Surgery4PNCT02004431
Peri-operative Psychology and Post-operative Pain Study
An observational study of Surgery and Pain, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
The experience of pain is common among hospital inpatients. Orthopaedic surgery often results in significant pain, which may last for some time. About one in eight people will experience long-term or chronic pain after surgery, which can impact on quality of life and mood. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Oct 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of all patients following elective orthopaedic surgery with a planned inpatient stay of at least 24 hours
Who may be able to join
- All inpatients on Sharp, Shaugh or Stannon ward following elective orthopaedic surgery carried out on Monday to Thursday each week.
Who cannot join
- Patient refusal, Age <18, Emergency / trauma surgery, Day case surgery, unable to read or understand written instructions, No contact address, Not registered with a General Practitioner (GP)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8DH
About this study
Official title: A Case-control Study of Peri-operative Psychological State and Acute and Chronic Post-operative Pain
The experience of pain is common among hospital inpatients. Orthopaedic surgery often results in significant pain, which may last for some time. About one in eight people will experience long-term or chronic pain after surgery, which can impact on quality of life and mood. Some risk factors are known for chronic post surgical pain (CPSP) and these include patient factors, surgical factors and anaesthetic factors. We know that mood problems (anxiety and depression) increase the risk of CPSP. What is not known is how short term changes in mood are related to the experience of pain after surgery and how this impacts on CPSP. This study is designed to investigate the relationship between both short and long-term mood problems and short and long-term pain and quality of life after orthopaedic surgery. The study will provide valuable information to allow us to design a psychological intervention, which might reduce the risk of short-term post surgical pain and CPSP.
This study also aims to measure a number of other variables, which may be related to CPSP including medication use, other medically unexplained symptoms and catastrophic thinking in response to pain.
Read more
All patients having planned orthopaedic surgery will be asked to enter the trial. Those consenting to involvement will complete a questionnaire assessing the variables described above. They will be divided into two groups depending on whether they have significant pain on the day after their surgery. As the primary aim of the study, the rates of significant anxiety or depression will then be compared between these two groups.
Secondary outcomes will be assessed by a questionnaire sent to the patients at 6 months after their surgery. Descriptive statistics will be produced for all the variables and use to model a future study, which would assess the effect of a psychological intervention on acute and chronic post surgical pain.
Our hypothesis is that patients are more likely to experience acute anxiety and depression or display catastrophic thinking if they suffer significant post-surgical pain. The study is powered to reliably detect a three-fold difference in the prevalence of psychopathology between patients with and without acute pain on day 1 after elective orthopaedic surgery.
Read the detailed description
This is a prospective case-control observational study. The primary aim is to determine whether patients with poor pain control on day 1 following surgery have higher levels of anxiety / depression or catastrophising than those without acute pain. The cases are patients with significant pain on day one after surgery and the controls are sex, age and operation matched individuals without pain.
Several other variables are measured which may provide information for the design of future studies. The presence of pain or psychopathology prior to surgery will be recorded, as this is likely to impact on these variables in the post-operative period. Analgesic use pre and post surgery is also of interest as a surrogate measure of pain severity.
In addition to day one data, pain severity will also be recorded on day 2 and 3 post-operatively. This is of interest as although most patients will be expected to demonstrate reducing pain severity with time, a proportion will not improve and a small number will experience increasing pain with time. This adverse "pain trajectory" might be associated with an increased incidence of CPSP 28.
Long-term outcomes such as pain and quality of life at 6 months post-discharge will also be assessed by postal questionnaire.
The eventual aim of this series of studies is to assess the interaction between acute psychological problems and post-surgical pain and the impact that this has on longer-term outcomes such as CPSP, mood and quality of life. Short-term pre- and post-operative psychological interventions will then be developed to modify the impact of psychological factors on long-term surgical outcomes. Further studies will assess the efficacy of these interventions. Pre-study audit will be carried out to confirm the feasibility of matching.
