Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery
A Prospective Randomized Multicenter Study to Evaluate the Efficacy of a Polyamine-deficient Diet for the Treatment of Postoperative Pain After Abdominal Surgery.
Nantes University Hospital
278 participants
Feb 3, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria14
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04219956