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

Not Applicable

Completed

• Conditions: Analgesia; Pain Management

• Registration Number: NCT05234216
• Lead Sponsor: Rennes University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-10
• Study Start: 2022-05-09
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 885

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Opiate consumption in the post-operative care service	1 day	Opiate consumption in milligrams in the post-operative care service in morphine equivalent.

Secondary Outcome Measures

Name	Time	Method
Opioid consumption in the post-operative care service according to Ambulatory or conventional management	1 day	Opioid consumption in mg in the post-operative care service in morphine equivalent according to Ambulatory or conventional management
Determine whether the use of a comfort scale reduces postoperative nausea and vomiting;	1 day	Number of postoperative nausea and vomiting episodes in the post-operative care service, the use of anti-emetic treatment will be assessed ;
Opioid consumption in the post-operative care service according to the Type of surgery	1 day	Opioid consumption in mg in the post-operative care service according to the Type of surgery
Determine if the use of a comfort scale in the post-operative care servic is associated with better postoperative analgesia	1 day	Number of postoperative pain episodes (NRS pain \> 3) expressed in the post-operative care servic after extubation, at rest
Determine whether the use of a comfort scale is associated with improved postoperative satisfaction.	1 day	Satisfaction questionnaires
Opioid consumption in the post-operative care service according to the Risk related to surgery (minor / intermediate / major)	1 day	Opioid consumption in mg in the post-operative care service according to the Risk related to surgery (minor / intermediate / major)
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) ;	1 day	Time from extubation to Kremlin Bicetre score = 0, or modified Aldrete score ≥ 9 or Chung score ≥ 9 (for ambulatory) ;

Trial Locations

Locations (29)

Chu Rennes - Pontchaillou; 🇫🇷 Rennes, CHU De Rennes, 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

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