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

NCT05234216 | Completed

• 2 other identifiers: 35RC20_8999_COMFORT2021-A02839-32
• Study Type: interventional
• Target: 885
• Locations: 2 countries
• Sites: 29

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.

Conditions

Pain Management; Analgesia

Keywords

Comfort scale; Pain scale; numerical verbal scale; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Opiate consumption in the post-operative care service

  Opiate consumption in milligrams in the post-operative care service in morphine equivalent.

  1 day

Secondary Outcomes (7)

• Opioid consumption in the post-operative care service 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)

  1 day

• Opioid consumption 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

  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) ;

  1 day

Study Arms (2)

Comfort Group

EXPERIMENTAL

Centers evaluating patients after surgery requiring postoperative opioid treatment with an ICU comfort scale.

Other: Informed consent; Procedure: Surgery; Behavioral: Comfort scale; Other: Questionnaires

Pain Group

OTHER

Centers evaluating patients, after surgery requiring postoperative opioid treatment, with a pain numerical verbal scale in the postoperative care service.

Other: Informed consent; Procedure: Surgery; Behavioral: Pain; Other: Questionnaires

Interventions

Informed consent OTHER

the investigator will verify the inclusion criteria, the patient's understanding of the protocol and will obtain oral informed consent

Comfort Group; Pain Group

Surgery PROCEDURE

The patient will undergo surgery in accordance with standard care

Comfort Group; Pain Group

Comfort scale BEHAVIORAL

The patient will be evaluated, in the post-operative care unit, with a comfort scale

Comfort Group

Pain BEHAVIORAL

The patient will be evaluated, in the post-operative care unit, with a pain scale

Pain Group

Questionnaires OTHER

Evaluation of the Experience of Local/General Anesthesia

Comfort Group; Pain Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (29)

Chu Rennes - Pontchaillou

Rennes, CHU de Rennes, 35033, France

Location

CHRU Amiens Picardie

Amiens, France

Location

CHU Angers

Angers, France

Location

CH Bourg en Bresse

Bourg-en-Bresse, France

Location

CH Pierre Oudot

Bourgoin, France

Location

HIA Clermont Tonnerre

Brest, France

Location

Hôpital Privé Sévigné

Cesson-Sévigné, France

Location

CH Sud Francilien

Corbeil-Essonnes, France

Location

CH Dax

Dax, France

Location

GHM de Grenoble

Grenoble, France

Location

CH La Rochelle

La Rochelle, France

Location

CHRU Lille - Hôpital Huriez

Lille, France

Location

CH Saint Joseph Saint Luc

Lyon, France

Location

Clinique du Parc

Lyon, France

Location

Clinique Juge

Marseille, France

Location

Clinique Jules Verne

Nantes, France

Location

APHP - Hôpital Bichat

Paris, France

Location

APHP - Hôpital Cochin

Paris, France

Location

Polyclinique Saint Laurent de Rennes

Rennes, France

Location

CH Saint-Brieuc

Saint-Brieuc, France

Location

Centre Hospitalier Privé St Grégoire

Saint-Grégoire, France

Location

Clinique Saint-Jean Cap Santé

Saint-Jean-de-Védas, France

Location

CHRU Strasbourg - Hôpital Hautepierre

Strasbourg, France

Location

Hôpital Foch

Suresnes, France

Location

CHU Toulouse - Hôpital Rangueil

Toulouse, France

Location

CHU Toulouse - Hôpital Riquet

Toulouse, France

Location

CHRU Tours - Hôpital Bretonneau

Tours, France

Location

CH Bretagne Atlantique

Vannes, France

Location

Hôpital Hôtel Dieu de France

Beirut, Lebanon

Location

Related Publications (1)

• Fusco N, Meuret L, Bernard F, Musellec H, Martin L, Leonard M, Lasocki S, Gazeau T, Aubertin R, Blayac D, Leviel F, Danguy des Deserts M, Madi-Jebara S, Fessler J, Lecoeur S, Cirenei C, Menut R, Lebreton C, Bouvier S, Bonnet C, Maurice-Szamburski A, Cattenoz M, El Alami M, Brocas E, Aveline C, Gueguen L, Noll E, Gouel-Cheron A, Evrard O, Fontaine M, Nguyen YL, Ravry C, Boselli E, Laviolle B, Beloeil H; COMFORT Study Group and the French Society of Anesthesiologists (SFAR) Research Network. Effect of a comfort scale compared with a pain numerical rate scale on opioids consumption in postanaesthesia care unit: the COMFORT study. Br J Anaesth. 2024 Oct;133(4):839-845. doi: 10.1016/j.bja.2024.06.029. Epub 2024 Sep 7.

  PMID: 39244480 DERIVED

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Informed Consent; Surgical Procedures, Operative; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Patient Rights; Human Rights; Social Control, Formal; Health Care Economics and Organizations; Jurisprudence; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ludovic MEURET

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, prospective, interventional, randomized cluster study.

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 10, 2022
• Study Start: May 9, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 23, 2022

Record last verified: 2022-09

Locations

FR (28); LE (1)