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AnalgesiaEVN/EDAFNCT07310953

Clinical Utility of the Numerical Verbal Scale (NVS) and the Pain and Functional Activity Scale (PFAS) in the Management of Rescue Analgesia in Acute Postoperative Pain. Randomized Study.

A study testing Group A: Rescue analgesia if NVS>4 and Group B: Rescue analgesia if NVSm > 4 + FAS C in people with Analgesia and Post Operative Pain, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

Adequate postoperative pain management, along with mobilization and early oral nutrition, is the foundation for optimal recovery after surgery. Unidimensional pain scales (Numerical Verbal Rating Scale - NRS, Visual Analogue Scale - VAS, Categorical Scale - CRS, Facial Pain Scale - FPS) do not adequately reflect a… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Analgesia, Post Operative Pain, Acute Pain
What is being tested?
Group A: Rescue analgesia if NVS>4 and Group B: Rescue analgesia if NVSm > 4 + FAS C
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteSpain
Study dates
30 Oct 2025to 30 Sep 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Scheduled surgery with VATS admission
  • Age > 18 years
  • Signed informed consent

Who cannot join

  • Cognitive-mental deficit assessed using the Pfeiffer questionnaire. Patients with more than two errors if they have a university degree and more than three errors if they do not have a university degree are excluded from the study.
  • Allergy to any of the analgesic drugs listed on the data collection sheet (Paracetamol / NSAIDs / Metamizole / Dexamethasone / Local anesthetics / Morphine / Fentanyl).
  • Patients who, in the preoperative survey, present any degree of functional limitation according to the FAS scale (Grade B and C).
  • Withdrawal Criteria:
  • If the patient withdraws consent.
  • If the patient experiences delirium, as measured by a positive CAM (Confusion Assessment Method) scale, following surgery.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gustavo Illodo Miramontes, MD contact

986811111 ext. 16246

gustavo.illodo.miramontes@sergas.es

Spain1 site, 1 recruiting
  • Hospital Álvaro Cunqueiro

    Vigo, 36211

    Gustavo Illodo Miramontes

    Recruiting

Other trials in Spain

About this study

Adequate postoperative pain management, along with mobilization and early oral nutrition, is the foundation for optimal recovery after surgery.

Unidimensional pain scales (Numerical Verbal Rating Scale - NRS, Visual Analogue Scale - VAS, Categorical Scale - CRS, Facial Pain Scale - FPS) do not adequately reflect a patient's actual analgesic needs. Basing analgesic treatment on the classic algorithm of administering opioids if pain is greater than 4 on the NRS, without considering functional impairment, has been shown to be a cause of overtreatment in surgical wards.

Read more

The Functional Activity Score (FAS) is the simplest scale, designed for bedside application and geared toward therapeutic decision-making. R: Able to perform any activity; B: Pain prevents some activity; C: Unable to perform any activity.

Given the need to standardize functional limitation when measuring postoperative pain, we propose the Pain and Functional Activity Scale (PFAS), which combines the NVA (Non-Visual Analogue Scale) with the Functional Activity Scale. Specifically, pain on movement would be recorded using the NVA in motion (NVAm), along with functional limitation (A, B, or C). The rescue analgesia treatment algorithm adapted to the PFAS would involve treating patients with pain greater than 4 on the NVA whenever it represents a severe limitation of their functional activity (C).

In this study, we aim to evaluate whether there are significant differences in the proportion of patients who meet the criteria for needing rescue analgesia according to the NVA compared to the proportion of patients who meet the criteria for needing rescue analgesia established by the PFAS, during the 2-day postoperative period.

To this end, an experimental, longitudinal, prospective, randomized, single-blind study for the data analyzer will be carried out, where a group that will receive rescue analgesia if VNS>4 and another if VNSm>4 + FAS C will be compared in the first two days of postoperative surgical patients of the surgeries selected in the EOXI of Vigo.

Being tested
Group A: Rescue analgesia if NVS>4, Group B: Rescue analgesia if NVSm > 4 + FAS C
Keywords
numerical verbal scale, Functional Activity Score
Medical subject headings
Agnosia, Pain, Postoperative, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A: Rescue analgesia if NVS>4Procedure or surgery

    Rescue analgesia will be self-administered by the patient, when post-surgical pain is moderate to severe, using morphine PCA at a dose of 0.075 mg/kg maximum every 15 minutes, up to a maximum of 3 times per hour, provided they meet the criteria described for the group to which they have been assigned.

  • Group B: Rescue analgesia if NVSm > 4 + FAS CProcedure or surgery

    Rescue analgesia will be self-administered by the patient, when post-surgical pain is moderate to severe and this pain interferes with and limits functional activity, using morphine PCA at a dose of 0.075 mg/kg maximum every 15 minutes, up to a maximum of 3 times per hour, provided they meet the criteria described for the group to which they have been assigned.

Study groups in NCT07310953
Study groupRoleWhat they receive
Group AActive comparatorRescue analgesia if EVN>4
Receives: Procedure: Group A: Rescue analgesia if NVS>4
Group BExperimentalRescue analgesia if EVNm >4 + FAS C
Receives: Procedure: Group B: Rescue analgesia if NVSm > 4 + FAS C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NVS

    Resting Numerical Verbal Scale (NVS), indicate one of the following options (0 = no pain 10 = the worst pain imaginable): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10.

    Measured: Day 0 (before the surgical intervention), at 24 and 48 hours and in case rescue analgesia is requested.

  2. mNVS

    Moving Numerical Verbal Scale (mNVS), indicate one of the following options (0 = no pain 10 = the worst pain imaginable): 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10.

    Measured: Day 0 (before the surgical intervention), at 24 and 48 hours and in case rescue analgesia is requested.

