Clinical trial NCT05234216: Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery
Official title: Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery: The COMFORT Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Analgesia
Keywords: Comfort scale
Pain scale
numerical verbal scale
postoperative pain
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 885
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, prospective, interventional, randomized cluster study.
Primary purpose: TREATMENT

Brief summary: The objective is to show that the use of therapeutic communication tools, in this case a comfort scale, a low cost and simple to implement method, can reduce pain and therefore the consumption of opioids in the postoperative care unit.

Our hypothesis is that the use of a comfort scale will lead to significant postoperative opioid sparing, and consequently to a decrease in the opioid-related side effects The aim of this study is to compare postoperative opioid consumption between patients whose pain is assessed by a numerical verbal scale and those assessed with a comfort scale.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Patient eligible for any surgery requiring postoperative opioid administration;
* Patient with a social security plan;
* French-speaking patient
* Free, informed and oral consent by the patient.

Exclusion Criteria:

* Woman claiming to be pregnant or breast feeding;
* Emergency surgery;
* Patients using preoperative opioids ;
* Opioid addiction;
* Patients unable to understand the assessment scales;
* Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.

Primary outcomes:
measure: Opiate consumption in the post-operative care service
timeFrame: 1 day
Secondary outcomes:
measure: Opioid consumption in the post-operative care service according to Ambulatory or conventional management
timeFrame: 1 day
measure: Opioid consumption in the post-operative care service according to the Risk related to surgery (minor / intermediate / major)
timeFrame: 1 day
measure: Opioid consumption in the post-operative care service according to the Type of surgery
timeFrame: 1 day
measure: Determine if the use of a comfort scale in the post-operative care servic is associated with better postoperative analgesia
timeFrame: 1 day
measure: Determine if the use of a comfort scale can reduce the time to achieve a Kremlin Bicetre score = 0, or a modified Aldrete score ≥ 9 or a Chung score ≥ 9 (for ambulatory) ;
timeFrame: 1 day
measure: Determine whether the use of a comfort scale reduces postoperative nausea and vomiting;
timeFrame: 1 day
measure: Determine whether the use of a comfort scale is associated with improved postoperative satisfaction.
timeFrame: 1 day
Other outcomes:
Locations:
city: Rennes
country: France
facility: Chu Rennes - Pontchaillou
state: CHU De Rennes
city: Amiens
country: France
facility: CHRU Amiens Picardie
city: Angers
country: France
facility: CHU Angers
city: Bourg-en-Bresse
country: France
facility: CH Bourg en Bresse
city: Bourgoin-Jallieu
country: France
facility: CH Pierre Oudot
city: Brest
country: France
facility: HIA Clermont Tonnerre
city: Cesson-Sévigné
country: France
facility: Hôpital Privé Sévigné
city: Corbeil-Essonnes
country: France
facility: CH Sud Francilien
city: Dax
country: France
facility: CH Dax
city: Grenoble
country: France
facility: GHM de Grenoble
city: La Rochelle
country: France
facility: CH La Rochelle
city: Lille
country: France
facility: CHRU Lille - Hôpital Huriez
city: Lyon
country: France
facility: CH Saint Joseph Saint Luc
city: Lyon
country: France
facility: Clinique du Parc
city: Marseille
country: France
facility: Clinique Juge
city: Nantes
country: France
facility: Clinique Jules Verne
city: Paris
country: France
facility: APHP - Hôpital Bichat
city: Paris
country: France
facility: APHP - Hôpital Cochin
city: Rennes
country: France
facility: Polyclinique Saint Laurent de Rennes
city: Saint-Brieuc
country: France
facility: CH Saint-Brieuc
city: Saint-Grégoire
country: France
facility: Centre Hospitalier Privé St Grégoire
city: Saint-Jean-de-Védas
country: France
facility: Clinique Saint-Jean Cap Santé
city: Strasbourg
country: France
facility: CHRU Strasbourg - Hôpital Hautepierre
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Rangueil
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Riquet
city: Tours
country: France
facility: CHRU Tours - Hôpital Bretonneau
city: Vannes
country: France
facility: CH Bretagne Atlantique
city: Beyrouth
country: Lebanon
facility: Hôpital Hôtel Dieu de France
Study officials:
affiliation: Rennes University Hospital
name: Ludovic MEURET
role: PRINCIPAL_INVESTIGATOR
References: