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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02839-32 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comfort Group | Experimental | Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale. |
|
| Pain Group | Other | Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Informed consent | Other | the investigator will verify the inclusion criteria, the patient's understanding of the protocol and will obtain oral informed consent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opiate consumption in the post-operative care service | Opiate consumption in milligrams in the post-operative care service in morphine equivalent. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption in the post-operative care service according to Ambulatory or conventional management | Opioid consumption in mg in the post-operative care service in morphine equivalent according to Ambulatory or conventional management | 1 day |
| Opioid consumption in the post-operative care service according to the Risk related to surgery (minor / intermediate / major) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ludovic MEURET | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Rennes - Pontchaillou | Rennes | CHU de Rennes | 35033 | France | ||
| CHRU Amiens Picardie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39244480 | Derived | 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. |
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Multicenter, prospective, interventional, randomized cluster study.
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| Surgery | Procedure | The patient will undergo surgery in accordance with standard care |
|
| Comfort scale | Behavioral | The patient will be evaluated, in the post-operative care unit, with a comfort scale |
|
| Pain | Behavioral | The patient will be evaluated, in the post-operative care unit, with a pain scale |
|
| Questionnaires | Other | Evaluation of the Experience of Local/General Anesthesia |
|
Opioid consumption in mg in the post-operative care service according to the Risk related to surgery (minor / intermediate / major) |
| 1 day |
| Opioid consumption in the post-operative care service according to the Type of surgery | Opioid consumption in mg in the post-operative care service according to the Type of surgery | 1 day |
| Determine if the use of a comfort scale in the post-operative care servic is associated with better postoperative analgesia | Number of postoperative pain episodes (NRS pain > 3) expressed in the post-operative care servic after extubation, at rest | 1 day |
| 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) ; | Time from extubation to Kremlin Bicetre score = 0, or modified Aldrete score ≥ 9 or Chung score ≥ 9 (for ambulatory) ; | 1 day |
| Determine whether the use of a comfort scale reduces postoperative nausea and vomiting; | Number of postoperative nausea and vomiting episodes in the post-operative care service, the use of anti-emetic treatment will be assessed ; | 1 day |
| Determine whether the use of a comfort scale is associated with improved postoperative satisfaction. | Satisfaction questionnaires | 1 day |
| 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 |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007258 | Informed Consent |
| D013514 | Surgical Procedures, Operative |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D028701 | Patient Rights |
| D006806 | Human Rights |
| D012926 | Social Control, Formal |
| D004472 | Health Care Economics and Organizations |
| D007603 | Jurisprudence |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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