Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery

NCT ID: NCT05234216

Last Updated: 2022-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

885 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-09

Study Completion Date

2022-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Management Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter, prospective, interventional, randomized cluster study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Comfort Group

Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale.

Group Type EXPERIMENTAL

Informed consent

Intervention Type OTHER

the investigator will verify the inclusion criteria, the patient's understanding of the protocol and will obtain oral informed consent

Surgery

Intervention Type PROCEDURE

The patient will undergo surgery in accordance with standard care

Comfort scale

Intervention Type BEHAVIORAL

The patient will be evaluated, in the post-operative care unit, with a comfort scale

Questionnaires

Intervention Type OTHER

Evaluation of the Experience of Local/General Anesthesia

Pain Group

Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service.

Group Type OTHER

Informed consent

Intervention Type OTHER

the investigator will verify the inclusion criteria, the patient's understanding of the protocol and will obtain oral informed consent

Surgery

Intervention Type PROCEDURE

The patient will undergo surgery in accordance with standard care

Pain

Intervention Type BEHAVIORAL

The patient will be evaluated, in the post-operative care unit, with a pain scale

Questionnaires

Intervention Type OTHER

Evaluation of the Experience of Local/General Anesthesia

Interventions

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Informed consent

the investigator will verify the inclusion criteria, the patient's understanding of the protocol and will obtain oral informed consent

Intervention Type OTHER

Surgery

The patient will undergo surgery in accordance with standard care

Intervention Type PROCEDURE

Comfort scale

The patient will be evaluated, in the post-operative care unit, with a comfort scale

Intervention Type BEHAVIORAL

Pain

The patient will be evaluated, in the post-operative care unit, with a pain scale

Intervention Type BEHAVIORAL

Questionnaires

Evaluation of the Experience of Local/General Anesthesia

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ludovic MEURET

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

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Chu Rennes - Pontchaillou

Rennes, CHU de Rennes, France

Site Status

CHRU Amiens Picardie

Amiens, , France

Site Status

CHU Angers

Angers, , France

Site Status

CH Bourg en Bresse

Bourg-en-Bresse, , France

Site Status

CH Pierre Oudot

Bourgoin, , France

Site Status

HIA Clermont Tonnerre

Brest, , France

Site Status

Hôpital Privé Sévigné

Cesson-Sévigné, , France

Site Status

CH Sud Francilien

Corbeil-Essonnes, , France

Site Status

CH Dax

Dax, , France

Site Status

GHM de Grenoble

Grenoble, , France

Site Status

CH La Rochelle

La Rochelle, , France

Site Status

CHRU Lille - Hôpital Huriez

Lille, , France

Site Status

CH Saint Joseph Saint Luc

Lyon, , France

Site Status

Clinique du Parc

Lyon, , France

Site Status

Clinique Juge

Marseille, , France

Site Status

Clinique Jules Verne

Nantes, , France

Site Status

APHP - Hôpital Bichat

Paris, , France

Site Status

APHP - Hôpital Cochin

Paris, , France

Site Status

Polyclinique Saint Laurent de Rennes

Rennes, , France

Site Status

CH Saint-Brieuc

Saint-Brieuc, , France

Site Status

Centre Hospitalier Privé St Grégoire

Saint-Grégoire, , France

Site Status

Clinique Saint-Jean Cap Santé

Saint-Jean-de-Védas, , France

Site Status

CHRU Strasbourg - Hôpital Hautepierre

Strasbourg, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

CHU Toulouse - Hôpital Rangueil

Toulouse, , France

Site Status

CHU Toulouse - Hôpital Riquet

Toulouse, , France

Site Status

CHRU Tours - Hôpital Bretonneau

Tours, , France

Site Status

CH Bretagne Atlantique

Vannes, , France

Site Status

Hôpital Hôtel Dieu de France

Beirut, , Lebanon

Site Status

Countries

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France Lebanon

References

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Fusco N, Meuret L, Bernard F, Musellec H, Martin L, Leonard M, Lasocki S, Gazeau T, Aubertin R, Blayac D, Leviel F, Danguy des Deserts M, Madi-Jebara S, Fessler J, Lecoeur S, Cirenei C, Menut R, Lebreton C, Bouvier S, Bonnet C, Maurice-Szamburski A, Cattenoz M, El Alami M, Brocas E, Aveline C, Gueguen L, Noll E, Gouel-Cheron A, Evrard O, Fontaine M, Nguyen YL, Ravry C, Boselli E, Laviolle B, Beloeil H; COMFORT Study Group and the French Society of Anesthesiologists (SFAR) Research Network. Effect of a comfort scale compared with a pain numerical rate scale on opioids consumption in postanaesthesia care unit: the COMFORT study. Br J Anaesth. 2024 Oct;133(4):839-845. doi: 10.1016/j.bja.2024.06.029. Epub 2024 Sep 7.

Reference Type DERIVED
PMID: 39244480 (View on PubMed)

Other Identifiers

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2021-A02839-32

Identifier Type: OTHER

Identifier Source: secondary_id

35RC20_8999_COMFORT

Identifier Type: -

Identifier Source: org_study_id

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