Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000150448
Ethics application status
Approved
Date submitted
27/12/2006
Date registered
1/03/2007
Date last updated
1/03/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Post-operative pain management following arthroscopic rotator cuff repair. A comparison of inter-scalene block with subacromial bursal infusion
Scientific title
A prospective randomised control trial comparing post-operative pain relief after shoulder surgery, using regional anaesthesia inter-scalene block, compared with direct shoulder joint anaesthesia using a breg pump following arthroscopic rotator cuff repair of the shoulder for those patients with rotator cuff arthropathy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator cuff tear / arthropathy 1645 0
Condition category
Condition code
Anaesthesiology 1755 1755 0 0
Other anaesthesiology
Musculoskeletal 1756 1756 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective Randomised Control Trial

Patients undergoing an arthroscopic rotator cuff repair by Simon McMahon with the anaesthetic given by John Hyndman at Mercy Hospital, Dunedin, New Zealand will be eligible for enrolment in the study

After patients have given there consent to being in the study they will be randomised into Group 1 or 2
Randomisation will occur through a random generated number table

Group 2 (CONTROL): Those who will receive a long-acting inter-scalene block + IV/oral analgesia

Bupivacaine 0.375% 20-30mls (depending patients weight)

After patients have given their consent to being in the study they will be randomised
Patients will be asked to record their level of pain by
1. using a visual analogue scale (VAS) on paper

VAS = visual scale 100mm’s in length with no pain at the left hand side and worst pain ever experienced at the right hand side. Patients will be asked subjectively to place a mark on the line where they feel there level of pain is at there pre-operative assessment, and then 4, 8, 12, 24, 48 hours post-operation.

Any analgesics consumed at these times will also be recorded
Intervention code [1] 1367 0
Treatment: Surgery
Comparator / control treatment
Group 1 (COMPARATOR): Those patients who will be receiving a short acting inter-scalene block and subacromial infusion (Breg) pump + IV/oral analgesia

Interscalene block dosage:
lignocaine 1.5% 20-30 mls (depending on patients weight)

Subacromial infusion pump:
50mls 0.25% Bupivicaine
Control group
Active

Outcomes
Primary outcome [1] 2449 0
Level of Pain following surgery
Timepoint [1] 2449 0
Pre-operation, 4, 8, 12, 24, and 48 hours post-operation
Primary outcome [2] 2450 0
Visual analogue scale
Timepoint [2] 2450 0
Pre-operation, 4, 8, 12, 24, and 48 hours post-operation
Secondary outcome [1] 4216 0
Other medications used
Timepoint [1] 4216 0
Pre-operation, 4, 8 ,12, 24 and 48 hours post-operation.

Eligibility
Key inclusion criteria
1. All patients with a rotator cuff tear / arthropathy at Mercy Hospital who will2. undergo arthroscopic rotator cuff repair by Simon McMahon 3. be anaesthetised by John Hyndman4. All patients who wish to participate in the study and give consent to being in the study.
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those patients not able to give consent. Those patients who are sensitive or allergic to the medications given. Those patients who do not wish to participate and/or who do not give consent to being in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 396 0
New Zealand
State/province [1] 396 0

Funding & Sponsors
Funding source category [1] 1905 0
Hospital
Name [1] 1905 0
Mercy Hospital
Country [1] 1905 0
New Zealand
Funding source category [2] 1906 0
Hospital
Name [2] 1906 0
Dunedin Public Hospital
Country [2] 1906 0
New Zealand
Funding source category [3] 1907 0
University
Name [3] 1907 0
University of Otago
Country [3] 1907 0
New Zealand
Primary sponsor type
Individual
Name
Nigel Hartnett
Address
Country
Secondary sponsor category [1] 1720 0
Individual
Name [1] 1720 0
Simon McMahon
Address [1] 1720 0
Country [1] 1720 0
Secondary sponsor category [2] 1721 0
Individual
Name [2] 1721 0
John Hyndman
Address [2] 1721 0
Country [2] 1721 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3551 0
Mercy Hospital
Ethics committee address [1] 3551 0
Ethics committee country [1] 3551 0
New Zealand
Date submitted for ethics approval [1] 3551 0
Approval date [1] 3551 0
07/08/2006
Ethics approval number [1] 3551 0
LRS/06/04/016
Ethics committee name [2] 3552 0
Dunedin Public Hospital
Ethics committee address [2] 3552 0
Ethics committee country [2] 3552 0
New Zealand
Date submitted for ethics approval [2] 3552 0
Approval date [2] 3552 0
07/08/2006
Ethics approval number [2] 3552 0
LRS/06/04/016
Ethics committee name [3] 3553 0
University of Otago
Ethics committee address [3] 3553 0
Ethics committee country [3] 3553 0
New Zealand
Date submitted for ethics approval [3] 3553 0
Approval date [3] 3553 0
07/08/2006
Ethics approval number [3] 3553 0
LRS/06/04/016

Summary
Brief summary
Rotator cuff surgery ranks in the top 3 procedures performed according to Accident Compensation Commission records. Arthroscopic rotator cuff surgery is becoming more common as surgeons skills and techniques become better.However pain relief following an arthroscopic rotator cuff repair can be problematic. A number of different techniques have been described to overcome this problem. The one conventionally used is an interscalene block whereby the nerves at the base of the neck receive a local anaesthetic injection. The patient is then given IV/oral analgesics once the block has worn off. The main issues are that 1. sometimes the block does not work (ie.. does not provide pain relief/control) and 2. sometimes the patients get concerned that the block fails to resolve (ie.. they are left with a short-term almost paralysis type picture) and makes movements and sensation of the affected arm difficult for the patient.There is no accepted consensus on which technique is best, however, recently devices have become available which infuse the anaesthetic directly into the shoulder joint. The results both locally and internationally although anecdotal (no scientific paper has compared the two techniques) are promising and may lead to better and more effective pain control as well as taking away the patients concern regarding there non-functioning arm.We will be undertaking the first project to compare the traditional technique against a direct local anaesthetic infusion pump. We feel that the potential health outcomes from this new technique for pain control, may change what is now considered standard treatment. It may even become practical for use in other areas of Arthroscopy such as the knee, ankle, elbow or wrist
Our hypothesis is that there is an advantage in terms of post op pain relief with the use of a Breg Pain Pump with a short acting brachial plexus block compared to a long acting brachial plexus block.
We will be doing this by using a visual analogue score for the patients to see whether there is any statistical significant difference between group 1 (those who will be receiving a short acting inter-scalene block and subacromial infusion pump) compared with group 2 (those who will receive a long-acting inter-scalene block)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27594 0
Address 27594 0
Country 27594 0
Phone 27594 0
Fax 27594 0
Email 27594 0
Contact person for public queries
Name 10556 0
Mr. Simon McMahon
Address 10556 0
Mercy Hospital
Private Bag 1919
Dunedin
Country 10556 0
New Zealand
Phone 10556 0
+64 3 4672315
Fax 10556 0
Email 10556 0
[email protected]
Contact person for scientific queries
Name 1484 0
Nigel Hartnett
Address 1484 0
Orthopaedic Registrar
Orthopaedic Department
Dunedin Public Hospital
Private Bag 1921
Dunedin
Country 1484 0
New Zealand
Phone 1484 0
+64 3 4740999
Fax 1484 0
Email 1484 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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