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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05234216
Other study ID # 35RC20_8999_COMFORT
Secondary ID 2021-A02839-32
Status Completed
Phase N/A
First received
Last updated
Start date May 9, 2022
Est. completion date July 1, 2022

Study information

Verified date September 2022
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Informed consent
the investigator will verify the inclusion criteria, the patient's understanding of the protocol and will obtain oral informed consent
Procedure:
Surgery
The patient will undergo surgery in accordance with standard care
Behavioral:
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
Other:
Questionnaires
Evaluation of the Experience of Local/General Anesthesia

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Countries where clinical trial is conducted

France,  Lebanon, 

Outcome

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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