Clinical trial NCT01621555: Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery
Official title: Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anomaly; Shoulder
Keywords: shoulder surgery
Pain sensitivity
Rowe score
Constant Score
Surgical Outcome
Postoperative pain
Lead sponsor: NHS Fife
Sponsor class: OTHER_GOV
First posted: 2012-06-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for elective arthroscopic shoulder surgery

Brief summary: The purpose of this study is to investigate whether there is a correlation between a patients pain sensitivity and their subsequent post-operative pain and surgical outcome in arthroscopic shoulder surgery.

Detailed description: Arthroscopic shoulder surgery is increasingly performed on a daycase basis. Optimal pain relief is the goal as this not only improves patient comfort and allows expedient discharge from hospital, but also reduces the risk of developing postoperative chronic pain and may improve surgical outcome. However, optimal postoperative pain control in daycase surgery remains a challenge. There is considerable variation in the level of postoperative pain experienced between individuals and subsequent analgesia requirements. Previous studies have attempted to predict the level of postoperative pain an individual will experience, using a variety of complex preoperative pain and psychological assessments. Other investigators have focused on a simpler approach, by testing an individual's pain threshold to a single preoperative nociceptive (painful) stimulus, e.g. heat or pressure. Recent work has produced a simple questionnaire alternative to pain intensity testing, the Pain Sensitivity Questionnaire (PSQ). We hypothesise that a patient's pain sensitivity preoperatively may both affect the level of pain they experience postoperatively and their final surgical outcome.

The aim of our study is to correlate a patient's pain sensitivity, as measured by the Pain Sensitivity Questionnaire, with the degree of acute postoperative pain (first 4 days) they experience and subsequent surgical outcome at 6 months.

Eligibility criteria: Inclusion Criteria:

All patients aged 18 years or older, attending for arthroscopic shoulder surgery (stabilisation, rotator cuff repair, arthrolysis, subacromial decompression), able to give informed consent.

Exclusion Criteria:

* Unable to give informed consent
* Documented sensory abnormality (e.g. peripheral neuropathy)
* Contraindication to proposed anaesthetic/analgesic regimen
* No telephone or unable to communicate in English
* Documented psychiatric disorder
* Documented/suspected substance abuse

Primary outcomes:
measure: Degree of correlation between Pain Sensitivity Questionnaire score and 6 month postoperative Rowe/Constant Score.
timeFrame: 6 months
Secondary outcomes:
measure: The degree of correlation between Pain Sensitivity Questionnaire scores and 'Area Under the Curve (AUC)' for postoperative pain experienced (generated from the VAS scores over 4 postoperative days).
timeFrame: 6 months
measure: • The degree of correlation between AUC for postoperative pain and 6 month Constant/Rowe score.
timeFrame: 6 months
Other outcomes:
Locations:
city: Kirkcaldy
country: United Kingdom
facility: NHS FIFE
state: Fife
Study officials:
affiliation: NHS Fife
name: ANTHONY H DAVIS, MBCHB FRCA
role: PRINCIPAL_INVESTIGATOR
References: