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.
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.
Spain1 site, 1 recruiting
- Recruiting
Hospital Álvaro Cunqueiro
Vigo, 36211
Gustavo Illodo Miramontes
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.
- Conditions
- Analgesia, Post Operative Pain, Acute Pain, Functional; Anesthesia
- 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 group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Rescue analgesia if EVN>4 Receives: Procedure: Group A: Rescue analgesia if NVS>4 |
| Group B | Experimental | Rescue 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.
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.
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.
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)
Age
Patient age in years
Measured: Day 0 (before the surgical intervention)
Gender
Patient gender (Female, Male)
Measured: Day 0 (before the surgical intervention)
BMI
Patient body mass index
Measured: Day 0 (before the surgical intervention)
Pfeiffer
Cognitive-mental deficit assessed according to the Pfeiffer questionnaire:
- 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)
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)
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)
Procedure
Surgical procedure, indicate one of the following options: Upper lobectomy, Middle lobectomy, Lower lobectomy.
Measured: Day 1 (after the surgical intervention)
Surgery location
Surgery location, indicate one of the following options: Right, Left.
Measured: Day 1 (after the surgical intervention)
Anesthetic technique
Anesthetic technique, indicate one of the following options: Inhalational general anesthesia, Intravenous general anesthesia
Measured: Day 1 (after the surgical intervention)
Intraoperative analgesia guidelines
Intraoperative analgesia guidelines, choose the type of drug: Fentanyl, paracetamol, NSAIDs
Measured: Day 1 (after the surgical intervention)
Confusión Assessment Method (CAM)
Postoperative Neurological Status of the Patient by Confusión Assessment Method:
- Acute Onset and Fluctuating Course
- Inattention
- Disorganized Thinking
- Altered Level of Consciousness
- 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
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
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
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
Desire for more analgesia
Desire for more pain relief than received (Yes, No, Don't know)
Measured: at 48 hours
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.
- First posted30 Dec 2025
- Study start30 Oct 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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