Trials / Completed
CompletedNCT02592460
Postoperative Pain and Polyamines-poor Diet (DOLAMINE)
Impact on Pain of a Preoperative Polyamines-poor Diet After Orthopedic Surgery of the Foot
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 542 (actual)
- Sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | poor-polyamines diet | Patients in this will receive a poor-polyamines diet during a week before and a week after foot surgery |
| OTHER | high polyamines diet | Patients in this will receive a high-polyamines diet during a week before and a week after foot surgery |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2017-07-01
- Completion
- 2017-07-01
- First posted
- 2015-10-30
- Last updated
- 2019-02-15
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02592460. Inclusion in this directory is not an endorsement.