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

July 29, 2025 updated by: University Hospital Plymouth NHS Trust

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.

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 Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7839

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Devon
      • Plymouth, Devon, United Kingdom
        • University Hospitals Plymouth NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults undergoing day-case surgery in the UK

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 months
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)
1 week
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)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
To describe the acute pain experience and analgesia use in the first postoperative week
Time Frame: 1 week
BPI (brief pain inventory) score on days 1, 3, 7; analgesia medication use on days 1, 3, 7
1 week
To estimate the need for further healthcare support in the first postoperative week
Time Frame: 1 week
Yes/no question on questionnaire on day 7
1 week
To determine the patient reported acceptability of SMS prompted follow-up
Time Frame: 1 week
Acceptability question on questionnaire on day 7
1 week
To determine the difference in quality of life between participants with and without PPSP
Time Frame: 3 months
PHQ-8 Score; GAD-7 Score; EQ-5D-5L score at day 97
3 months
To investigate the difficulty in reducing opioid use in participants with PPOU
Time Frame: 3 months
Yes/no question on questionnaire at day 97
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 4-5 months
Semi-structured questionnaires after day 97, regarding the topics listed above
4-5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Mark Rockett, MBBS, PhD, University Hospitals Plymouth NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Actual)

February 9, 2024

Study Completion (Actual)

July 1, 2025

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 23/SED/793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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