Analgesia Clinical Trial
— COMFORTOfficial title:
Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery: The COMFORT Randomized Trial
Verified date | September 2022 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 885 |
Est. completion date | July 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | CHRU Amiens Picardie | Amiens | |
France | CHU Angers | Angers | |
France | CH Bourg en Bresse | Bourg-en-Bresse | |
France | CH Pierre Oudot | Bourgoin-Jallieu | |
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 | Chu Rennes - Pontchaillou | Rennes | CHU De Rennes |
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 | |
Lebanon | Hôpital Hôtel Dieu de France | Beyrouth |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France, Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opiate consumption in the post-operative care service | Opiate consumption in milligrams in the post-operative care service in morphine equivalent. | 1 day | |
Secondary | 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 | |
Secondary | Opioid consumption in the post-operative care service according to the Risk related to surgery (minor / intermediate / major) | Opioid consumption in mg in the post-operative care service according to the Risk related to surgery (minor / intermediate / major) | 1 day | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Determine whether the use of a comfort scale is associated with improved postoperative satisfaction. | Satisfaction questionnaires | 1 day |
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