Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000114842
Ethics application status
Approved
Date submitted
24/01/2012
Date registered
24/01/2012
Date last updated
24/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of orifice configuration on the effectiveness of continuous peripheral nerve blockade
Scientific title
Effect of orifice configuration on the effectiveness of continuous peripheral nerve blockade in patients having shoulder surgery
Secondary ID [1] 279782 0
No secondary I.D.
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia after shoulder surgery 285660 0
Condition category
Condition code
Anaesthesiology 285840 285840 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An experienced operator will place all interscalene catheters (ISCs). