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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- NVS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single blind for the data analyzer in which the patients of the scheduled surgeries selected in the selection criteria will be included.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scheduled surgery with VATS admission
- •Age > 18 years
- •Signed informed consent
排除标准
- •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.
研究组 & 干预措施
Group A
Rescue analgesia if EVN>4
干预措施: Group A: Rescue analgesia if NVS>4 (Procedure)
Group B
Rescue analgesia if EVNm >4 + FAS C
干预措施: Group B: Rescue analgesia if NVSm > 4 + FAS C (Procedure)
结局指标
主要结局
NVS
时间窗: 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.
mNVS
时间窗: 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.
FAS
时间窗: 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: * A: Able to perform any activity (performs all 4 activities without limitation) * B: Pain prevents some activity (unable to perform between 1 and 3 of the activities) * C: Unable to perform any activity (is unable to perform any of the activities)
次要结局
- Age(Day 0 (before the surgical intervention))
- Gender(Day 0 (before the surgical intervention))
- BMI(Day 0 (before the surgical intervention))
- Pfeiffer(Day 0 (before the surgical intervention))
- ASA(Day 0 (before the surgical intervention))
- Risk factors associated with persistent postoperative pain(Day 0 (before the surgical intervention))
- Procedure(Day 1 (after the surgical intervention))
- Surgery location(Day 1 (after the surgical intervention))
- Anesthetic technique(Day 1 (after the surgical intervention))
- Intraoperative analgesia guidelines(Day 1 (after the surgical intervention))
- Confusión Assessment Method (CAM)(at 24 and 48 hours)
- Analgesia guidelines in the post-surgical intensive care unit(at 24 and 48 hours)
- Side effects of analgesia(at 24 and 48 hours)
- Nighttime rest(at 24 and 48 hours)
- Desire for more analgesia(at 48 hours)
- Satisfaction with pain management therapy(at 48 hours)