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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain Management, Analgesia

Intervention / Treatment
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* Other: Informed consent
* Procedure: Surgery
* Behavioral: Comfort scale
* Behavioral: Pain
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, prospective, interventional, randomized cluster study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comfort Group<br>Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale. | Other: Informed consent<br>* the investigator will verify the inclusion criteria, the patient's understanding of the protocol and will obtain oral informed consent<br>Procedure: Surgery<br>* The patient will undergo surgery in accordance with standard care<br>Behavioral: Comfort scale<br>* The patient will be evaluated, in the post-operative care unit, with a comfort scale<br>Other: Questionnaires<br>* Evaluation of the Experience of Local/General Anesthesia<br>|
| Other: Pain Group<br>Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service. | Other: Informed consent<br>* the investigator will verify the inclusion criteria, the patient's understanding of the protocol and will obtain oral informed consent<br>Procedure: Surgery<br>* The patient will undergo surgery in accordance with standard care<br>Behavioral: Pain<br>* The patient will be evaluated, in the post-operative care unit, with a pain scale<br>Other: Questionnaires<br>* Evaluation of the Experience of Local/General Anesthesia<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comfort scale, Pain scale, numerical verbal scale, postoperative pain