Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery
- Conditions
- Digestive System Surgical Procedures
- Registration Number
- NCT04219956
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 278
Inclusion Criteria:<br><br> - Adult (>18 years)<br><br> - Indication for a major abdominal surgery as second surgical procedure : cure of<br> eventration and restoration of digestive continuity<br><br> - Intended Use of a Patient Controlled Morphine Pump (PCA) postoperatively or taking<br> oral opioids<br><br> - Possible follow-up during 7 months (post-operative consultation at 1 month and 6<br> months only if postoperative pain or complications)<br><br> - Written informed consent form obtained from the patient<br><br> - Affiliated to the social security<br><br>Exclusion Criteria:<br><br> - Pregnant women<br><br> - Minor, adult under guardianship or benefiting from a legal protection<br><br> - Oncological surgery<br><br> - Surgery not painful (cholecystectomy, hernia, thyroidectomy, bariatric surgery)<br><br> - Drug addicts patients, or under opiate dependency<br><br> - Chronic pain patients (pain over 3 months)<br><br> - Patients in nursing home or convalescence home (diet non possible in institution)<br><br> - Planned hospitalisation before the intervention (during the 7 days before the<br> surgery)<br><br> - Severe undernutrition defined by the HAS criteria (weight loss > 10% in 1 month<br> and/or > 15% in 6 months, albumin at inclusion <15g/l)<br><br> - Patient refusing the possibility to change his eating habits<br><br> - Oral feeding impossible preoperatively<br><br> - Patient not able to express himself on their pain (silent, ...)<br><br> - Decompensated psychiatric pathologies (severe depression syndrome,...)<br><br> - Patient unable to understand the protocol and/or to give his informed consent
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Change in the analgesics consumption post-operatively;Change in the main dimension of pain;Change of the recovery time of the gas transit;Change of duration of urinary catheterization;Change in the delay before the first postoperative lift;Change in length of hospitalisation stay and sick leave;Change in neuropathic pain: Neuropathic pain scale (DN4);Change in global health status;Change of the recovery ability;Change in the quality of life