Surgery
Conditions
Keywords
Pain, Polyamine, Cholecystectomy
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPolyamine low-diet
DIETARY_SUPPLEMENTLiberal alimentation
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity for the 7 days | 7 days | Pain intensity is evaluated by the number of tablets of Tramadol taken by the patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores measured on the day of surgery, | 12 hours | Pain score (numerical scale from 0 to 10) measured in mid-afternoon, resting lying down, coughing and mobilization (from lying to sitting position) |
| frequency of impeded hospital discharge the day of surgery | 24 hours | Failure of outpatient care (i.e. the patient cannot leave the hospital the day of surgery) |
| Each day pain | 7 days | 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) . |
| Residual pain | 30 days | Pain score (numerical scale from 0 to 10) |
| Blood levels of polyamine | 2 years | Blood samples are performed the day of surgery and at J7. The dosages will be performed when all patients will be recruited |
| Quality of life | 7 days | QLQC30 Questionnaire (version 3) |
Countries
France
Outcome results
None listed