Effectiveness, cost-effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: protocol of a placebo controlled randomised controlled trial with blinding (GAP study)
Introduction Gabapentin is an antiepileptic drug currently licensed to treat epilepsy and neuropathic pain but has been used off-label to treat acute postoperative pain. The GAP study will compare the effectiveness, cost-effectiveness and safety of gabapentin as an adjunct to standard multimodal ana...
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| Language: | English |
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BMJ Publishing Group
2020-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/11/e041176.full |
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| author | Chris A Rogers Lucy Culliford Maria Pufulete Sarah Baos Mark Edwards Sarah Wordsworth Elizabeth A Stokes Holly Mckeon Gianluca Casali Aiman Alzetani Reyad Abbadi Nilesh Chauhan Laura Collett Samantha E de Jesus Nicholas Goddard Jennifer Lamb Mat Molyneux Ben Gibbison |
| author_facet | Chris A Rogers Lucy Culliford Maria Pufulete Sarah Baos Mark Edwards Sarah Wordsworth Elizabeth A Stokes Holly Mckeon Gianluca Casali Aiman Alzetani Reyad Abbadi Nilesh Chauhan Laura Collett Samantha E de Jesus Nicholas Goddard Jennifer Lamb Mat Molyneux Ben Gibbison |
| author_sort | Chris A Rogers |
| collection | DOAJ |
| description | Introduction Gabapentin is an antiepileptic drug currently licensed to treat epilepsy and neuropathic pain but has been used off-label to treat acute postoperative pain. The GAP study will compare the effectiveness, cost-effectiveness and safety of gabapentin as an adjunct to standard multimodal analgesia versus placebo for the management of pain after major surgery.Methods and analysis The GAP study is a multicentre, double-blind, randomised controlled trial in patients aged 18 years and over, undergoing different types of major surgery (cardiac, thoracic or abdominal). Patients will be randomised in a 1:1 ratio to receive either gabapentin (600 mg just before surgery and 600 mg/day for 2 days after surgery) or placebo in addition to usual pain management for each type of surgery. Patients will be followed up daily until hospital discharge and then at 4 weeks and 4 months after surgery. The primary outcome is length of hospital stay following surgery. Secondary outcomes include pain, total opioid use, adverse health events, health related quality of life and costs.Ethics and dissemination This study has been approved by the Research Ethics Committee . Findings will be shared with participating hospitals and disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. Patients will be informed of the results through patient organisations and participant newsletters.Trial registration number ISRCTN63614165. |
| format | Article |
| id | doaj-art-53762aa9daee4bf0aab0c086e2c75789 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-53762aa9daee4bf0aab0c086e2c757892025-08-20T01:53:36ZengBMJ Publishing GroupBMJ Open2044-60552020-11-01101110.1136/bmjopen-2020-041176Effectiveness, cost-effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: protocol of a placebo controlled randomised controlled trial with blinding (GAP study)Chris A Rogers0Lucy Culliford1Maria Pufulete2Sarah Baos3Mark Edwards4Sarah Wordsworth5Elizabeth A Stokes6Holly Mckeon7Gianluca Casali8Aiman Alzetani9Reyad Abbadi10Nilesh Chauhan11Laura Collett12Samantha E de Jesus13Nicholas Goddard14Jennifer Lamb15Mat Molyneux16Ben Gibbison17Bristol Trials Centre, University of Bristol, Bristol, UK1 Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK9 Bristol Heart Institute, Bristol Medical School, University of Bristol, Bristol, UKBristol Trials Centre, University of Bristol, Bristol, UKNeuropsychiatry Research and Education Group, Institute of Psychiatry Psychology & Neuroscience, King`s College London, London, UKHealth Economics Research Centre, Nuffield Department of Population Health, National Institute for Health Research Oxford Biomedical Research Centre, University of Oxford, Oxford, Oxfordshire, UKHealth Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UKBristol Trials Centre, Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol, UKDepartment of Surgery, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK4 Southampton University Hospitals NHS Trust, Southampton, UKDepartment of Surgery, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UKDepartment of Anaesthesia, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UKBristol Trials Centre, Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol, UKBristol Trials Centre, Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol, UKDepartment of Anaesthesia, University Hospital Southampton NHS FoundationTrust, Southampton, UKBristol Trials Centre, Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol, UKDepartment of Anaesthesia, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK3 Cardiac Anaesthesia and Intensive Care, Bristol Medical School, University of Bristol, Bristol, UKIntroduction Gabapentin is an antiepileptic drug currently licensed to treat epilepsy and neuropathic pain but has been used off-label to treat acute postoperative pain. The GAP study will compare the effectiveness, cost-effectiveness and safety of gabapentin as an adjunct to standard multimodal analgesia versus placebo for the management of pain after major surgery.Methods and analysis The GAP study is a multicentre, double-blind, randomised controlled trial in patients aged 18 years and over, undergoing different types of major surgery (cardiac, thoracic or abdominal). Patients will be randomised in a 1:1 ratio to receive either gabapentin (600 mg just before surgery and 600 mg/day for 2 days after surgery) or placebo in addition to usual pain management for each type of surgery. Patients will be followed up daily until hospital discharge and then at 4 weeks and 4 months after surgery. The primary outcome is length of hospital stay following surgery. Secondary outcomes include pain, total opioid use, adverse health events, health related quality of life and costs.Ethics and dissemination This study has been approved by the Research Ethics Committee . Findings will be shared with participating hospitals and disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. Patients will be informed of the results through patient organisations and participant newsletters.Trial registration number ISRCTN63614165.https://bmjopen.bmj.com/content/10/11/e041176.full |
| spellingShingle | Chris A Rogers Lucy Culliford Maria Pufulete Sarah Baos Mark Edwards Sarah Wordsworth Elizabeth A Stokes Holly Mckeon Gianluca Casali Aiman Alzetani Reyad Abbadi Nilesh Chauhan Laura Collett Samantha E de Jesus Nicholas Goddard Jennifer Lamb Mat Molyneux Ben Gibbison Effectiveness, cost-effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: protocol of a placebo controlled randomised controlled trial with blinding (GAP study) BMJ Open |
| title | Effectiveness, cost-effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: protocol of a placebo controlled randomised controlled trial with blinding (GAP study) |
| title_full | Effectiveness, cost-effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: protocol of a placebo controlled randomised controlled trial with blinding (GAP study) |
| title_fullStr | Effectiveness, cost-effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: protocol of a placebo controlled randomised controlled trial with blinding (GAP study) |
| title_full_unstemmed | Effectiveness, cost-effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: protocol of a placebo controlled randomised controlled trial with blinding (GAP study) |
| title_short | Effectiveness, cost-effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: protocol of a placebo controlled randomised controlled trial with blinding (GAP study) |
| title_sort | effectiveness cost effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients protocol of a placebo controlled randomised controlled trial with blinding gap study |
| url | https://bmjopen.bmj.com/content/10/11/e041176.full |
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