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OpenTrials
Completed

NCT Number: NCT01351363

Prediction Of Post Operative Pain Following Arthroscopic Shoulder Surgery

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.

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Key information

Conditions

Arthroscopic Shoulder Surgery Pain Threshold

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Victoria Hospital

Kirkcaldy, Fife, KY2 5AH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Electrical pain threshold measurement

Device

Assessment of preoperative pain threshold using electrical stimulation using a Painmatcher machine.

Other names: Pain Matcher ® (Cefar Medical AB, Lund, Sweden)

Measurement of electrical pain threshold

Device

Measurement of preoperative electrical pain threshold and self reporting of postoperative pain scores (for 4 days) on VAS.

Other names: Pain Matcher ® (Cefar Medical AB, Lund, Sweden)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

NHS Fife

Other Gov

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 10, 2011
Registry last updated
May 10, 2011

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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