GroinPain Trial: the effect of a neurectomy compared with an injection with lidocain, corticosteroids and hyaluronic acid on postherniorrhaphy inguinodynia
| ISRCTN | ISRCTN93771787 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93771787 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 26/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R M H Roumen
Scientific
Scientific
Maxima Medical Center
Department of Surgery
P.O. Box 7777
Veldhoven
5500 MB
Netherlands
Study information
| Study design | Randomised, controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | GroinPain Trial: the effect of a neurectomy compared with an injection with lidocain, corticosteroids and hyaluronic acid on postherniorrhaphy inguinodynia |
| Study objectives | 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(s) | Approval received from the Medical Ethics Board Maxima Medical Centre on the 1st May 2006 (ref: 0543). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lidocaine, corticosteroids and hyaluronic acid |
| Primary outcome measure | 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 study start date | 01/02/2006 |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 54 |
| Total final enrolment | 54 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 01/02/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Maxima Medical Center
Veldhoven
5500 MB
Netherlands
5500 MB
Netherlands
Sponsor information
Maxima Medical Center (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of General Surgery
P.O. Box 7777
Veldhoven
5500 MB
Netherlands
"ROR" |
https://ror.org/02x6rcb77 |
|---|
Funders
Funder type
Hospital/treatment centre
MÁxima Medical Center (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/05/2018 | 26/03/2021 | Yes | No |
Editorial Notes
26/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
