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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. (EVN/EDAF)

F

Fundacin Biomedica Galicia Sur

Status

Active, not recruiting

Conditions

Analgesia
Acute Pain
Functional; Anesthesia
Post Operative Pain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07310953
EVN/EDAF
2025/306 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

76 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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 design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

76 participants in 2 patient groups

Group A
Active Comparator group
Description:
Rescue analgesia if EVN\>4
Treatment:
Procedure: Group A: Rescue analgesia if NVS>4
Group B
Experimental group
Description:
Rescue analgesia if EVNm \>4 + FAS C
Treatment:
Procedure: Group B: Rescue analgesia if NVSm > 4 + FAS C

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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