Preventive effect of oral magnesium in postmastectomy pain: protocol for a randomised, double-blind, controlled clinical trial
Morel V, Joly D, Villatte C, Pereira B, Pickering G
BMJ open · 7 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2018-09-01 · BMJ Open · vol. 8 · issue 9 · p. e017986
- Publisher
- BMJ
- Cited
- 11 citations · more than 82% of similar papers · 1.3× the field average
- References
- 70 works
- Access
- Open access (journal) · CC-BY-NC
- Research areas
- Music Therapy and Health · Pain Management and Opioid Use · Cancer-related cognitive impairment studies
- Keywords
- Medicine, Quality of life (healthcare), Neuropathic pain, Placebo, Clinical trial, Mastectomy, Randomized controlled trial, Analgesic, Breast cancer, Physical therapy, Anesthesia, Cancer, Internal medicine, Alternative medicine, Nursing
- MeSH
- humans, breast neoplasms, neuralgia, magnesium, receptors, n-methyl-d-aspartate, mastectomy, administration, oral, double-blind method, depression, emotions, anxiety, cognition, psychiatric status rating scales, trail making test, quality of life, female, randomized controlled trials as topic, postoperative pain
5 authors
From FR
- Véronique Morel · correspondingInserm; Centre Hospitalier Universitaire de Clermont-Ferrand
- Dominique JolyCentre Jean Perrin
- Christine VillatteCentre Jean Perrin
- Bruno Pereira
- Gisele P PickeringInserm; Université Clermont Auvergne; Physiopathologie et pharmacologie de la douleur et de la migraine; Centre Hospitalier Universitaire de Clermont-Ferrand
Abstract
Introduction
Breast cancer affects 1 in 10 women worldwide, and mastectomy is a cause of chronic pain with neuropathic characteristics. N-methyl-D-aspartate receptor (NMDAR) antagonists such as ketamine, memantine, dextromethorphan or magnesium are used to treat refractory pain by blocking NMDAR. Oral memantine has been shown to prevent postmastectomy pain and cognitive impact and to maintain quality of life. Likewise, the present study is intended to assess the preventive effect of oral magnesium, administered ahead of mastectomy, on the development of neuropathic pain. As a physiological blocker of NMDAR, magnesium could be an interesting candidate to prevent postoperative pain and associated comorbidities, including cognitive and emotional disorders, multiple analgesic consumption and impaired quality of life.
Methods and analysis
A randomised double-blind controlled clinical trial (NCT03063931) will include 100 women with breast cancer undergoing mastectomy at the Oncology Hospital, Clermont-Ferrand, France. Magnesium (100 mg/day; n=50) or placebo (n=50) will be administered for 6 weeks, starting 2 weeks before surgery. Intensity of pain, cognitive and emotional function and quality of life will be assessed by questionnaires. The primary endpoint is pain intensity on a 0-10 numerical rating scale at 1 month postmastectomy. Data analysis will use mixed models; all tests will be two-tailed, with type-I error set at α=0.05.
Ethics and dissemination
The study protocol and informed consent form were approved in December 2016 by the French Research Ethics Committee (South East VI Committee). Results will be communicated in various congresses and published in international publications.
Trial registration number
NCT03063931.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC).
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