Patient Reported Outcomes, Postoperative Pain and Pain Relief After Day Case Surgery (POPPY)

Pain Clinical Trial

— POPPY  

Official title:

The POPPY Study: Patient Reported Outcomes, Postoperative Pain and Pain Relief After Day Case Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008496
• Other study ID #: 23/SED/793
• Status: Recruiting
• Start date: January 15, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: August 2023
• Source: University Hospital Plymouth NHS Trust
• Contact: Matthew Everson, MBBS, FRCA
• Phone: 07749410572
• Email: matthew.everson[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: February 1, 2025
• Est. primary completion date: May 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use
• Pain
• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Day case surgery
Operation, surgical group, magnitude of surgery, anaesthetic type.

Locations

Country	Name	City	State
United Kingdom	University Hospitals Plymouth NHS Trust	Plymouth	Devon

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital Plymouth NHS Trust	National Institute for Academic Anaesthesia, Newcastle PROMS, Research and Audit Federation of Anaesthetic Trainees (RAFT), University of Plymouth

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To explore patient experience of; Preparation for day case surgery and pre-operative expectations Acute recovery (first postoperative week) Longer-term recovery and post-operative pain (after 3 months) Opioids: intake, type, duration and experience.	Semi-structured questionnaires after day 97, regarding the topics listed above	4-5 months
Primary	To measure short and long-term patient reported outcomes in UK day-case surgery patients.	See below outcomes for specifics (this is an overarching outcome which is broken down in the outcomes described below).	3 months
Primary	Short-term: to describe the quality of recovery over the first postoperative week	QOR-15 score (quality of recovery-15 score); BPI (brief pain inventory) derived pain scores; FPS (functional pain score)	1 week
Primary	Long-term: to establish the prevalence of persistent postsurgical pain (PPSP) and persistent postoperative opioid use (PPOU) in day case surgical patients.	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)	3 months
Secondary	To identify those patient, medication, anaesthetic, and surgical characteristics that are associated with poor quality of recovery, and PPSP and/or PPOU	Baseline data collection: age, sex, operation type, anaesthetic type, baseline medications and medication use on day 1, 3, 7 and 97 post-op. Medication use recorded as frequency of use and medication type.	3 months
Secondary	To describe the acute pain experience and analgesia use in the first postoperative week	BPI (brief pain inventory) score on days 1, 3, 7; analgesia medication use on days 1, 3, 7	1 week
Secondary	To estimate the need for further healthcare support in the first postoperative week	Yes/no question on questionnaire on day 7	1 week
Secondary	To determine the patient reported acceptability of SMS prompted follow-up	Acceptability question on questionnaire on day 7	1 week
Secondary	To determine the difference in quality of life between participants with and without PPSP	PHQ-8 Score; GAD-7 Score; EQ-5D-5L score at day 97	3 months
Secondary	To investigate the difficulty in reducing opioid use in participants with PPOU	Yes/no question on questionnaire at day 97	3 months

External Links

•   Study website with latest study documents.