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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Pain Management
• Intervention / Treatment: Other: Informed consent; Procedure: Surgery; Behavioral: Comfort scale; Other: Questionnaires; Behavioral: Pain

• Study Type: Interventional
• Enrollment (Actual): 885
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHRU Amiens Picardie
  • Angers, France
    • CHU Angers
  • Bourg-en-Bresse, France
    • Ch Bourg En Bresse
  • Bourgoin-Jallieu, France
    • CH Pierre Oudot
  • Brest, France
    • HIA Clermont Tonnerre
  • Cesson-Sévigné, France
    • Hôpital Privé Sévigné
  • Corbeil-Essonnes, France
    • CH Sud Francilien
  • Dax, France
    • CH Dax
  • Grenoble, France
    • GHM de Grenoble
  • La Rochelle, France
    • CH La Rochelle
  • Lille, France
    • CHRU Lille - Hôpital Huriez
  • Lyon, France
    • CH Saint Joseph Saint Luc
  • Lyon, France
    • Clinique du Parc
  • Marseille, France
    • Clinique Juge
  • Nantes, France
    • Clinique Jules Verne
  • Paris, France
    • APHP - Hôpital Cochin
  • Paris, France
    • APHP - Hôpital BICHAT
  • Rennes, France
    • Polyclinique Saint Laurent de Rennes
  • Saint-Brieuc, France
    • CH Saint-Brieuc
  • Saint-Grégoire, France
    • Centre Hospitalier Privé St Grégoire
  • Saint-Jean-de-Védas, France
    • Clinique Saint-Jean Cap Santé
  • Strasbourg, France
    • CHRU Strasbourg - Hôpital Hautepierre
  • Suresnes, France
    • Hôpital Foch
  • Toulouse, France
    • CHU Toulouse - Hôpital Rangueil
  • Toulouse, France
    • CHU Toulouse - Hôpital Riquet
  • Tours, France
    • CHRU Tours - Hôpital Bretonneau
  • Vannes, France
    • CH Bretagne Atlantique
  • CHU De Rennes
    • Rennes, CHU De Rennes, France, 35033
      • CHU Rennes - Pontchaillou
• Lebanon
  • Beyrouth, Lebanon
    • Hôpital Hôtel Dieu de France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comfort Group; Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale.	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; Other: Questionnaires; Evaluation of the Experience of Local/General Anesthesia
Other: Pain Group; Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service.	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; Other: Questionnaires; Evaluation of the Experience of Local/General Anesthesia; Behavioral: Pain; The patient will be evaluated, in the post-operative care unit, with a pain scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Ludovic MEURET, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: postoperative pain; Pain scale; Comfort scale; numerical verbal scale
• Other Study ID Numbers: 35RC20_8999_COMFORT; 2021-A02839-32 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No