Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery
- Conditions
- Digestive System Surgical Procedures
- Interventions
- Other: Polyamine Deficient Diet
- Registration Number
- NCT04219956
- Lead Sponsor
- Nantes University Hospital
- Brief 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.
- Detailed Description
Morphine derivatives are known to be a major cause of postoperative ileus and also operative hyperalgesia. Operative hyperalgesia corresponds to an increase in morphine needs postoperatively which is proportional to the morphine dose necessary during the surgery. This effect is due to two mechanisms: opioids tolerance and induced hypersensitivity.
N-methyl-D-aspartate receptors (R-NMDA) play a key role in this induced hypersensitivity. Polyamines, organic compounds with several amines functions, are known R-NMDA agonists. They increase the phosphorylation of the tyrosine group within the NR2B subunit responsible for the inflammatory hyperalgesia.
Limiting the binding of polyamines to the R-NMDA seems an easy, safe and efficient way to limit the hypersensitivity induced post-operatively.
Most of the polyamines in the human body come from food. One study listed food regarding their polyamines content and allowed to check the safety of a polyamine deficient diet. Such a well-followed diet would allow to reduce by 20 the polyamines quantity present in the body.
The aim of this study is to evaluate whether a deficient polyamine diet introduced 7 days before and continued up to 7 days after an abdominal surgery requiring the use of morphine post-operatively reduces the post-operative pain, the consumption of analgesics (morphine) post-operatively and improve the recovery ability. Abdominals surgeries concerned will be the eventration cure and digestive continuity.
The medico-economic impact will be observed during this study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 278
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Polyamine deficient diet Polyamine Deficient Diet Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet
- 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 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
- Secondary Outcome Measures
Name Time Method Change in the main dimension of pain 6 months post-surgery Evaluation of the main dimension of pain using the Brief Pain Inventory (BPI)
Change in the analgesics consumption post-operatively 15 days post-surgery Measure of the analgesics consumption by the nurse during hospitalisation and by the patient with the patient book up to 15 days postsurgery
Change of the recovery time of the gas transit 6 months post-surgery Evaluation of the time to recover the gas transit post-surgery (in days)
Change in neuropathic pain: Neuropathic pain scale (DN4) 6 months post-surgery Use of the Neuropathic pain scale for patients seen for their postsurgery pain or complications. The scale contains 10 questions, the range is between 0-10, 10 being the worst score.
Change of duration of urinary catheterization 6 months post-surgery Recovery of spontaneous urination post-surgery (in days)
Change in the delay before the first postoperative lift 6 months post-surgery Time before walking post-surgery (in days)
Change in length of hospitalisation stay and sick leave 6 months post-surgery Hospitalisation time and sick leave (in days)
Change in global health status 1 month before surgery, 1 month and 6 months post-surgery Use of autoquestionnaire EuroQol-5 Dimension (EQ-5D) to evaluate the global health status of the patients. The scale contains two parts, the first one contains 5 items to be completed by the patients with 5 levels for each item, the worst score being 55555. The second part is an analog visual scale with a range between 0-100, 0 being the worst score.
Change of the recovery ability 1 month before surgery, 1 month and 6 months post-surgery Evaluation of the recovery ability using the Quality of Recovery-15 Questionnaire (QoR-15)
Change in the quality of life 1 month before surgery, 1 month and 6 months post-surgery Assessment of the patient's quality of life by using the Short-Form Health Survey 36 questionnaire (SF-36)
Trial Locations
- Locations (4)
CHD Vendée
🇫🇷La Roche-sur-Yon, France
Hôpital Louis Mourier from Ap-HP
🇫🇷Colombes, France
CHRU Brest La Cavale Blanche
🇫🇷Brest, France
CHU Nantes Hôtel Dieu
🇫🇷Nantes, France