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| ID | Type | Description | Link |
|---|---|---|---|
| 2025/306 | Other Identifier | Galician Ethics Committee for Medicinal Products (CEIm-G) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Rescue analgesia if EVN>4 |
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| Group B | Experimental | Rescue analgesia if EVNm >4 + FAS C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Day 0 (before the surgical intervention), at 24 and 48 hours and in case rescue analgesia is requested. |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Patient age in years | Day 0 (before the surgical intervention) |
| Gender | Patient gender (Female, Male) | Day 0 (before the surgical intervention) |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gustavo Illodo Miramontes, MD | Contact | 986811111 | 16246 | gustavo.illodo.miramontes@sergas.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Álvaro Cunqueiro | Recruiting | Vigo | 36211 | Spain |
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Single blind for the data analyzer in which the patients of the scheduled surgeries selected in the selection criteria will be included.
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| 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. |
|
| BMI | Patient body mass index | Day 0 (before the surgical intervention) |
| Pfeiffer | Cognitive-mental deficit assessed according to the Pfeiffer questionnaire: 1. 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. | 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 | 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):
| Day 0 (before the surgical intervention) |
| Procedure | Surgical procedure, indicate one of the following options: Upper lobectomy, Middle lobectomy, Lower lobectomy. | Day 1 (after the surgical intervention) |
| Surgery location | Surgery location, indicate one of the following options: Right, Left. | Day 1 (after the surgical intervention) |
| Anesthetic technique | Anesthetic technique, indicate one of the following options: Inhalational general anesthesia, Intravenous general anesthesia | Day 1 (after the surgical intervention) |
| Intraoperative analgesia guidelines | Intraoperative analgesia guidelines, choose the type of drug: Fentanyl, paracetamol, NSAIDs | Day 1 (after the surgical intervention) |
| Confusión Assessment Method (CAM) | Postoperative Neurological Status of the Patient by Confusión Assessment Method:
1. 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. | at 24 and 48 hours |
| Analgesia guidelines in the post-surgical intensive care unit | Analgesia guidelines in the post-surgical intensive care unit, indicate
| at 24 and 48 hours |
| Side effects of analgesia | Side effects of analgesia, indicate from the following options:
| 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). | at 24 and 48 hours |
| Desire for more analgesia | Desire for more pain relief than received (Yes, No, Don't know) | at 48 hours |
| Satisfaction with pain management therapy | Satisfaction with pain management therapy using 4 categories:
| at 48 hours |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
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