Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain Afte… (NCT04219956) | Clinical Trial Compass
RecruitingNot Applicable
Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery
France278 participantsStarted 2020-02-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult (\>18 years)
* Indication for a " major " abdominal surgery as second surgical procedure : cure of eventration and restoration of digestive continuity
* Intended Use of a Patient Controlled Morphine Pump (PCA) postoperatively or taking oral opioids
* Possible follow-up during 7 months (post-operative consultation at 1 month and 6 months only if postoperative pain or complications)
* Written informed consent form obtained from the patient
* Affiliated to the social security
Exclusion Criteria:
* Pregnant women
* Minor, adult under guardianship or benefiting from a legal protection
* Oncological surgery
* Surgery not painful (cholecystectomy, hernia, thyroidectomy, bariatric surgery)
* Drug addicts patients, or under opiate dependency
* Chronic pain patients (pain over 3 months)
* Patients in nursing home or convalescence home (diet non possible in institution)
* Planned hospitalisation before the intervention (during the 7 days before the surgery)
* Severe undernutrition defined by the HAS criteria (weight loss \> 10% in 1 month and/or \> 15% in 6 months, albumin at inclusion \<15g/l)
* Patient refusing the possibility to change his eating habits
* Oral feeding impossible preoperatively
* Patient not able to express himself on their pain (silent, …)
* Decompensated psychiatric pathologies (severe depression syndrome,…)
* Patient unable to understand the protocol and/or to give his informed consent
What they're measuring
1
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