Clinical trial NCT06008496: Patient Reported Outcomes, Postoperative Pain and Pain Relief After Day Case Surgery (POPPY)
Official title: The POPPY Study: Patient Reported Outcomes, Postoperative Pain and Pain Relief After Day Case Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain
Post Operative Pain
Opioid Use
Chronic Pain
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Academic Anaesthesia
name: Newcastle PROMS
name: Research and Audit Federation of Anaesthetic Trainees (RAFT)
name: University of Plymouth
First posted: 2023-08-23
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing day-case surgery in the UK

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: To measure short and long-term patient reported outcomes in UK day-case surgery patients.
timeFrame: 3 months
measure: Short-term: to describe the quality of recovery over the first postoperative week
timeFrame: 1 week
measure: Long-term: to establish the prevalence of persistent postsurgical pain (PPSP) and persistent postoperative opioid use (PPOU) in day case surgical patients.
timeFrame: 3 months
Secondary outcomes:
measure: To identify those patient, medication, anaesthetic, and surgical characteristics that are associated with poor quality of recovery, and PPSP and/or PPOU
timeFrame: 3 months
measure: To describe the acute pain experience and analgesia use in the first postoperative week
timeFrame: 1 week
measure: To estimate the need for further healthcare support in the first postoperative week
timeFrame: 1 week
measure: To determine the patient reported acceptability of SMS prompted follow-up
timeFrame: 1 week
measure: To determine the difference in quality of life between participants with and without PPSP
timeFrame: 3 months
measure: To investigate the difficulty in reducing opioid use in participants with PPOU
timeFrame: 3 months
Other outcomes:
measure: 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.
timeFrame: 4-5 months
Locations:
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
state: Devon
Study officials:
affiliation: University Hospitals Plymouth NHS Trust
name: Mark Rockett, MBBS, PhD
role: STUDY_DIRECTOR
References: