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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000740291
Ethics application status
Approved
Date submitted
19/08/2009
Date registered
26/08/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of two different flow rates of local anaesthetic for pain relief after shoulder rotator cuff repair
Scientific title
A comparison of Ropivacaine 2mL/hr and 5mL/hr for ambulatory patient controlled interscalene analgesia after rotator cuff repair
Secondary ID [1] 252408 0
Patient initiated mandatory intermittent boluses for ambulatory continuous interscalene analgesia: an effective strategy for optimising analgesia versus side effects
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 237059 0
Condition category
Condition code
Anaesthesiology 237378 237378 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.2% Ropivacaine at flow rate of 2mL/hr with regular 6 hourly 5 ml boluses for continuous interscalene block after rotator cuff repair for 48 hours postoperatively as required by the patient.
Intervention code [1] 236777 0
Treatment: Drugs
Comparator / control treatment
0.2% Ropivacaine at flow rate of 5mL/hr with as required only 5 ml boluses for continuous interscalene block after rotator cuff repair for 48 hours postoperatively as required by the patient.
Control group
Active

Outcomes
Primary outcome [1] 238182 0
Pain after rotator cuff repair, assessed by patient interrogation regarding analgesic consumption and pain scores using numerical rating pain score (NRPS).
Timepoint [1] 238182 0
Day 1 and 2 post operatively. Analgesic requirements and pain scores (0-10) measured in the afternoon of Day 1 and Day 2 following surgery.
Secondary outcome [1] 242484 0
Arm numbness/weakness
Timepoint [1] 242484 0
First 48 post operative hours.
1-2 days post operatively. Arm numbness and arm weakness (numerical rating scale) measured in the afternoon of Day 1 and Day 2 following surgery.

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
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Patient refusal/inability to consent.
2. Allergy amide local anaesthetic (LA).
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 will invite patients to be included in the study and will perform the post operative phone call on days 1 and 2. The investigators will place all interscalene catheters. The patients Post Anaesthesia Care Unit (PACU) nurse will be asked to record the patients pain score on arrival in the PACU. Patients will be asked simple questions on post operative day 1 through 2.
Assignment of patient to 2mL/hr or 5mL/hr flow rate of local anaesthetic 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
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1842 0
New Zealand
State/province [1] 1842 0

Funding & Sponsors
Funding source category [1] 237177 0
Commercial sector/Industry
Name [1] 237177 0
I-Flow Corporation
Address [1] 237177 0
20202 Windrow Drive Lake Forest CA 92630
Country [1] 237177 0
United States of America
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] 4670 0
None
Name [1] 4670 0
Address [1] 4670 0
Country [1] 4670 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239269 0
Northern X Regional Ethics Committee
Ethics committee address [1] 239269 0
Private Bag 92 522
Wellesley Street
Auckland 1141
Ethics committee country [1] 239269 0
New Zealand
Date submitted for ethics approval [1] 239269 0
Approval date [1] 239269 0
06/05/2009
Ethics approval number [1] 239269 0
NTX/08/04/026

Summary
Brief summary
This study aims to further refine the optimal infusion of ropivacaine to be used for continuous interscalene analgesia after shoulder surgery. A prevuous study compared ropivacaine 0.2% and 0.4% given at the same rate following rotator cuff repair. Analysis of the data has revealed little difference between the groups in any of the outcome parameters.

We propose to continue the study with similar methodology, but this time use ropivacaine 0.2% at two different flow rates, 2 ml/h and 5 ml/hr. We will be assessing effectiveness of the analgesia and side effects over the first 2 days postoperatively. essentially, the main hypothesis is that the higher flow rate will improve the pain relief after surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29767 0
Address 29767 0
Country 29767 0
Phone 29767 0
Fax 29767 0
Email 29767 0
Contact person for public queries
Name 13014 0
Dr Michael Fredrickson
Address 13014 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 13014 0
New Zealand
Phone 13014 0
+64 9 522 1117
Fax 13014 0
+64 9 522 1127
Email 13014 0
aiservice@xtra.co.nz
Contact person for scientific queries
Name 3942 0
Dr Michael Fredrickson
Address 3942 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 3942 0
New Zealand
Phone 3942 0
+64 9 522 1117
Fax 3942 0
+64 9 522 1127
Email 3942 0
aiservice@xtra.co.nz

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