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.

NCT07310953 | Recruiting DMC

• 2 other identifiers: EVN/EDAF2025/306
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Analgesia; Post Operative Pain; Acute Pain; Functional; Anesthesia

Keywords

numerical verbal scale; Functional Activity Score

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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)

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

Secondary Outcomes (16)

• Age

  Day 0 (before the surgical intervention)

• Gender

  Day 0 (before the surgical intervention)

• BMI

  Day 0 (before the surgical intervention)

• Pfeiffer

  Day 0 (before the surgical intervention)

• ASA

  Day 0 (before the surgical intervention)

Study Arms (2)

Group A

ACTIVE COMPARATOR

Rescue analgesia if EVN\>4

Procedure: Group A: Rescue analgesia if NVS>4

Group B

EXPERIMENTAL

Rescue analgesia if EVNm \>4 + FAS C

Procedure: Group B: Rescue analgesia if NVSm > 4 + FAS C

Interventions

Group A: Rescue analgesia if NVS>4 PROCEDURE

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 A

Group B: Rescue analgesia if NVSm > 4 + FAS C PROCEDURE

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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacin Biomedica Galicia Sur: lead

Study Sites (1)

Hospital Álvaro Cunqueiro

Vigo, 36211, Spain

RECRUITING

MeSH Terms

Conditions

Agnosia; Pain, Postoperative; Acute Pain

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

Central Study Contacts

Gustavo Illodo Miramontes, MD

CONTACT

986811111; gustavo.illodo.miramontes@sergas.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blind for the data analyzer in which the patients of the scheduled surgeries selected in the selection criteria will be included.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)