- Conditions
- Surgery, Pain, Anxiety, Depression
- Keywords
- Chronic post surgical pain, Orthopaedic, Anxiety, depression
- Medical subject headings
- Pain, Anxiety Disorders, Depression, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pain (experimental) | The cases are patients with significant pain on day one after surgery | |
| No pain (control) | The controls are sex, age and operation matched individuals without pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is acute pain following orthopaedic surgery is associated with the onset of anxiety as measured using the Generalised Anxiety Disorder Questionnaire (GAD-7)
This is a prospective case-control observational study. The primary aim is to determine whether patients with poor pain control on day 1 following surgery have higher levels of anxiety than those without acute pain. The cases are patients with significant pain on day one after surgery and the controls are sex, age and operation matched individuals without pain.
Measured: 24 hours
Is acute pain following orthopaedic surgery is associated with the onset of depression as measured using the Patient Health Questionnaire (PHQ-9).
This is a prospective case-control observational study. The primary aim is to determine whether patients with poor pain control on day 1 following surgery have higher levels of depression than those without acute pain. The cases are patients with significant pain on day one after surgery and the controls are sex, age and operation matched individuals without pain.
Measured: 24 hours
Is acute pain following orthopaedic surgery is associated with the onset of abnormal coping strategies as measured using the Pain Catastrophising Scale (PCS).
This is a prospective case-control observational study. The primary aim is to determine whether patients with poor pain control on day 1 following surgery have higher levels of catastrophising than those without acute pain. The cases are patients with significant pain on day one after surgery and the controls are sex, age and operation matched individuals without pain.
Measured: 24 hours
Secondary outcomes (16)
Acute pain (NRS) will be measured on day 1 after surgery.
Correlation between acute variables (pain, anxiety, depression and catastrophising) will be sought with length of hospital stay and the presence of chronic post surgical pain at 6 months
Measured: 24 hours
Acute post operative pain (NRS) at 6 months
Correlation between acute variables (pain, anxiety, depression and catastrophising) will be sought with length of hospital stay and the presence of chronic post surgical pain at 6 months.
Correlation will be sought between pain immediately after surgery and chronic post surgical pain 6 months later.
Acute pain, anxiety \& depression will be measured in day 1 post operatively and correlated with quality of life at 6 months (EQ5D).
Measured: 6 months
Pre operative strong opioid use (binary variable)
To test any association between pre-operative strong opioid use and acute or chronic post surgical pain and continued opioid use at 6 months.
Measured: 24 hours
Total opioid intake before surgery
Correlation between acute anxiety, depression or catastrophising and total opioid intake before and 1 day \& 6 months after surgery
Measured: 24 hours
Somatic symptoms questionnaire (bespoke questionnaire)
This questionnaire records other somatic symptoms patients may experience and the total score will be used to determine any correlation with acute psychopathology, pain and outcomes following surgery as described above.
Measured: 24 hours
Perception of care questionnaire (bespoke questionnaire)
This questionnaire contains details of the inpatient experience and we will investigate whether patient perceptions of care correlate with psychopathology, pain and outcomes following surgery
Measured: 24 hours
Anxiety (GAD7) will be measured on day 1 after surgery.
Correlation between acute variables (pain, anxiety, depression and catastrophising) will be sought with length of hospital stay and the presence of chronic post surgical pain at 6 months.
PHQ9 \& GAD 7 scores on day 1 after surgery and at 6 months. Presence of treated anxiety or depression before surgery (binary score). The frequency of significant anxiety or depression will be compared before and after surgery
Measured: 24 hours
Depression (PHQ9) will be measured on day 1 after surgery.
Correlation between acute variables (pain, anxiety, depression and catastrophising) will be sought with length of hospital stay and the presence of chronic post surgical pain at 6 months.
PHQ9 \& GAD 7 scores on day 1 after surgery and at 6 months. Presence of treated anxiety or depression before surgery (binary score). The frequency of significant anxiety or depression will be compared before and after surgery
Measured: 24 hours
Catastrophising (PCS - pain catastrophising scale) will be measured on day 1
Correlation between acute variables (pain, anxiety, depression and catastrophising) will be sought with length of hospital stay and the presence of chronic post surgical pain at 6 months
Measured: 24 hours
Acute anxiety (GAD7)
Acute pain, anxiety \& depression will be measured in day 1 post operatively and correlated with quality of life at 6 months (EQ5D)
Measured: 6 months
Depression (PHQ9)
Acute pain, anxiety \& depression will be measured in day 1 post operatively and correlated with quality of life at 6 months (EQ5D)
Measured: 6 months
Quality of life (EQ5D)
Acute pain, anxiety \& depression will be measured in day 1 post operatively and correlated with quality of life at 6 months (EQ5D)
Measured: 6 months
Opioid use at 6 months (binary variable)
To test any association between pre-operative strong opioid use and acute or chronic post surgical pain and continued opioid use at 6 months.
