Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000591358
Ethics application status
Approved
Date submitted
3/08/2008
Date registered
21/11/2008
Date last updated
21/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of two concentrations of local anaesthetic for pain relief after shoulder rotator cuff repair
Scientific title
A comparison of 0.2 and 0.4% Ropivacaine for Ambulatory Patient Controlled Interscalene Analgesia after Rotator Cuff Repair
Secondary ID [1] 259929 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain relief after shoulder rotator cuff repair 3490 0
Condition category
Condition code
Anaesthesiology 3645 3645 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.4% ropivacaine for continuous interscalene block after rotator cuff repair for 48 hours postoperatively as required by the patient.
Intervention code [1] 3213 0
Treatment: Drugs
Comparator / control treatment
0.2% ropivacaine for continuous interscalene block after rotator cuff repair for 48 hours postoperatively as required by the patient.
Control group
Active

Outcomes
Primary outcome [1] 4545 0
Reduced pain after rotator cuff repair, assessed by patient interrogation regarding analgesic consumption and pain scores using numerical rating pain score (NRPS).
Timepoint [1] 4545 0
1-2 days post operatively.
Analgesic requirements and pain scores (0-10) measured in the afternoon of Day 1 and Day 2 following surgery.
Secondary outcome [1] 8444 0
Arm numbness/weakness
Timepoint [1] 8444 0
First 48 postoperative hours

Eligibility
Key inclusion criteria
Patients requiring continuous interscalene analgesia following rotator cuff repair under the care of the two investigators.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient refusal/inability to consent, age no limits
2. Allergy amide local anaesthetic (LA) drugs
3. Existing neurological disorders/neuropathy of the operative extremity
4. Infection at site of needle puncture
5. Severe respiratory disease
6. Chronic opioid therapy
7. Intolerance of all non-steroidal anti-inflammatory drugs (NSAIDs).

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)
A dedicated research assistant (Margaret Watkin) will invite patients to be included in the study and will perform the post operative phone call on days 1,2 and 10. The principal investigator will place all interscalene catheters. The patients PACU nurse will be asked to record the patients pain score on arrival in the PACU. Patients will be asked simple questions on postoperative day 1 through 2. Margaret Watkin will also coordinate the 3 month questionnaire. Assignment of patient to 0.2% or 0.4% concentration of ropivacaine will be delivered in a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised random number generator will be used to assign the patient to one of the 2 groups.
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
15/08/2008
Actual
15/10/2008
Date of last participant enrolment
Anticipated
Actual
1/04/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1097 0
New Zealand
State/province [1] 1097 0
Auckland

Funding & Sponsors
Funding source category [1] 3667 0
Government body
Name [1] 3667 0
Accident Compensation Corporation (ACC)
Country [1] 3667 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michael Fredrickson
Address
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country
New Zealand
Secondary sponsor category [1] 3294 0
None
Name [1] 3294 0
Address [1] 3294 0
Country [1] 3294 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5719 0
Northern X Regional Ethics Committee
Ethics committee address [1] 5719 0
Private Bag 92 522
Wellesley Street
Auckland 1141
Ethics committee country [1] 5719 0
New Zealand
Date submitted for ethics approval [1] 5719 0
Approval date [1] 5719 0
15/04/2008
Ethics approval number [1] 5719 0
NTX/08/04/026

Summary
Brief summary
If the primary hypothesis is confirmed, this study will provide evidence supporting the use of a higher concentration of ropivacaine than that which is routinely used in Auckland. At present the community standard is ropivacaine 0.2% for this technique. This may result in future patients experiencing less postoperative pain after rotator cuff repair. Potential benefits might include a lower incidence of post rotator cuff repair chronic pain.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 28797 0
Dr Michael Fredrickson
Address 28797 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 28797 0
New Zealand
Phone 28797 0
+6495221117
Fax 28797 0
Email 28797 0
[email protected]
Contact person for public queries
Name 11954 0
Dr Dr Michael Fredrickson
Address 11954 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 11954 0
New Zealand
Phone 11954 0
+64 9 522 1117
Fax 11954 0
+64 9 522 1127
Email 11954 0
[email protected]
Contact person for scientific queries
Name 2882 0
Dr Dr Michael Fredrickson
Address 2882 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 2882 0
New Zealand
Phone 2882 0
+64 9 522 1117
Fax 2882 0
+64 9 522 1127
Email 2882 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
SourceTitleYear of PublicationDOI
EmbaseAnalgesic effectiveness of ropivacaine 0.2% vs 0.4% via an ultrasound-guided C5-6 root/superior trunk perineural ambulatory catheter.2009https://dx.doi.org/10.1093/bja/aep195
N.B. These documents automatically identified may not have been verified by the study sponsor.