Arthroscopic Shoulder SurgeryNCT01351363
Prediction Of Post Operative Pain Following Arthroscopic Shoulder Surgery
A study testing Electrical pain threshold measurement and Measurement of electrical pain threshold in people with Arthroscopic Shoulder Surgery and Pain Threshold, run by NHS Fife at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthroscopic Shoulder Surgery, Pain Threshold
- What is being tested?
- Electrical pain threshold measurement and Measurement of electrical pain threshold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2009to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients aged 18 years or older able to give informed consent undergoing arthroscopic shoulder surgery at NHS Fife (ASD or rotator cuff repair)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREDICTION OF POST OPERATIVE PAIN FOLLOWING ARTHROSCOPIC SHOULDER SURGERY
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.
Read the 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.
- Conditions
- Arthroscopic Shoulder Surgery, Pain Threshold
- Being tested
- Electrical pain threshold measurement, Measurement of electrical pain threshold
- Keywords
- Arthroscopic shoulder surgery, Pain threshold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical pain threshold measurementDevice
Also called Pain Matcher ® (Cefar Medical AB, Lund, Sweden)
Assessment of preoperative pain threshold using electrical stimulation using a Painmatcher machine.
Measurement of electrical pain thresholdDevice
Also called Pain Matcher ® (Cefar Medical AB, Lund, Sweden)
Measurement of preoperative electrical pain threshold and self reporting of postoperative pain scores (for 4 days) on VAS.
| Study group | Role | What they receive |
|---|---|---|
| Electrical pain threshold measrement patients | Experimental | Not described Receives: Device: Electrical pain threshold measurement; Device: Measurement of electrical pain threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startMar 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroscopic Shoulder SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Fife
- Sponsor type
- Other government
- Investigators
- Anthony Davis, MBChB, Principal investigator, NHS Fife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351363
- Sponsor's protocol ID
- SHLDR1
- Status last verified
- May 2011
- First submitted
- 9 May 2011
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24358863
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICTION OF POST OPERATIVE PAIN FOLLOWING ARTHROSCOPIC SHOULDER SURGERY
- ClinicalTrials.gov ID
- NCT01351363
- Acronym / sponsor ID
- SHLDR1
- Conditions
- Arthroscopic Shoulder Surgery, Pain Threshold
- Keywords
- Arthroscopic shoulder surgery, Pain threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- NHS FifeOther government
- Study start
- Mar 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrical pain threshold measrement patients | Experimental | Device: Electrical pain threshold measurement, Device: Measurement of electrical pain threshold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients aged 18 years or older able to give informed consent undergoing arthroscopic shoulder surgery at NHS Fife (ASD or rotator cuff repair)
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical pain threshold measurementAlso: Pain Matcher ® (Cefar Medical AB, Lund, Sweden)Assessment of preoperative pain threshold using electrical stimulation using a Painmatcher machine. | Device | Electrical pain threshold measrement patients |
| Measurement of electrical pain thresholdAlso: Pain Matcher ® (Cefar Medical AB, Lund, Sweden)Measurement of preoperative electrical pain threshold and self reporting of postoperative pain scores (for 4 days) on VAS. | Device | Electrical pain threshold measrement patients |
Primary outcome
Post operative pain level
Time frame: 4 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
- Derived from this study: PubMed 24358863Davis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Davis, MBChB principal investigator
NHS Fife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical pain threshold measurement and Measurement of electrical pain threshold in people with Arthroscopic Shoulder Surgery and Pain Threshold, run by NHS Fife at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain level (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01351363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2011.