Polyamine Deficient Diet
OtherDiet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet
NCT Number: NCT04219956
The aim of this study is to evaluate if a polyamine deficient diet started 7 days prior to a major abdominal surgery (eventration cure and digestive continuity) and followed 7 days post-surgery reduces the area under the curve of the numerical pain rating scale in the 72 hours post-surgery.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
CHRU Brest La Cavale Blanche, Brest, France
Morphine derivatives are known to be a major cause of postoperative ileus and also operative hyperalgesia. Operative hyperalgesia corresponds to an increase in morphine needs postoperatively which is proportional to the morphine dose necessary during the surgery. This effect is due to two mechanisms: opioids tolerance and induced hypersensitivity.
N-methyl-D-aspartate receptors (R-NMDA) play a key role in this induced hypersensitivity. Polyamines, organic compounds with several amines functions, are known R-NMDA agonists. They increase the phosphorylation of the tyrosine group within the NR2B subunit responsible for the inflammatory hyperalgesia.
Limiting the binding of polyamines to the R-NMDA seems an easy, safe and efficient way to limit the hypersensitivity induced post-operatively.
Most of the polyamines in the human body come from food. One study listed food regarding their polyamines content and allowed to check the safety of a polyamine deficient diet. Such a well-followed diet would allow to reduce by 20 the polyamines quantity present in the body.
The aim of this study is to evaluate whether a deficient polyamine diet introduced 7 days before and continued up to 7 days after an abdominal surgery requiring the use of morphine post-operatively reduces the post-operative pain, the consumption of analgesics (morphine) post-operatively and improve the recovery ability. Abdominals surgeries concerned will be the eventration cure and digestive continuity.
The medico-economic impact will be observed during this study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet
Time frame: 72 hours post-surgery
To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group measured every 6 hours in resting position, upon return from the operative room
Time frame: 15 days post-surgery
Measure of the analgesics consumption by the nurse during hospitalisation and by the patient with the patient book up to 15 days postsurgery
Time frame: 6 months post-surgery
Evaluation of the main dimension of pain using the Brief Pain Inventory (BPI)
Time frame: 6 months post-surgery
Evaluation of the time to recover the gas transit post-surgery (in days)
Time frame: 6 months post-surgery
Recovery of spontaneous urination post-surgery (in days)
Time frame: 6 months post-surgery
Time before walking post-surgery (in days)
Time frame: 6 months post-surgery
Hospitalisation time and sick leave (in days)
Time frame: 6 months post-surgery
Use of the Neuropathic pain scale for patients seen for their postsurgery pain or complications. The scale contains 10 questions, the range is between 0-10, 10 being the worst score.
Time frame: 1 month before surgery, 1 month and 6 months post-surgery
Use of autoquestionnaire EuroQol-5 Dimension (EQ-5D) to evaluate the global health status of the patients. The scale contains two parts, the first one contains 5 items to be completed by the patients with 5 levels for each item, the worst score being 55555. The second part is an analog visual scale with a range between 0-100, 0 being the worst score.
Time frame: 1 month before surgery, 1 month and 6 months post-surgery
Evaluation of the recovery ability using the Quality of Recovery-15 Questionnaire (QoR-15)
Time frame: 1 month before surgery, 1 month and 6 months post-surgery
Assessment of the patient's quality of life by using the Short-Form Health Survey 36 questionnaire (SF-36)
Contact information is provided by the study sponsor or research team.
Claire Blanchard, MD-PhD
CONTACT
Laetitia Berly
CONTACT
Nantes University Hospital
Other
A Prospective Randomized Multicenter Study to Evaluate the Efficacy of a Polyamine-deficient Diet for the Treatment of Postoperative Pain After Abdominal Surgery.
Acronym: POLYAMAL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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