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  • GaPP: a pilot randomised controlled trial of the efficacy of action of gabapentin for the management of chronic pelvic pain in women: study protocol

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Reproductive medicine, obstetrics and gynaecology
Protocol
GaPP: a pilot randomised controlled trial of the efficacy of action of gabapentin for the management of chronic pelvic pain in women: study protocol
  1. Andrew W Horne1,
  2. Hilary O D Critchley1,
  3. Ann Doust1,
  4. Daniel Fehr2,
  5. John Wilson3,
  6. Olivia Wu4,
  7. S Jack5,
  8. Maureen Porter6,
  9. Steff Lewis7,
  10. Siladitya Bhattacharya6
  1. 1MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK
  2. 2Universitäres Interdisziplinäres Kinderwunschzentrum Düsseldorf, Düsseldorf, Germany
  3. 3Department of Anaesthesia, Royal Infirmary of Edinburgh, Edinburgh, UK
  4. 4Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
  5. 5Department of Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK
  6. 6Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK
  7. 7Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK
  1. Correspondence to Dr Andrew Horne; andrew.horne{at}ed.ac.uk

Abstract

Introduction 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 by which gabapentin exerts its analgesic action is unknown. Given the prevalence and costs of CPP, the authors believe that a large, multicentre, placebo-controlled, double-blind randomised controlled trial to evaluate the efficacy of gabapentin in management of CPP is required. The focus of this study is a pilot to inform planning of a future randomised controlled trial.

Methods and analysis The authors plan to perform a two-arm, parallel, randomised controlled pilot trial. The authors aim to recruit 60 women with CPP in NHS Lothian and NHS Grampian (UK) and randomise them to gabapentin or placebo. Response to treatment will be monitored by questionnaire compared at 0, 3 and 6 months. The primary objective is to assess recruitment and retention rates. The secondary objectives are to determine the effectiveness and acceptability to participants of the proposed methods of recruitment, randomisation, drug treatments and assessment tools and to perform a pretrial cost-effectiveness assessment of treatment with gabapentin.

Ethics and dissemination Ethical approval has been obtained from the Scotland A Research Ethics Committee (LREC 12/SS/0005). Data will be presented at international conferences and published in peer-reviewed journals.

Trial registration number ISRCTN70960777.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

https://doi.org/10.1136/bmjopen-2012-001297

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    Footnotes

    • To cite: Horne AW, Critchley HOD, Doust A, et al. GaPP: a pilot randomised controlled trial of the efficacy of action of gabapentin for the management of chronic pelvic pain in women: study protocol. BMJ Open 2012;2:e001297. doi:10.1136/bmjopen-2012-001297

    • Contributors AH: research, contribution of original material, editing and approval of final manuscript; HC, AD, DF, JW and SJ: contribution of original material, editing and approval of final manuscript; OW, MP, SL and SB: research, contribution of original material, editing and approval of final manuscript.

    • Funding This work is supported by a grant from the Chief Scientist's Office Scotland (CZH/4/688). AH is funded by an MRC Clinician Scientist Fellowship (G0802808). The funders and study sponsor will have no role in the study design; collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication.

    • Competing interests AH, HC, SJ, JW, SL, OW, MP and SB are all co-investigators on the grant from the Chief Scientist's Office Scotland (CZH/4/688) that has been secured to support this study. AH is funded by an MRC Clinician Scientist Fellowship (G0802808). HC holds an MRC Centre Grant (G1002033) and a project grant from Bayer Schering Pharma AG. AH and HC hold the University of Edinburgh Patent ‘Identification of Ectopic Pregnancies’ number 0712801.0.

    • Ethics approval Ethical approval has been obtained from the Scotland A Research Ethics Committee (LREC 12/SS/0005).

    • Provenance and peer review Not commissioned; internally peer reviewed.

    • Data sharing statement No additional data are available.