Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy

Phase 4

Terminated

• Conditions: Surgery
• Interventions: Dietary Supplement: Polyamine low-diet; Dietary Supplement: Liberal alimentation

• Registration Number: NCT02083003
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-07
• Study First Posted: 2014-03-11
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• laparoscopic cholecystectomy
• ambulatory surgery
• agreeing to follow a polyamine-low diet with Polydol plus

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polyamine low-diet	Polyamine low-diet	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	Liberal alimentation	No specific alimentary diet

Primary Outcome Measures

Name	Time	Method
Pain intensity for the 7 days	7 days	Pain intensity is evaluated by the number of tablets of Tramadol taken by the patients

Secondary Outcome Measures

Name	Time	Method
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)
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) .
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
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)
Quality of life	7 days	QLQC30 Questionnaire (version 3)
Residual pain	30 days	Pain score (numerical scale from 0 to 10)

Trial Locations

Locations (1)

Hôpital de la Croix Saint-Simon; 🇫🇷 Paris, Hauts de Seine, France