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Clinical Trials/NCT01351363
NCT01351363
Completed
Not Applicable

PREDICTION OF POST OPERATIVE PAIN FOLLOWING ARTHROSCOPIC SHOULDER SURGERY

NHS Fife1 site in 1 country43 target enrollmentMarch 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthroscopic Shoulder Surgery
Sponsor
NHS Fife
Enrollment
43
Locations
1
Primary Endpoint
Post operative pain level
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

Following arthroscopic shoulder surgery a small but significant number of people suffer severe postoperative pain.

This study aims to predict which patients are at risk of developing severe post operative pain so that they may be targeted with a more aggressive post operative pain regimen.

Detailed Description

Patients presenting for elective (day case) arthroscopic shoulder surgery for either Arthroscopic Subacromial Decompression (ASD Group) or Rotator Cuff Repair (RCR Group) are recruited. Using a Cefar PainMatcher, a pain and sensory threshold assessment tool, consenting patients will have their preoperative pain thresholds recorded. The patients will then have a standard anaesthetic administered with TIVA (propofol/remifentanil) and either a subacromial injection (ASD Group) or interscalene block (RCR Group). Four days following surgery a telephone questionnaire will be completed by the patients recording their worst pain score since surgery.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
May 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
NHS Fife

Eligibility Criteria

Inclusion Criteria

  • All patients aged 18 years or older able to give informed consent undergoing arthroscopic shoulder surgery at NHS Fife (ASD or rotator cuff repair)

Exclusion Criteria

  • Unable to give informed consent
  • Allergy to remifentanil, propofol or levobupivacaine.
  • Absence of contralateral arm (thumb/fingers)
  • Documented sensory abnormality (e.g. peripheral neuropathy)
  • Those not consenting to subacromial injection or interscalene block intraopertively (part of routine management after surgery).
  • Psychiatric disease (documented history in Hospital notes or GP referral summary)
  • Drug or alcohol misuse (suspicion of or documented)
  • No telephone or unable to communicate in English (no interpreter service available)

Outcomes

Primary Outcomes

Post operative pain level

Time Frame: 4 days

Post operative pain level recorded on a VAS (0-10) at rest and movement for the first four days pots shoulder surgery. This information will be correlated with the preoperative pain threshold of patients taken with the Pain matcher machine.

Study Sites (1)

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