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Recruiting Not applicable

Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery

NCT04219956 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-02-03
Last updated
2025-11-14

Condition(s) studied

Digestive System Surgical Procedures

Investigational drug(s) / intervention(s)

Polyamine Deficient Diet

Polyamine Deficient Diet: Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 — 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

Trial sites (4)

FacilityCityRegionStatus
CHRU Brest La Cavale Blanche Brest France Recruiting
Hôpital Louis Mourier from Ap-HP Colombes France Recruiting
CHD Vendée La Roche-sur-Yon France Recruiting
CHU Nantes Hôtel Dieu Nantes France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04219956 on ClinicalTrials.gov ↗ ← All trials in France