A prospective, randomised, placebo-controlled, blinded trial of gabapentin in chronic groin pain following groin hernia repair
| ISRCTN | ISRCTN43433116 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43433116 |
| Protocol serial number | N0185109366 |
| Sponsor | Department of Health (UK) |
| Funder | Plymouth Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 11/01/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr AK Dashfield
Scientific
Scientific
Anaesthetic Department
Level 04
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom
| Phone | +44 (0)1752 777111 |
|---|---|
| adrian.dashfield@phnt.swest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo-controlled blinded trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Patients will be randomised into two groups who present with chronic inguinodynia - gabapentin or placebo. A preliminary questionnaire will be administered and pain scores will be recorded. Patients will be supplied with either gabapentin or placebo in an increasing dose. Patients will be followed up at 4 weeks post treatment where questionnaires and pain scores will be repeated as well as perceived side effects of the treatment recorded. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
| Intervention | Patients will be randomised into two groups who present with chronic inguinodynia - gabapentin or placebo. A preliminary questionnaire will be administered and pain scores will be recorded. Patients will be supplied with either gabapentin or placebo in an increasing dose. Patients will be followed up at 4 weeks post treatment where questionnaires and pain scores will be repeated as well as perceived side effects of the treatment recorded. Added 11/01/2010: trial stopped due to lack of funding |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | gabapentin |
| Primary outcome measure(s) |
That gabapentin, an anticonvulsant drug used in the treatment of neuropathic pain, significantly reduces pain in patients with inguinodynia. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2004 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Anaesthetic Department
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
