The POPPY Study: Patient Reported Outcomes, Postoperative Pain and Pain Relief After Day Case Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7,839
- 试验地点
- 1
- 主要终点
- To measure short and long-term patient reported outcomes in UK day-case surgery patients.
研究概览
简要总结
Around 3 out of 4 operations in the UK are performed as day-case, meaning the patient goes home on the same day of their operation. Hospitals usually do not follow up patients after day-case operations so we do not know very much about their short or long-term recovery. Some patients, even those who have had small operations, can develop persistent pain afterwards that continues for a long time (months to years). These patients may end up taking strong painkillers for a long time and this risks serious side effects and long-term health problems.
The POPPY study aims to find out what recovery from day-case operations is like from the patient's point of view. We will look at the first week after patients' operations and then at 3 months to see if they are in pain, and if so what pain relief they are taking.
All adults over the 5-day study period having day-case operations in the UK, with an anaesthetist, will be eligible if they have access to a smartphone. Patients will be recruited on the day of their operation from over 100 NHS hospitals. Some relevant information about the patient's current health, operation and anaesthetic will be recorded from their notes. Afterwards participants will get a text message at days 1, 3 and 7 and the at 3 months. These will connect to a data secure online questionnaire about pain, recovery, and what medications they are taking. A small number of participants with ongoing pain at 3 months will be invited to take part in a structured interview to understand their experience in more depth.
This study will provide important information that may be used to improve care of patients having day-case operations and plan future research studies aimed to prevent persistent pain and long-term use of strong painkillers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older on day of surgery
- •Day-case surgery as defined by National Day Surgery Delivery Pack (NEED REF)
- •An anaesthetist must be present for case.
- •The procedure must involve one or more of: sedation, regional anaesthesia, central neuraxial anaesthesia or general anaesthesia
排除标准
- •Less than 18 years of age on day of surgery
- •No anaesthetist involved with the procedure (such as local anaesthesia provided by a surgeon)
- •Overnight stay (admission to hospital)
- •Participant lacking capacity for consent
- •Diagnostic and/or minimally invasive procedures (e.g., radiology, endoscopy, or cardiology procedures)
- •Pregnancy or obstetric related procedures (pregnancy per-se is not an exclusion criterion).
- •Currently breast feeding
- •Ophthalmic procedures
- •No access to Smartphone and email
- •Prisoners
- •Eligibility for qualitative component:
- •As above, plus reporting PPSP and/or PPOU at day 97 post operative
结局指标
主要结局
To measure short and long-term patient reported outcomes in UK day-case surgery patients.
时间窗: 3 months
See below outcomes for specifics (this is an overarching outcome which is broken down in the outcomes described below).
Short-term: to describe the quality of recovery over the first postoperative week
时间窗: 1 week
QOR-15 score (quality of recovery-15 score); BPI (brief pain inventory) derived pain scores; FPS (functional pain score)
Long-term: to establish the prevalence of persistent postsurgical pain (PPSP) and persistent postoperative opioid use (PPOU) in day case surgical patients.
时间窗: 3 months
PPOU prevalence (from medication use); pain at surgical site questionnaire; GAD-7 Score (generalised anxiety and depression 7 score); EQ-5D-5L score; BPI score; PHQ-8 Score (Patient Health Questionnaire 8)
次要结局
- To estimate the need for further healthcare support in the first postoperative week(1 week)
- To determine the difference in quality of life between participants with and without PPSP(3 months)
- To investigate the difficulty in reducing opioid use in participants with PPOU(3 months)
- To identify those patient, medication, anaesthetic, and surgical characteristics that are associated with poor quality of recovery, and PPSP and/or PPOU(3 months)
- To describe the acute pain experience and analgesia use in the first postoperative week(1 week)
- To determine the patient reported acceptability of SMS prompted follow-up(1 week)