Measured: 6 months
Total opioid intake on day 1 post surgery
Correlation between acute anxiety, depression or catastrophising and total opioid intake before and 1 day \& 6 months after surgery
Measured: 24 hours
Length of hospital stay (days)
Correlation between acute variables (pain, anxiety, depression and catastrophising) will be sought with length of hospital stay and the presence of chronic post surgical pain at 6 months
Measured: Days
Catastrophising (PCS - pain catastrophising scale)
Acute pain, anxiety \& depression will be measured in day 1 post operatively and correlated with quality of life at 6 months (EQ5D)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Rockett, MB ChB, PhD, Principal investigator, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004431
- Sponsor's protocol ID
- 13/P/159
- Other IDs
- 137267
- Acronym
- 4P
- Status last verified
- Sep 2014
- First submitted
- 11 Nov 2013
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study of Peri-operative Psychological State and Acute and Chronic Post-operative Pain
- ClinicalTrials.gov ID
- NCT02004431
- Acronym / sponsor ID
- 4P / 13/P/159
- Conditions
- Surgery, Pain, Anxiety, Depression
- Keywords
- Chronic post surgical pain, Orthopaedic, Anxiety, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Dec 2013 (estimated)
- 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.
The experience of pain is common among hospital inpatients. Orthopaedic surgery often results in significant pain, which may last for some time. About one in eight people will experience long-term or chronic pain after surgery, which can impact on quality of life and mood. Some risk factors are known for chronic post surgical pain (CPSP) and these include patient factors, surgical factors and anaesthetic factors. We know that mood problems (anxiety and depression) increase the risk of CPSP. What is not known is how short term changes in mood are related to the experience of pain after surgery and how this impacts on CPSP. This study is designed to investigate the relationship between both short and long-term mood problems and short and long-term pain and quality of life after orthopaedic surgery. The study will provide valuable information to allow us to design a psychological intervention, which might reduce the risk of short-term post surgical pain and CPSP.
This study also aims to measure a number of other variables, which may be related to CPSP including medication use, other medically unexplained symptoms and catastrophic thinking in response to pain.
All patients having planned orthopaedic surgery will be asked to enter the trial. Those consenting to involvement will complete a questionnaire assessing the variables described above. They will be divided into two groups depending on whether they have significant pain on the day after their surgery. As the primary aim of the study, the rates of significant anxiety or depression will then be compared between these two groups.
Secondary outcomes will be assessed by a questionnaire sent to the patients at 6 months after their surgery. Descriptive statistics will be produced for all the variables and use to model a future study, which would assess the effect of a psychological intervention on acute and chronic post surgical pain.
Our hypothesis is that patients are more likely to experience acute anxiety and depression or display catastrophic thinking if they suffer significant post-surgical pain. The study is powered to reliably detect a three-fold difference in the prevalence of psychopathology between patients with and without acute pain on day 1 after elective orthopaedic surgery.
Detailed description
This is a prospective case-control observational study. The primary aim is to determine whether patients with poor pain control on day 1 following surgery have higher levels of anxiety / depression or catastrophising than those without acute pain. The cases are patients with significant pain on day one after surgery and the controls are sex, age and operation matched individuals without pain.
Several other variables are measured which may provide information for the design of future studies. The presence of pain or psychopathology prior to surgery will be recorded, as this is likely to impact on these variables in the post-operative period. Analgesic use pre and post surgery is also of interest as a surrogate measure of pain severity.
