GaPP: Gabapentin for Pelvic Pain

• Research type

  Research Study

• Full title

  GaPP: A pilot randomised controlled trial of the efficacy and mechanism of action of gabapentin for the management of chronic pelvic pain in women.

• IRAS ID

  97998

• Contact name

  Andrew Horne

• Sponsor organisation

  University of Edinburgh

• Eudract number

  2011-005494-22

• Research summary

  Chronic pelvic pain (CPP) affects >1 million UK women. Annual healthcare costs are estimated at >150 million. Proven interventions for CPP are limited and treatment is often unsatisfactory. Gabapentin is increasingly prescribed due to reports of effectiveness in other chronic pain conditions but there are insufficient data supporting value in CPP specifically. The mechanism of action of gabapentin in CPP is also unclear. Given the prevalence and costs of CPP, we believe a large multi-centre placebo-controlled double-blind randomised-controlled trial (RCT) to evaluate the efficacy of gabapentin in management of CPP is required along with exploration of its mechanism of action. The focus of this study is a pilot to inform planning of a future RCT. We aim to recruit 60 women with CPP in NHS Lothian and NHS Grampian and randomise them to gabapentin or placebo. Response to treatment will be monitored by questionnaire at 3 and 6 months. A random subset of 20 Edinburgh women will undergo functional magnetic resonance imaging of the brain prior to treatment and at 3 months. Our primary objective is to assess recruitment and retention rates and to obtain data to refine the research methodology for the RCT. We also aim to perform a pre-trial cost-effectiveness assessment of treatment with gabapentin.

• REC name

  Scotland A REC

• REC reference

  12/SS/0005

• Date of REC Opinion

  31 Jan 2012

• REC opinion

  Favourable Opinion