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…
ID
Bron
Verkorte titel
Aandoening
Inguinal Pain
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Change on pain score (Surgical Pain Scales and McGill Pain Questionnaire - Dutch Language Version).
Achtergrond van het onderzoek
Chronic 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.
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
Neurectomy 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.
Publiek
R.M.H. Roumen
De Run 4600
Veldhoven 5500 MB
The Netherlands
+31 (0)40 8888000
R.Roumen@mmc.nl
Wetenschappelijk
R.M.H. Roumen
De Run 4600
Veldhoven 5500 MB
The Netherlands
+31 (0)40 8888000
R.Roumen@mmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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 Lidocain;
2. Corrected inguinal hernia;
3. Inguinal pain > 3 months;
4. Age of 18 yrs or older;
5. Adequate follow-up possible.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Presence of inguinal hernia recurrence;
2. Local inguinal inflammatory signs;
3. Patient classified as American Society of Anaesthesiologist Class 3 or more.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL801 |
NTR-old | NTR814 |
Ander register | : N/A |
ISRCTN | ISRCTN93771787 |