- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06008496
Patient Reported Outcomes, Postoperative Pain and Pain Relief After Day Case Surgery (POPPY) (POPPY)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Devon
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Plymouth, Devon, United Kingdom
- University Hospitals Plymouth NHS Trust
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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).
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3 months
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Short-term: to describe the quality of recovery over the first postoperative week
Time Frame: 1 week
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QOR-15 score (quality of recovery-15 score); BPI (brief pain inventory) derived pain scores; FPS (functional pain score)
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1 week
|
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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)
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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.
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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
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1 week
|
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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
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1 week
|
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To determine the patient reported acceptability of SMS prompted follow-up
Time Frame: 1 week
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Acceptability question on questionnaire on day 7
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1 week
|
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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
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3 months
|
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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
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Semi-structured questionnaires after day 97, regarding the topics listed above
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4-5 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Mark Rockett, MBBS, PhD, University Hospitals Plymouth NHS Trust
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23/SED/793
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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