  3. FAS

    Functional Activity Score (FAS): After evaluating the following activities: Sitting, Walking, Rehabilitation, Respiratory Physiotherapy; indicate how pain interferes with your functional activity and rank them from best to worst:

    • A: Able to perform any activity (performs all 4 activities without limitation)
    • B: Pain prevents some activity (unable to perform between 1 and 3 of the activities)
    • C: Unable to perform any activity (is unable to perform any of the activities)

    Measured: Day 0 (before the surgical intervention), at 24 and 48 hours and in case rescue analgesia is requested.

Secondary outcomes (16)
  1. Age

    Patient age in years

    Measured: Day 0 (before the surgical intervention)

  2. Gender

    Patient gender (Female, Male)

    Measured: Day 0 (before the surgical intervention)

  3. BMI

    Patient body mass index

    Measured: Day 0 (before the surgical intervention)

  4. Pfeiffer

    Cognitive-mental deficit assessed according to the Pfeiffer questionnaire:

    1. What is today's date (day, month, year)? 2. What day of the week is it today? 3. Where are we now (place or building)? 4. What is your telephone number? (or your address if you don't have a telephone) 5. How old are you? 6. What is your birth year? 7. Who is the current Prime Minister? 8. Who was the previous Prime Minister? 9. What is your mother's second surname? 10. Subtract 3 each time from the number 20.

    Patients with more than 2 errors if they have a university degree and more than 3 errors if they do not have a university degree will be excluded from the study.

    After completing the questionnaire, the variable is recorded as yes/no.

    Measured: Day 0 (before the surgical intervention)

  5. ASA

    Anesthetic risk scale (ASA), indicate one of the following options: 0-No risk, 1-Low risk, 2-Moderate risk, 3-High risk

    Measured: Day 0 (before the surgical intervention)

  6. Risk factors associated with persistent postoperative pain

    Risk factors associated with persistent postoperative pain, indicate the following option(s):

    • Treatment with antidepressants
    • Treatment with anxiolytics/benzodiazepines
    • Catastrophizing (Yes: moderate-to-high risk/ No: low risk) [The Pain Catastrophizing Scale - abbreviated PCS-4 - will be applied). (4-8 low risk; 9-12 moderate risk; 13-16 high risk)
    • Chronic preoperative pain [NV >4 for more than 3 months, in any location]
    • Use of strong opioids and/or tramadol at doses greater than 60 mg/day for more than 3 months
    • History of use of opiates, cannabis, lysergic acid diethylamide (LSD), 3,4-methylenedioxymethamphetamine (MDMA)
    • History of alcohol consumption >40 grams/day in men and >20 grams/day in women

    Measured: Day 0 (before the surgical intervention)

  7. Procedure

    Surgical procedure, indicate one of the following options: Upper lobectomy, Middle lobectomy, Lower lobectomy.

    Measured: Day 1 (after the surgical intervention)

  8. Surgery location

    Surgery location, indicate one of the following options: Right, Left.

    Measured: Day 1 (after the surgical intervention)

  9. Anesthetic technique

    Anesthetic technique, indicate one of the following options: Inhalational general anesthesia, Intravenous general anesthesia

    Measured: Day 1 (after the surgical intervention)

  10. Intraoperative analgesia guidelines

    Intraoperative analgesia guidelines, choose the type of drug: Fentanyl, paracetamol, NSAIDs

    Measured: Day 1 (after the surgical intervention)

  11. Confusión Assessment Method (CAM)

    Postoperative Neurological Status of the Patient by Confusión Assessment Method:

    1. Acute Onset and Fluctuating Course
    2. Inattention
    3. Disorganized Thinking
    4. Altered Level of Consciousness
    5. Alert (normal) 2. Vigilant (hyperalert, very sensitive to environmental stimuli) 3. Lethargic (inhibited, drowsy) 4. Stuporous (difficult to awaken)

    For a diagnosis of delirium, the first two criteria and at least one of the last two are necessary.

    After completing the questionnaire, the variable is recorded as yes/no.

    Measured: at 24 and 48 hours

  12. Analgesia guidelines in the post-surgical intensive care unit

    Analgesia guidelines in the post-surgical intensive care unit, indicate

    • Rescue dose of morphine (PCA)
    • Total dose in mg

    Measured: at 24 and 48 hours

  13. Side effects of analgesia

    Side effects of analgesia, indicate from the following options:

    • Nausea / Vomiting
    • Postoperative ileus [Oral intolerance and/or need for nasogastric tube]
    • Mental confusion / Hallucinations
    • Sedation [Ramsey Scale] see appendix.
    • Pruritus
    • Respiratory depression [Respiratory rate < 12 breaths/min, requiring therapeutic maneuvers]
    • Other (specify)

    Measured: at 24 and 48 hours

  14. Nighttime rest

    Nighttime rest at 24 and 48 hours: Sleep scale. To answer the question "How do I sleep?" the patient responds on a scale from 0 (I don't sleep at all) to 10 (I sleep perfectly).

    Measured: at 24 and 48 hours

  15. Desire for more analgesia

    Desire for more pain relief than received (Yes, No, Don't know)

    Measured: at 48 hours

  16. Satisfaction with pain management therapy

    Satisfaction with pain management therapy using 4 categories:

    • Very dissatisfied
    • Dissatisfied
    • Satisfied
    • Very satisfied

    Measured: at 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2025
  2. Study start30 Oct 2025
  3. Primary completion30 Jul 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07310953
Sponsor's protocol ID
EVN/EDAF
Other IDs
2025/306
Acronym
EVN/EDAF
Status last verified
Feb 2026
First submitted
16 Dec 2025
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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