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

Not Applicable

Completed

• Conditions: Analgesia; Pain Management
• Interventions: Other: Informed consent; Procedure: Surgery; Behavioral: Comfort scale; Behavioral: Pain; Other: Questionnaires

• 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

Arm && Interventions

Group	Intervention	Description
Comfort Group	Comfort scale	Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale.
Comfort Group	Surgery	Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale.
Pain Group	Informed consent	Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service.
Comfort Group	Questionnaires	Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale.
Comfort Group	Informed consent	Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale.
Pain Group	Surgery	Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service.
Pain Group	Pain	Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service.
Pain Group	Questionnaires	Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service.

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

CH Pierre Oudot; 🇫🇷 Bourgoin-Jallieu, France

GHM de Grenoble; 🇫🇷 Grenoble, France

CHRU Lille - Hôpital Huriez; 🇫🇷 Lille, France

Clinique du Parc; 🇫🇷 Lyon, France

Polyclinique Saint Laurent de Rennes; 🇫🇷 Rennes, France

APHP - Hôpital Cochin; 🇫🇷 Paris, France

APHP - Hôpital Bichat; 🇫🇷 Paris, France

CH Saint-Brieuc; 🇫🇷 Saint-Brieuc, France

Clinique Saint-Jean Cap Santé; 🇫🇷 Saint-Jean-de-Védas, France

CHRU Strasbourg - Hôpital Hautepierre; 🇫🇷 Strasbourg, France

Clinique Juge; 🇫🇷 Marseille, France

CHRU Amiens Picardie; 🇫🇷 Amiens, France

CH Bourg en Bresse; 🇫🇷 Bourg-en-Bresse, France

CH Saint Joseph Saint Luc; 🇫🇷 Lyon, France

HIA Clermont Tonnerre; 🇫🇷 Brest, France

Hôpital Privé Sévigné; 🇫🇷 Cesson-Sévigné, France

Clinique Jules Verne; 🇫🇷 Nantes, France

Hôpital Foch; 🇫🇷 Suresnes, France

CH Bretagne Atlantique; 🇫🇷 Vannes, France

Hôpital Hôtel Dieu de France; 🇱🇧 Beyrouth, Lebanon

CHU Angers; 🇫🇷 Angers, France

CH Dax; 🇫🇷 Dax, France

CHU Toulouse - Hôpital Riquet; 🇫🇷 Toulouse, France

Centre Hospitalier Privé St Grégoire; 🇫🇷 Saint-Grégoire, France

CH La Rochelle; 🇫🇷 La Rochelle, France

CH Sud Francilien; 🇫🇷 Corbeil-Essonnes, France

CHU Toulouse - Hôpital Rangueil; 🇫🇷 Toulouse, France

CHRU Tours - Hôpital Bretonneau; 🇫🇷 Tours, France