Postoperative Pain
Conditions
Brief summary
Animal studies have shown that the level of pain sensitivity is highly dependent on the amount of polyamines in food. This fundamental observation of a nutritional approach to pain led the authors to develop diets completely depleted in polyamines whose anti-nociceptive properties have been confirmed in animals. Postoperative pain after foot surgery are currently fairly well controlled but at the cost of a high consumption of grade II analgesics which is associated with a high rate of side effects (nausea, vomiting ...). The investigators' hypothesis is that a diet low in polyamines may have an additive effect on pain control and reduce the consumption of level 2 analgesics. The objective of this study is to show the efficacy of a polyamines-poor diet on postoperative pain in ambulatory surgery of the foot.
Interventions
OTHERpoor-polyamines diet
Patients in this will receive a poor-polyamines diet during a week before and a week after foot surgery
OTHERhigh polyamines diet
Patients in this will receive a high-polyamines diet during a week before and a week after foot surgery
Sponsors
Groupe Hospitalier Diaconesses Croix Saint-Simon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* foot ambulatory orthopedic surgery * surgery scheduled at least 10 days after the inclusion consultation
Exclusion criteria
* other diet susceptible to interfere with the poor or high-polyamines diets (e.g. diabetic patients) * contraindication to tramadol or to NSAIDs * pregnant or breastfeeding woman * patient under legal protection * patient's opposition to participate in the study * poor understanding of French * absence of affiliation to social security * participation to another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients whose worst pain, as measured on an visual analogic scale ranging from 0 mm to 100 mm, was at least once rated as 30 mm or more. | Eight days after surgery | The worst pain will be assessed retrospectively the eighth day after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with a need for grade II analgesics | Eighth day after surgery | — |
| Overall tramadol consumption , expressed in mg. | Eight days after surgery | — |
| Worst pain, expressed in mm, measured on an visual analogic scale ranging from 0 mm to 100 mm | Eight days after surgery | The worst pain will be assessed retrospectively the eighth day after surgery |
Countries
France
Outcome results
None listed