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Prediction Of Post Operative Pain Following Arthroscopic Shoulder Surgery

Primary Purpose

Arthroscopic Shoulder Surgery, Pain Threshold

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Electrical pain threshold measurement
Measurement of electrical pain threshold
Sponsored by
NHS Fife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Arthroscopic Shoulder Surgery focused on measuring Arthroscopic shoulder surgery, Pain threshold

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Victoria Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrical pain threshold measrement patients

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2011
Last Updated
May 9, 2011
Sponsor
NHS Fife
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1. Study Identification

Unique Protocol Identification Number
NCT01351363
Brief Title
Prediction Of Post Operative Pain Following Arthroscopic Shoulder Surgery
Official Title
PREDICTION OF POST OPERATIVE PAIN FOLLOWING ARTHROSCOPIC SHOULDER SURGERY
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
NHS Fife

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroscopic Shoulder Surgery, Pain Threshold
Keywords
Arthroscopic shoulder surgery, Pain threshold

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical pain threshold measrement patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Electrical pain threshold measurement
Other Intervention Name(s)
Pain Matcher ® (Cefar Medical AB, Lund, Sweden)
Intervention Description
Assessment of preoperative pain threshold using electrical stimulation using a Painmatcher machine.
Intervention Type
Device
Intervention Name(s)
Measurement of electrical pain threshold
Other Intervention Name(s)
Pain Matcher ® (Cefar Medical AB, Lund, Sweden)
Intervention Description
Measurement of preoperative electrical pain threshold and self reporting of postoperative pain scores (for 4 days) on VAS.
Primary Outcome Measure Information:
Title
Post operative pain level
Description
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.
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Davis, MBChB
Organizational Affiliation
NHS Fife
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria Hospital
City
Kirkcaldy
State/Province
Fife
ZIP/Postal Code
KY2 5AH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24358863
Citation
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.
Results Reference
derived

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Prediction Of Post Operative Pain Following Arthroscopic Shoulder Surgery

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