Hospital Álvaro Cunqueiro
Vigo, 36211, Spain
Location status: Recruiting
Location contact
Gustavo Illodo Miramontes
CONTACT
NCT Number: NCT07310953
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Vigo, 36211, Spain
Location status: Recruiting
Gustavo Illodo Miramontes
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Withdrawal Criteria:
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.
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.
Time frame: Day 0 (before the surgical intervention), at 24 and 48 hours and in case rescue analgesia is requested.
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.
Time frame: Day 0 (before the surgical intervention), at 24 and 48 hours and in case rescue analgesia is requested.
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.
Time frame: Day 0 (before the surgical intervention), at 24 and 48 hours and in case rescue analgesia is requested.
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:
Time frame: Day 0 (before the surgical intervention)
Patient age in years
Time frame: Day 0 (before the surgical intervention)
Patient gender (Female, Male)
Time frame: Day 0 (before the surgical intervention)
Patient body mass index
Time frame: Day 0 (before the surgical intervention)
Cognitive-mental deficit assessed according to the Pfeiffer questionnaire:
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.
Time frame: Day 0 (before the surgical intervention)
Anesthetic risk scale (ASA), indicate one of the following options: 0-No risk, 1-Low risk, 2-Moderate risk, 3-High risk
Time frame: Day 0 (before the surgical intervention)
Risk factors associated with persistent postoperative pain, indicate the following option(s):
Time frame: Day 1 (after the surgical intervention)
Surgical procedure, indicate one of the following options: Upper lobectomy, Middle lobectomy, Lower lobectomy.
Time frame: Day 1 (after the surgical intervention)
Surgery location, indicate one of the following options: Right, Left.
Time frame: Day 1 (after the surgical intervention)
Anesthetic technique, indicate one of the following options: Inhalational general anesthesia, Intravenous general anesthesia
Time frame: Day 1 (after the surgical intervention)
Intraoperative analgesia guidelines, choose the type of drug: Fentanyl, paracetamol, NSAIDs
Time frame: at 24 and 48 hours
Postoperative Neurological Status of the Patient by Confusión Assessment Method:
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.
Time frame: at 24 and 48 hours
Analgesia guidelines in the post-surgical intensive care unit, indicate
Time frame: at 24 and 48 hours
Side effects of analgesia, indicate from the following options:
Time frame: at 24 and 48 hours
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).
Time frame: at 48 hours
Desire for more pain relief than received (Yes, No, Don't know)
Time frame: at 48 hours
Satisfaction with pain management therapy using 4 categories:
Contact information is provided by the study sponsor or research team.
Fundacin Biomedica Galicia Sur
Other
Acronym: EVN/EDAF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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