NCT01351363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
Last Updated

May 10, 2011

Status Verified

May 1, 2011

Enrollment Period

2.2 years

First QC Date

May 9, 2011

Last Update Submit

May 9, 2011

Conditions

Keywords

Arthroscopic shoulder surgeryPain threshold

Outcome Measures

Primary Outcomes (1)

  • Post operative pain level

    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.

    4 days

Study Arms (1)

Electrical pain threshold measrement patients

EXPERIMENTAL
Device: Electrical pain threshold measurementDevice: Measurement of electrical pain threshold

Interventions

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

Also known as: Pain Matcher ® (Cefar Medical AB, Lund, Sweden)
Electrical pain threshold measrement patients

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

Also known as: Pain Matcher ® (Cefar Medical AB, Lund, Sweden)
Electrical pain threshold measrement patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Hospital

Kirkcaldy, Fife, KY2 5AH, United Kingdom

Location

Related Publications (1)

  • Davis A, Chinn DJ, Sharma S. Prediction of post-operative pain following arthroscopic subacromial decompression surgery: an observational study. F1000Res. 2013 Feb 4;2:31. doi: 10.12688/f1000research.2-31.v1. eCollection 2013.

Study Officials

  • Anthony Davis, MBChB

    NHS Fife

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 10, 2011

Study Start

March 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 10, 2011

Record last verified: 2011-05

Locations