PainPOPPYNCT06008496
Patient Reported Outcomes, Postoperative Pain and Pain Relief After Day Case Surgery (POPPY)
An observational study of Pain and Post Operative Pain, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Post Operative Pain, Opioid Use
- What is being tested?
- Day case surgery
- Type of treatment
- Surgery or procedure
- How many people
- 7,839 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2024to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults undergoing day-case surgery in the UK
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Plymouth NHS Trust
Plymouth, Devon
About this study
Official title: The POPPY Study: Patient Reported Outcomes, Postoperative Pain and Pain Relief After Day Case Surgery
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.
Read more
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.
- Conditions
- Pain, Post Operative Pain, Opioid Use, Chronic Pain
- Being tested
- Day case surgery
- Medical subject headings
- Pain, Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day case surgeryProcedure or surgery
Operation, surgical group, magnitude of surgery, anaesthetic type.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
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)
Measured: 1 week
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)
Measured: 3 months
Secondary outcomes (6)
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.
Measured: 3 months
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
Measured: 1 week
To estimate the need for further healthcare support in the first postoperative week
Yes/no question on questionnaire on day 7
Measured: 1 week
To determine the patient reported acceptability of SMS prompted follow-up
Acceptability question on questionnaire on day 7
Measured: 1 week
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
Measured: 3 months
To investigate the difficulty in reducing opioid use in participants with PPOU
Yes/no question on questionnaire at day 97
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start15 Jan 2024
- Primary completion9 Feb 2024
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,839 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Academic Anaesthesia, Newcastle PROMS, Research and Audit Federation of Anaesthetic Trainees (RAFT), University of Plymouth
- Responsible party
- Sponsor
- Investigators
- Mark Rockett, MBBS, PhD, Study director, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008496
- Sponsor's protocol ID
- 23/SED/793
- Acronym
- POPPY
- Status last verified
- Jul 2025
- First submitted
- 2 May 2023
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The POPPY Study: Patient Reported Outcomes, Postoperative Pain and Pain Relief After Day Case Surgery
- ClinicalTrials.gov ID
- NCT06008496
- Acronym / sponsor ID
- POPPY / 23/SED/793
- Conditions
- Pain, Post Operative Pain, Opioid Use, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,839 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Academic Anaesthesia, Newcastle PROMS, Research and Audit Federation of Anaesthetic Trainees (RAFT), University of Plymouth
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing day-case surgery in the UK
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Day case surgeryOperation, surgical group, magnitude of surgery, anaesthetic type. | Procedure or surgery | – |
Primary outcome
To measure short and long-term patient reported outcomes in UK day-case surgery patients.
Time frame: 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
Time frame: 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.
Time frame: 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)
6 secondary outcomes
To identify those patient, medication, anaesthetic, and surgical characteristics that are associated with poor quality of recovery, and PPSP and/or PPOU
Time frame: 3 months
To describe the acute pain experience and analgesia use in the first postoperative week
Time frame: 1 week
To estimate the need for further healthcare support in the first postoperative week
Time frame: 1 week
To determine the patient reported acceptability of SMS prompted follow-up
Time frame: 1 week
To determine the difference in quality of life between participants with and without PPSP
Time frame: 3 months
To investigate the difficulty in reducing opioid use in participants with PPOU
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Study website with latest study documents.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Rockett, MBBS, PhD study director
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Post Operative Pain, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure short and long-term patient reported outcomes in UK day-case surgery patients. (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.