In addition to day one data, pain severity will also be recorded on day 2 and 3 post-operatively. This is of interest as although most patients will be expected to demonstrate reducing pain severity with time, a proportion will not improve and a small number will experience increasing pain with time. This adverse "pain trajectory" might be associated with an increased incidence of CPSP 28.
Long-term outcomes such as pain and quality of life at 6 months post-discharge will also be assessed by postal questionnaire.
The eventual aim of this series of studies is to assess the interaction between acute psychological problems and post-surgical pain and the impact that this has on longer-term outcomes such as CPSP, mood and quality of life. Short-term pre- and post-operative psychological interventions will then be developed to modify the impact of psychological factors on long-term surgical outcomes. Further studies will assess the efficacy of these interventions. Pre-study audit will be carried out to confirm the feasibility of matching.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain (experimental) | – | –The cases are patients with significant pain on day one after surgery |
| No pain (control) | – | –The controls are sex, age and operation matched individuals without pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of all patients following elective orthopaedic surgery with a planned inpatient stay of at least 24 hours
Key inclusion criteria (1 listed)
- All inpatients on Sharp, Shaugh or Stannon ward following elective orthopaedic surgery carried out on Monday to Thursday each week.
Key exclusion criteria (1 listed)
- Patient refusal, Age <18, Emergency / trauma surgery, Day case surgery, unable to read or understand written instructions, No contact address, Not registered with a General Practitioner (GP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Is acute pain following orthopaedic surgery is associated with the onset of anxiety as measured using the Generalised Anxiety Disorder Questionnaire (GAD-7)
Time frame: 24 hours
This is a prospective case-control observational study. The primary aim is to determine whether patients with poor pain control on day 1 following surgery have higher levels of anxiety than those without acute pain. The cases are patients with significant pain on day one after surgery and the controls are sex, age and operation matched individuals without pain.
Is acute pain following orthopaedic surgery is associated with the onset of depression as measured using the Patient Health Questionnaire (PHQ-9).
Time frame: 24 hours
This is a prospective case-control observational study. The primary aim is to determine whether patients with poor pain control on day 1 following surgery have higher levels of depression than those without acute pain. The cases are patients with significant pain on day one after surgery and the controls are sex, age and operation matched individuals without pain.
Is acute pain following orthopaedic surgery is associated with the onset of abnormal coping strategies as measured using the Pain Catastrophising Scale (PCS).
Time frame: 24 hours
This is a prospective case-control observational study. The primary aim is to determine whether patients with poor pain control on day 1 following surgery have higher levels of catastrophising than those without acute pain. The cases are patients with significant pain on day one after surgery and the controls are sex, age and operation matched individuals without pain.
16 secondary outcomes
Acute pain (NRS) will be measured on day 1 after surgery.
Time frame: 24 hours
Acute post operative pain (NRS) at 6 months
Time frame: 6 months
Pre operative strong opioid use (binary variable)
Time frame: 24 hours
Total opioid intake before surgery
Time frame: 24 hours
Somatic symptoms questionnaire (bespoke questionnaire)
Time frame: 24 hours
Perception of care questionnaire (bespoke questionnaire)
Time frame: 24 hours
Anxiety (GAD7) will be measured on day 1 after surgery.
Time frame: 24 hours
Depression (PHQ9) will be measured on day 1 after surgery.
Time frame: 24 hours
Catastrophising (PCS - pain catastrophising scale) will be measured on day 1
Time frame: 24 hours
Acute anxiety (GAD7)
Time frame: 6 months
Depression (PHQ9)
Time frame: 6 months
Quality of life (EQ5D)
Time frame: 6 months
Opioid use at 6 months (binary variable)
Time frame: 6 months
Total opioid intake on day 1 post surgery
Time frame: 24 hours
Length of hospital stay (days)
Time frame: Days
Catastrophising (PCS - pain catastrophising scale)
Time frame: 6 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 5 Nov 2015.
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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, MB ChB, PhD principal investigator
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 Surgery and 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 1 inclusion and 1 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 5 Nov 2015. 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?
Is acute pain following orthopaedic surgery is associated with the onset of anxiety as measured using the Generalised Anxiety Disorder Questionnaire (GAD-7) (time frame: 24 hours). 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 5 Nov 2015.