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

Analgesia Clinical Trial

— COMFORT  

Official title:

Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery: The COMFORT Randomized Trial

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
• 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
• 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.

Related Conditions & MeSH terms

• Analgesia
• Pain Management

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