Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07310953

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.

Led by Fundacin Biomedica Galicia Sur · Updated on 2026-02-18

76

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating postoperative pain management in patients undergoing scheduled surgery with video-assisted thoracoscopic surgery (VATS) admission. The study aims to compare two methods for deciding when rescue analgesia is needed: the traditional Numerical Verbal Scale (NVS) versus a new combined Pain and Functional Activity Scale (PFAS) that includes functional limitations. This randomized, single-blind study focuses on acute postoperative pain and functional activity to improve recovery and avoid overtreatment with opioids. Participants are assigned to one of two groups. Group A receives rescue analgesia based on NVS scores greater than 4, while Group B receives analgesia if pain during movement (NVSm) is greater than 4 and there is severe functional limitation (FAS grade C). Rescue analgesia is self-administered using morphine patient-controlled analgesia (PCA) at a maximum dose of 0.075 mg/kg every 15 minutes, up to three times per hour. The intervention period covers the first two days after surgery. During the study, participants will be assessed before surgery and at 24 and 48 hours postoperatively using pain scales (NVS, mNVS, FAS), cognitive tests (Pfeiffer questionnaire), confusion assessments (CAM), and monitoring of analgesia side effects. Researchers will also collect data on demographics, surgery details, anesthesia, analgesia guidelines, nighttime rest, patient satisfaction, and desire for more analgesia. The primary measurements focus on pain and functional activity to evaluate rescue analgesia needs during the early postoperative period.

CONDITIONS

Brief 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.

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled surgery with VATS admission
  • Age over 18 years
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Cognitive-mental deficit assessed by the Pfeiffer questionnaire with more than two errors for university graduates or more than three errors otherwise
  • Allergy to any listed analgesic drugs such as Paracetamol, NSAIDs, Metamizole, Dexamethasone, Local anesthetics, Morphine, or Fentanyl
  • Presence of any functional limitation before surgery according to the FAS scale (Grade B or C)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day 0 to Day 1

Participants undergo scheduled surgery and begin postoperative care including monitoring and management of acute pain.

1 visit on surgery day and 1 visit on the following day

Treatment

Duration - Up to 48 hours post-surgery

Participants self-administer rescue analgesia using morphine PCA based on their assigned pain assessment criteria to manage moderate to severe postoperative pain.

Assessments and analgesia use at 24 and 48 hours, and additional assessments if rescue analgesia is requested

Trial Site Locations

Total: 1 location

1

Hospital Álvaro Cunqueiro

Vigo, Spain, 36211

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Research Team

G

Gustavo Illodo Miramontes, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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