Prediction Of Post Operative Pain Following Arthroscopic Shoulder Surgery

This study has been completed.
Sponsor:
Information provided by:
NHS Fife
ClinicalTrials.gov Identifier:
NCT01351363
First received: May 9, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Arthroscopic Shoulder Surgery
Pain Threshold
Device: Electrical pain threshold measurement
Device: Measurement of electrical pain threshold

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: PREDICTION OF POST OPERATIVE PAIN FOLLOWING ARTHROSCOPIC SHOULDER SURGERY

Further study details as provided by NHS Fife:

Primary Outcome Measures:
  • Post operative pain level [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 43
Study Start Date: March 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electrical pain threshold measrement patients Device: Electrical pain threshold measurement
Assessment of preoperative pain threshold using electrical stimulation using a Painmatcher machine.
Other Name: Pain Matcher ® (Cefar Medical AB, Lund, Sweden)
Device: Measurement of electrical pain threshold
Measurement of preoperative electrical pain threshold and self reporting of postoperative pain scores (for 4 days) on VAS.
Other Name: Pain Matcher ® (Cefar Medical AB, Lund, Sweden)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351363

Locations
United Kingdom
Victoria Hospital
Kirkcaldy, Fife, United Kingdom, KY2 5AH
Sponsors and Collaborators
NHS Fife
Investigators
Principal Investigator: Anthony Davis, MBChB NHS Fife
  More Information

No publications provided

Responsible Party: Doctor Anthony Davis, NHS Fife
ClinicalTrials.gov Identifier: NCT01351363     History of Changes
Other Study ID Numbers: SHLDR1
Study First Received: May 9, 2011
Last Updated: May 9, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by NHS Fife:
Arthroscopic shoulder surgery
Pain threshold

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014