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
Secondary identifying numbers	N0185109366

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

Anaesthetic Department
Level 04
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom

Phone	+44 (0)1752 777111
Email	adrian.dashfield@phnt.swest.nhs.uk

Study information

Study design	Randomised placebo-controlled blinded trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	gabapentin
Primary outcome measure	That gabapentin, an anticonvulsant drug used in the treatment of neuropathic pain, significantly reduces pain in patients with inguinodynia.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2004
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
Target number of participants	Not provided at time of registration
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

England
United Kingdom

Study participating centre

Anaesthetic Department

Plymouth
PL6 8DH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Plymouth Hospitals NHS Trust (UK)

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