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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07310953
- Acronym / sponsor ID
- EVN/EDAF / EVN/EDAF
- Conditions
- Analgesia, Post Operative Pain, Acute Pain, Functional; Anesthesia
- Keywords
- numerical verbal scale, Functional Activity Score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Fundacin Biomedica Galicia SurUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Group A: Rescue analgesia if NVS>4Rescue analgesia if EVN>4 |
| Group B | Experimental | Procedure: Group B: Rescue analgesia if NVSm > 4 + FAS CRescue analgesia if EVNm >4 + FAS C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled surgery with VATS admission
- Age > 18 years
- Signed informed consent
Key exclusion criteria (6 listed)
- 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).
- If the patient withdraws consent.
- If the patient experiences delirium, as measured by a positive CAM (Confusion Assessment Method) scale, following surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A: Rescue analgesia if NVS>4Rescue 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. | Procedure or surgery | Group A |
| Group B: Rescue analgesia if NVSm > 4 + FAS CRescue 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. | Procedure or surgery | Group B |
Primary outcome
NVS
Time frame: Day 0 (before the surgical intervention), at 24 and 48 hours and in case rescue analgesia is requested.
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.
mNVS
Time frame: Day 0 (before the surgical intervention), at 24 and 48 hours and in case rescue analgesia is requested.
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.
FAS
Time frame: Day 0 (before the surgical intervention), at 24 and 48 hours and in case rescue analgesia is requested.
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)
16 secondary outcomes
Age
Time frame: Day 0 (before the surgical intervention)
Gender
Time frame: Day 0 (before the surgical intervention)
BMI
Time frame: Day 0 (before the surgical intervention)
Pfeiffer
Time frame: Day 0 (before the surgical intervention)
ASA
Time frame: Day 0 (before the surgical intervention)
Risk factors associated with persistent postoperative pain
Time frame: Day 0 (before the surgical intervention)
Procedure
Time frame: Day 1 (after the surgical intervention)
Surgery location
Time frame: Day 1 (after the surgical intervention)
Anesthetic technique
Time frame: Day 1 (after the surgical intervention)
Intraoperative analgesia guidelines
Time frame: Day 1 (after the surgical intervention)
Confusión Assessment Method (CAM)
Time frame: at 24 and 48 hours
Analgesia guidelines in the post-surgical intensive care unit
Time frame: at 24 and 48 hours
Side effects of analgesia
Time frame: at 24 and 48 hours
Nighttime rest
Time frame: at 24 and 48 hours
Desire for more analgesia
Time frame: at 48 hours
Satisfaction with pain management therapy
Time frame: at 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gustavo Illodo Miramontes, MD (986811111 ext. 16246, gustavo.illodo.miramontes@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NVS (time frame: Day 0 (before the surgical intervention), at 24 and 48 hours and in case rescue analgesia is requested.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.