| - candidate number | 2295 |
| - NTR Number | NTR814 |
| - ISRCTN | ISRCTN93771787 |
| - Date ISRCTN created | 28-dec-2006 |
| - date ISRCTN requested | 18-dec-2006 |
| - Date Registered NTR | 23-okt-2006 |
| - Secondary IDs | N/A |
| - Public Title | GroinPain Trial: the effect of a neurectomy compared with an injection with lidocain, corticosteroids and hyaluronic acid on postherniorrhaphy inguinodynia. |
| - Scientific Title | GroinPain Trial: the effect of a neurectomy compared with an injection with lidocain, corticosteroids and hyaluronic acid on postherniorrhaphy inguinodynia. |
| - ACRONYM | N/A |
| - 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. |
| - Healt Condition(s) or Problem(s) studied | Inguinal Pain |
| - 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 Lidocain; 2. Corrected inguinal hernia; 3. Inguinal pain > 3 months; 4. Age of 18 yrs or older; 5. Adequate follow-up possible. |
| - Exclusion criteria | 1. Presence of inguinal hernia recurrence; 2. Local inguinal inflammatory signs; 3. Patient classified as American Society of Anaesthesiologist Class 3 or more. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-feb-2006 |
| - planned closingdate | 1-feb-2008 |
| - Target number of participants | 54 |
| - Interventions | 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. |
| - Primary outcome | Change on pain score (Surgical Pain Scales and McGill Pain Questionnaire - Dutch Language Version). |
| - Secondary outcome | 1. 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 site | N/A |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | Dr. R.M.H. Roumen |
| - CONTACT for SCIENTIFIC QUERIES | Drs 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 |
| - Publications | N/A |
| - Brief summary | 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. |
| - Main changes (audit trail) | |
| - RECORD | 23-okt-2006 - 31-dec-2006 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl