Using a number-based pain score plus a simple activity score to guide rescue pain medicine after surgery
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.
NA · Fundacin Biomedica Galicia Sur · NCT07310953
This project will test whether using a combined numerical pain score and a simple Functional Activity Score to decide when to give rescue pain medicine helps adults recover after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacin Biomedica Galicia Sur (other) |
| Locations | 1 site (Vigo) |
| Trial ID | NCT07310953 on ClinicalTrials.gov |
What this trial studies
Adults undergoing surgery are randomized to two approaches for rescue analgesia: Group A receives rescue medication when the Numerical Verbal Scale (NVS) is greater than 4, while Group B receives rescue medication only when the NVS is >4 together with a Functional Activity Score (FAS) of C (unable to perform any activity), implementing the proposed Pain and Functional Activity Scale (PFAS). The trial compares how these rules affect the frequency of rescue analgesia, opioid consumption, pain-related functional limitation, and early postoperative recovery. The PFAS combines numeric pain intensity and bedside functional limitation to guide therapeutic decisions at the bedside. Outcomes focus on matching analgesic treatment to functional need and avoiding overtreatment.
Who should consider this trial
Good fit: Adults over 18 scheduled for surgery with VATS admission at the study hospital who can give informed consent and have no preoperative functional limitation or significant cognitive impairment are ideal candidates.
Not a fit: Patients with preoperative functional limitation (FAS B or C), cognitive impairment, allergies to the listed analgesics, or those treated outside the trial center are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could reduce unnecessary opioid use, better match pain medication to patients' functional needs, and support faster mobilization and recovery.
How similar studies have performed: Some observational work and guideline proposals support function-based pain management to reduce overtreatment, but randomized evidence for the combined PFAS approach is limited and the specific PFAS method is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Vigo
- Hospital Álvaro Cunqueiro — Vigo, Spain (RECRUITING)
Study contacts
- Study coordinator: Gustavo Illodo Miramontes, MD
- Email: gustavo.illodo.miramontes@sergas.es
- Phone: 986811111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Analgesia, Post Operative Pain, Acute Pain, Functional, Anesthesia, numerical verbal scale, Functional Activity Score