Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery (PSOASS)

June 14, 2012 updated by: Tony Davis, NHS Fife
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Contact

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting for elective arthroscopic shoulder surgery

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
PSOASS Patients
Patients undergoing elective arthroscopic shoulder surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Degree of correlation between Pain Sensitivity Questionnaire score and 6 month postoperative Rowe/Constant Score.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: 6 months
6 months
• The degree of correlation between AUC for postoperative pain and 6 month Constant/Rowe score.
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

NHS Fife

Investigators

  • Principal Investigator: ANTHONY H DAVIS, MBCHB FRCA, NHS FIFE

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

August 1, 2012

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

June 14, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (Estimate)

June 18, 2012

Study Record Updates

Last Update Posted (Estimate)

June 18, 2012

Last Update Submitted That Met QC Criteria

June 14, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSOASS1

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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