Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy

Surgery Clinical Trial

Official title:

Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02083003
• Other study ID #: 2011/68
• Secondary ID: 2011-A01675-36
• Status: Terminated
• Phase: Phase 4
• First received: March 7, 2014
• Last updated: November 2, 2016
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: November 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 76 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Surgery

Intervention

Dietary Supplement:
• Polyamine low-diet

• Liberal alimentation

Locations

Country	Name	City	State
France	Hôpital de la Croix Saint-Simon	Paris	Hauts de Seine

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity for the 7 days	Pain intensity is evaluated by the number of tablets of Tramadol taken by the patients	7 days	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Quality of life	QLQC30 Questionnaire (version 3)	7 days	No
Secondary	Residual pain	Pain score (numerical scale from 0 to 10)	30 days	No
Secondary	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	No