Prediction Of Post Operative Pain Following Arthroscopic Shoulder Surgery

NCT ID: NCT01351363

Last Updated: 2011-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Arthroscopic Shoulder Surgery Pain Threshold

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Electrical pain threshold measrement patients

Group Type EXPERIMENTAL

Electrical pain threshold measurement

Intervention Type DEVICE

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

Measurement of electrical pain threshold

Intervention Type DEVICE

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

Interventions

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Electrical pain threshold measurement

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

Intervention Type DEVICE

Measurement of electrical pain threshold

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

Intervention Type DEVICE

Other Intervention Names

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Pain Matcher ® (Cefar Medical AB, Lund, Sweden) Pain Matcher ® (Cefar Medical AB, Lund, Sweden)

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NHS Fife

OTHER_GOV

Sponsor Role lead

Responsible Party

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NHS Fife

Principal Investigators

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Anthony Davis, MBChB

Role: PRINCIPAL_INVESTIGATOR

NHS Fife

Locations

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Victoria Hospital

Kirkcaldy, Fife, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 24358863 (View on PubMed)

Other Identifiers

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SHLDR1

Identifier Type: -

Identifier Source: org_study_id

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