Prediction Of Post Operative Pain Following Arthroscopic Shoulder Surgery

Pain Threshold Clinical Trial

Official title:

PREDICTION OF POST OPERATIVE PAIN FOLLOWING ARTHROSCOPIC SHOULDER SURGERY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351363
• Other study ID #: SHLDR1
• Status: Completed
• Phase: N/A
• First received: May 9, 2011
• Last updated: May 9, 2011
• Start date: March 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: NHS Fife
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Arthroscopic Shoulder Surgery
• Pain Threshold
• Pain, Postoperative

Intervention

Device:
• Electrical pain threshold measurement
Assessment of preoperative pain threshold using electrical stimulation using a Painmatcher machine.
• Measurement of electrical pain threshold
Measurement of preoperative electrical pain threshold and self reporting of postoperative pain scores (for 4 days) on VAS.

Locations

Country	Name	City	State
United Kingdom	Victoria Hospital	Kirkcaldy	Fife

Sponsors (1)

Lead Sponsor	Collaborator
NHS Fife

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No