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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01675-36 | Other Identifier | ANSM |
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End of commercialization of low polyamin diet
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It has been shown that N-methyl-D-aspartate (NMDA) receptor antagonists (such as ketamine) potentiate analgesic drug's efficacy. Polyamines are allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has shown antinociceptive properties. This research aims at evaluating analgesic properties of polyamine-low diet after laparoscopic cholecystectomy performed in an ambulatory setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyamine low-diet | Experimental | Polyamines depleted diet during the week before surgery : 2 cans per day of Polydol (oral alimentation without polyamines), associated to predefined menus low in polyamines |
|
| Liberal alimentation | Active Comparator | No specific alimentary diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyamine low-diet | Dietary Supplement |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity for the 7 days | Pain intensity is evaluated by the number of tablets of Tramadol taken by the patients | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores measured on the day of surgery, | Pain score (numerical scale from 0 to 10) measured in mid-afternoon, resting lying down, coughing and mobilization (from lying to sitting position) | 12 hours |
| frequency of impeded hospital discharge the day of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Fischler, MD | Hopital Foch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Croix Saint-Simon | Paris | Hauts de Seine | 75020 | France |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Liberal alimentation |
| Dietary Supplement |
|
|
Failure of outpatient care (i.e. the patient cannot leave the hospital the day of surgery) |
| 24 hours |
| Each day pain | Pain scores (numerical scale from 0 to 10) assessed daily from J1 ( after surgery) to J7 in mid afternoon , lying at rest position , coughing and mobilization (from lying to sitting position) . | 7 days |
| Quality of life | QLQC30 Questionnaire (version 3) | 7 days |
| Residual pain | Pain score (numerical scale from 0 to 10) | 30 days |
| Blood levels of polyamine | Blood samples are performed the day of surgery and at J7. The dosages will be performed when all patients will be recruited | 2 years |