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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 1097 0
New Zealand
State/province [1] 1097 0

Funding & Sponsors
Funding source category [1] 3667 0
Government body
Name [1] 3667 0
Accident Compensation Corporation (ACC)
Address [1] 3667 0
P O Box 242
Wellington 6140
Country [1] 3667 0
New Zealand
Primary sponsor type
Dr Michael Fredrickson
Anaesthesia Institute
P O Box 109 199
Auckland 1149
New Zealand
Secondary sponsor category [1] 3294 0
Name [1] 3294 0
Address [1] 3294 0
Country [1] 3294 0

Ethics approval
Ethics application status
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
Ethics approval number [1] 5719 0

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
Public notes

Principal investigator
Name 28797 0
Dr Michael Fredrickson
Address 28797 0
Anaesthesia Institute
P O Box 109 199
Auckland 1149
Country 28797 0
New Zealand
Phone 28797 0
Fax 28797 0
Email 28797 0
Contact person for public queries
Name 11954 0
Dr Dr Michael Fredrickson
Address 11954 0
Anaesthesia Institute
P O Box 109 199
Auckland 1149
Country 11954 0
New Zealand
Phone 11954 0
+64 9 522 1117
Fax 11954 0
+64 9 522 1127
Email 11954 0
Contact person for scientific queries
Name 2882 0
Dr Dr Michael Fredrickson
Address 2882 0
Anaesthesia Institute
P O Box 109 199
Auckland 1149
Country 2882 0
New Zealand
Phone 2882 0
+64 9 522 1117
Fax 2882 0
+64 9 522 1127
Email 2882 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary