Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy

Hopital Foch

Status and phase: Terminated; Phase 4

Conditions: Surgery

Treatments: Dietary Supplement: Liberal alimentation; Dietary Supplement: Polyamine low-diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02083003

2011-A01675-36 (Other Identifier)

2011/68

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Polyamine low-diet

Experimental group

Description:

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

Treatment:

Dietary Supplement: Polyamine low-diet

Liberal alimentation

Active Comparator group

Description:

No specific alimentary diet

Treatment:

Dietary Supplement: Liberal alimentation