Evaluating a diet low in polyamines to reduce postoperative pain after abdominal surgery
Official title: A Prospective Randomized Multicenter Study to Evaluate the Efficacy of a Polyamine-deficient Diet for the Treatment of Postoperative Pain After Abdominal Surgery.
Run by Nantes University Hospital · NCT04219956 · Data updated 2026-11-12
This study is testing if a special diet low in polyamines can help people having major abdominal surgery feel less pain and need less morphine after their operation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 278 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 4 sites (Brest and 3 other locations) |
| Status | Recruiting |
| Started | February 3, 2020 |
| Main results expected | April 2027 |
| Study ends | November 2027 |
| Registry record updated | November 14, 2025 |
| Trial ID | NCT04219956 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years scheduled for major abdominal surgery requiring postoperative morphine.
✕Probably not a fit
Patients undergoing non-painful surgeries or those with chronic pain conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to determine if a polyamine-deficient diet, initiated seven days before and continued for seven days after major abdominal surgery, can reduce postoperative pain and the need for morphine. The research focuses on patients undergoing eventration cure and digestive continuity procedures. By limiting polyamines, which are known to contribute to hypersensitivity and increased pain perception, the study seeks to improve recovery outcomes and reduce analgesic consumption. Participants will be monitored for pain levels and recovery over a follow-up period of seven months.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and reliance on opioids for patients undergoing major abdominal surgeries.
How similar studies have gone: While the specific approach of a polyamine-deficient diet is novel, similar dietary interventions have shown promise in managing postoperative pain in other contexts.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
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
Study contacts
- Principal investigator: Claire Blanchard, MD-PhD — Nantes University Hospital
- Study coordinator: Claire Blanchard, MD-PhD
- Email: claire.blanchard@chu-nantes.fr
- Phone: +33 (0)2 40 08 30 22
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.