaluate appropiate treatment for these neuropathic pain syndromes a randomised controlled trial was set up comparing these treatment modalities. We expect the surgical treatment to be more effective in reducing pain than injections (max 3 injections using a neurostimulator with a two-week interval). After six months patients in the injection-group are offered a cross-over to the surgical group. Statistical analysis: sample-size 2 groups of 27 patients, power 90%, type I error 0.05, intention-to-treat analysis. Primary outcome measure: pain reduction (Surgical Pain Scales, McGill Pain questionnaire - Dutch language version), Secondary outcomes: 1. complications, 2. neurophysiological changes (LANNS), 3. Quality of life (SF-36 version II), 4. Change in employement status.
- Main changes (audit trail)
- RECORD23-okt-2006 - 31-dec-2006


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