Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy

Study Overview
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Brief Summary
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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.

Official Title
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Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy

Conditions
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Surgery

Intervention / Treatment
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* Dietary Supplement: Polyamine low-diet
* Dietary Supplement: Liberal alimentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: laparoscopic cholecystectomy ambulatory surgery agreeing to follow a polyamine-low diet with Polydol plus Exclusion Criteria: Pregnancy Contra-indication to a non-steroidal anti-inflammatory, to tramadol Intolerance to cow proteins Diabetic patients Poor understanding of the French language.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyamine low-diet<br>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 | Dietary Supplement: Polyamine low-diet<br> <br> * Other names: Poyldol plus (Nutrialys);|
| Active Comparator: Liberal alimentation<br>No specific alimentary diet | Dietary Supplement: Liberal alimentation<br> <br> * Other names: No specific alimentary recommendation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyamine, Cholecystectomy, Pain