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Completed

NCT Number: NCT05234216

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Rennes - Pontchaillou, Rennes, CHU de Rennes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Informed consent

Other

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

Surgery

Procedure

The patient will undergo surgery in accordance with standard care

Comfort scale

Behavioral

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

Pain

Behavioral

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

questionnaires

Other

Evaluation of the Experience of Local/General Anesthesia

Primary outcomes

  1. Opiate consumption in the post-operative care service

    Time frame: 1 day

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

Secondary outcomes

  1. Opioid consumption in the post-operative care service according to Ambulatory or conventional management

    Time frame: 1 day

    Opioid consumption in mg in the post-operative care service in morphine equivalent according to Ambulatory or conventional management

  2. Opioid consumption in the post-operative care service according to the Risk related to surgery (minor / intermediate / major)

    Time frame: 1 day

    Opioid consumption in mg in the post-operative care service according to the Risk related to surgery (minor / intermediate / major)

  3. Opioid consumption in the post-operative care service according to the Type of surgery

    Time frame: 1 day

    Opioid consumption in mg in the post-operative care service according to the Type of surgery

  4. Determine if the use of a comfort scale in the post-operative care servic is associated with better postoperative analgesia

    Time frame: 1 day

    Number of postoperative pain episodes (NRS pain > 3) expressed in the post-operative care servic after extubation, at rest

  5. 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 frame: 1 day

    Time from extubation to Kremlin Bicetre score = 0, or modified Aldrete score ≥ 9 or Chung score ≥ 9 (for ambulatory) ;

  6. Determine whether the use of a comfort scale reduces postoperative nausea and vomiting;

    Time frame: 1 day

    Number of postoperative nausea and vomiting episodes in the post-operative care service, the use of anti-emetic treatment will be assessed ;

  7. Determine whether the use of a comfort scale is associated with improved postoperative satisfaction.

    Time frame: 1 day

    Satisfaction questionnaires

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: COMFORT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2022
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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