Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000195550
Ethics application status
Approved
Date submitted
20/05/2006
Date registered
24/05/2006
Date last updated
24/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of the efficacy of the addition of a ropivacaine infusion to the analgesia provided by pre-emptive ropivacaine and intra-operative parecoxib for peri-operative pain management in adults undergoing elective arthroscopic rotator cuff surgery: a randomised double blind placebo controlled trial.
Scientific title
A study of the efficacy of the addition of a ropivacaine infusion to the analgesia provided by pre-emptive ropivacaine and intra-operative parecoxib for reduction of peri-operative pain in adults undergoing elective arthroscopic rotator cuff surgery: a randomised double blind placebo controlled trial.
Universal Trial Number (UTN)
Trial acronym
'Pain-Buster' trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator cuff surgery 1171 0
Condition category
Condition code
Musculoskeletal 1255 1255 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In patients undergoing rotator cuff surgery, either subacromial decompression or rotator cuff surgery post operative pain in the first 24 hours was treated with a slow drip continuous infusion of either Ropivacaine 0.75%. All patients had access to intra venous morphine or pethidine via patient controlled analgesia (PCA), and oral analgesics for breakthrough pain. The maximum and average pain for the first 12 hours and second 12 hours were analysed
Intervention code [1] 1059 0
Rehabilitation
Comparator / control treatment
Placebo of normal saline at 5 mls per hour via a fine catheter inserted into the subacromial space arthroscopically at completion of the operation.
Control group
Placebo

Outcomes
Primary outcome [1] 1693 0
To determine whether the addition of a ropivacaine infusion delivered via a continuous slow soaker pump to the operative bed reduces post operative pain following rotator cuff surgery, either subacromial decompression or rotator cuff repair in the first and second 12 hours post rotator cuff surgery.
Timepoint [1] 1693 0
Self reported pain scores at rest on a scale of 0 - 10 at 15, 30, 60 mins, 2, 8, 12, 18 and 24 hours were recorded. Pain at rest and with movement were recorded at 18 hours.
Secondary outcome [1] 3035 0
To determine the effect of early pain free post operative mobilisation on the development of frozen shoulder (adhesive capsulitis).
Timepoint [1] 3035 0
After rotator cuff surgery post operatively at 2 months for subacromial decompression and 4 months for rotator cuff repair.
Secondary outcome [2] 3036 0
Shoulder range of movement with a goniometer was recorded and analysed for correlation with pain scores.
Timepoint [2] 3036 0
In the first and second 12 hours post operatively.

Eligibility
Key inclusion criteria
Requiring rotator cuff surgery either subacromial decompression or tendon repair.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous surgery to that shoulderFractures or tumoursIrreparable tendon tears.

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)
Opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated treatment assignment using random permuted blocks of variable size, stratifying for two types of operation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
158
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1369 0
Charities/Societies/Foundations
Name [1] 1369 0
Australian Orthopaedic Association (Vic) Research Trust
Country [1] 1369 0
Australia
Funding source category [2] 1370 0
Commercial sector/Industry
Name [2] 1370 0
Surgical Synergies
Country [2] 1370 0
Australia
Primary sponsor type
Individual
Name
Monash University, Jennifer Coghlan PhD Scholar, Supervisors, A/Prof. Rachelle Buchbinder and A/Prof. Andrew Forbes.
Address
Country
Australia
Secondary sponsor category [1] 1209 0
Individual
Name [1] 1209 0
Simon BELL
Address [1] 1209 0
Country [1] 1209 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2726 0
Mercy Private Hospital
Ethics committee address [1] 2726 0
Ethics committee country [1] 2726 0
Australia
Date submitted for ethics approval [1] 2726 0
Approval date [1] 2726 0
14/01/2004
Ethics approval number [1] 2726 0
RPO/45P
Ethics committee name [2] 2727 0
Linacre Private Hospital
Ethics committee address [2] 2727 0
Ethics committee country [2] 2727 0
Australia
Date submitted for ethics approval [2] 2727 0
Approval date [2] 2727 0
20/01/2004
Ethics approval number [2] 2727 0
2003/905MC

Summary
Brief summary
The study was to assess the efficacy in reducing pain of the addition of a slow soaker infusion of Ropivacaine (a local anaesthetic) compared with a placebo of normal saline via fine catheter placed inside the sholder joint at the end of the operation. The amount of additional narcotic agents and oral analgesics required by the patients was measured between the active and placebo groups. The hypothesis was that the local analgesic did not give better pain relief or reduce the amount of extra analgesics required.
In this randomised placebo controlled trial the surgeon, the patient, the ward nurses , physiotherapists and outcome assessor were all blinded to the treatment allocation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35934 0
Address 35934 0
Country 35934 0
Phone 35934 0
Fax 35934 0
Email 35934 0
Contact person for public queries
Name 10248 0
Jennifer Coghlan
Address 10248 0
Department of Clinical Epidemiology
Monash University
Cabrini Hospital
Suite 41
183 Wattletree Road
Malvern VIC 3144
Country 10248 0
Australia
Phone 10248 0
+61 3 95923775
Fax 10248 0
Email 10248 0
[email protected]
Contact person for scientific queries
Name 1176 0
Jennifer Coghlan and Associate Professor Rachelle Buchbinder
Address 1176 0
Department of Clinical Epidemiology
Monash University
Cabrini Hospital
Suite 41
183 Wattletree Road
Malvern VIC 3144
Country 1176 0
Australia
Phone 1176 0
+61 3 95923775
Fax 1176 0
Email 1176 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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