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NCT Number: NCT02004431

Peri-operative Psychology and Post-operative Pain Study

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.

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Key information

Conditions

Surgery Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All inpatients on Sharp, Shaugh or Stannon ward following elective orthopaedic surgery carried out on Monday to Thursday each week.

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Acute pain (NRS) will be measured on day 1 after surgery.

    Time frame: 24 hours

    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

  2. Acute post operative pain (NRS) at 6 months

    Time frame: 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).

  3. Pre operative strong opioid use (binary variable)

    Time frame: 24 hours

    To test any association between pre-operative strong opioid use and acute or chronic post surgical pain and continued opioid use at 6 months.

  4. Total opioid intake before surgery

    Time frame: 24 hours

    Correlation between acute anxiety, depression or catastrophising and total opioid intake before and 1 day & 6 months after surgery

  5. Somatic symptoms questionnaire (bespoke questionnaire)

    Time frame: 24 hours

    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.

  6. Perception of care questionnaire (bespoke questionnaire)

    Time frame: 24 hours

    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

  7. Anxiety (GAD7) will be measured on day 1 after surgery.

    Time frame: 24 hours

    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

  8. Depression (PHQ9) will be measured on day 1 after surgery.

    Time frame: 24 hours

    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

  9. Catastrophising (PCS - pain catastrophising scale) will be measured on day 1

    Time frame: 24 hours

    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

  10. Acute anxiety (GAD7)

    Time frame: 6 months

    Acute pain, anxiety & depression will be measured in day 1 post operatively and correlated with quality of life at 6 months (EQ5D)

  11. Depression (PHQ9)

    Time frame: 6 months

    Acute pain, anxiety & depression will be measured in day 1 post operatively and correlated with quality of life at 6 months (EQ5D)

  12. Quality of life (EQ5D)

    Time frame: 6 months

    Acute pain, anxiety & depression will be measured in day 1 post operatively and correlated with quality of life at 6 months (EQ5D)

  13. Opioid use at 6 months (binary variable)

    Time frame: 6 months

    To test any association between pre-operative strong opioid use and acute or chronic post surgical pain and continued opioid use at 6 months.

  14. Total opioid intake on day 1 post surgery

    Time frame: 24 hours

    Correlation between acute anxiety, depression or catastrophising and total opioid intake before and 1 day & 6 months after surgery

  15. Length of hospital stay (days)

    Time frame: 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

  16. Catastrophising (PCS - pain catastrophising scale)

    Time frame: 6 months

    Acute pain, anxiety & depression will be measured in day 1 post operatively and correlated with quality of life at 6 months (EQ5D)

Sponsors and collaborators

Lead sponsor

University Hospital Plymouth NHS Trust

Other

Registry information

Official study title

A Case-control Study of Peri-operative Psychological State and Acute and Chronic Post-operative Pain

Acronym: 4P

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 9, 2013
Registry last updated
Nov 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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