Post Operative Analgesia Clinical Trial
Official title:
Prospective, Controlled Versus Placebo, Randomized, Double-blind Study, Evaluating the Value of Non-opioid Analgesic Combination (Based on Paracetamol, Nefopam, Ketoprofen) for Postoperative Analgesia.
The combination of different analgesic drugs and/or analgesia techniques is part of the
standard management of postoperative analgesia. The analysis of the literature reveals a lack
of comparison of the associations of non-opioid analgesic (NOA) with morphine for
postoperative analgesia.
The objectives of this study are :
- comparing the morphine sparing effect of different combination of 3 NOA (paracetamol,
nefopam, ketoprofen) for postoperative analgesia.
- determining whether the morphine-sparing effect is associated with or without a
reduction in the incidence of morphine side effects.
- evaluating the effects of NOA on postoperative hyperalgesia.
Since the description of the concept of balanced analgesia in the early 90's, the combination
of different analgesic drugs and/or analgesia techniques is part of the standard management
of postoperative analgesia. A recent survey conducted in France by Fletcher et al. showed
that patients often received one or more NOA associated with an opioid. The benefit and risk
of the use of opioids associated with NOA were recently reassessed as part of a formal
recommendation of experts and detailed in a recent review. The analysis of the literature
reveals a lack of comparison of the combinations of NOA with morphine for postoperative
analgesia. For example, paracetamol and morphine in combination does not always allow a
significant morphine-sparing effect compared with morphine alone and does not reduce the
incidence of morphine side effects. A number of definitive answers has therefore yet to be
found: Does NOA -morphine association allow an effective morphine-sparing effect? Is there an
interest in prescribing several NOAs in association? If yes, what are the most interesting
combinations in terms of morphine-sparing effect and safety?
Another question concerns the effects of NOA on postoperative hyperalgesia. This
hyperalgesia, which results from surgery-related inflammation, is increased by consumption of
morphine and not only contributes to the overall experience of postoperative pain but also to
the chronicisation of postoperative pain. Since in clinical practice, hyperalgesia can be
measured using specific tools (Von Frey filament type), our study will evaluate the
anti-hyperalgesic effects of NOA on a subgroup of patients enrolled in the centers used to
evaluate nociceptive thresholds.
The objectives of this study are :
- comparing the morphine sparing effect of different combination of 3 NOA (paracetamol,
nefopam, ketoprofen) for postoperative analgesia.
- determining whether the morphine-sparing effect is associated with or without a
reduction in the incidence of morphine side effects.
- evaluating the effects of NOA on postoperative hyperalgesia.
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