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
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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COMPLETED
NA
885 participants
INTERVENTIONAL
2022-05-09
2022-07-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Comfort Group
Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale.
Informed consent
the investigator will verify the inclusion criteria, the patient's understanding of the protocol and will obtain oral informed consent
Surgery
The patient will undergo surgery in accordance with standard care
Comfort scale
The patient will be evaluated, in the post-operative care unit, with a comfort scale
Questionnaires
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.
Informed consent
the investigator will verify the inclusion criteria, the patient's understanding of the protocol and will obtain oral informed consent
Surgery
The patient will undergo surgery in accordance with standard care
Pain
The patient will be evaluated, in the post-operative care unit, with a pain scale
Questionnaires
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
Surgery
The patient will undergo surgery in accordance with standard care
Comfort scale
The patient will be evaluated, in the post-operative care unit, with a comfort scale
Pain
The patient will be evaluated, in the post-operative care unit, with a pain scale
Questionnaires
Evaluation of the Experience of Local/General Anesthesia
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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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
CHRU Amiens Picardie
Amiens, , France
CHU Angers
Angers, , France
CH Bourg en Bresse
Bourg-en-Bresse, , France
CH Pierre Oudot
Bourgoin, , France
HIA Clermont Tonnerre
Brest, , France
Hôpital Privé Sévigné
Cesson-Sévigné, , France
CH Sud Francilien
Corbeil-Essonnes, , France
CH Dax
Dax, , France
GHM de Grenoble
Grenoble, , France
CH La Rochelle
La Rochelle, , France
CHRU Lille - Hôpital Huriez
Lille, , France
CH Saint Joseph Saint Luc
Lyon, , France
Clinique du Parc
Lyon, , France
Clinique Juge
Marseille, , France
Clinique Jules Verne
Nantes, , France
APHP - Hôpital Bichat
Paris, , France
APHP - Hôpital Cochin
Paris, , France
Polyclinique Saint Laurent de Rennes
Rennes, , France
CH Saint-Brieuc
Saint-Brieuc, , France
Centre Hospitalier Privé St Grégoire
Saint-Grégoire, , France
Clinique Saint-Jean Cap Santé
Saint-Jean-de-Védas, , France
CHRU Strasbourg - Hôpital Hautepierre
Strasbourg, , France
Hôpital Foch
Suresnes, , France
CHU Toulouse - Hôpital Rangueil
Toulouse, , France
CHU Toulouse - Hôpital Riquet
Toulouse, , France
CHRU Tours - Hôpital Bretonneau
Tours, , France
CH Bretagne Atlantique
Vannes, , France
Hôpital Hôtel Dieu de France
Beirut, , Lebanon
Countries
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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.
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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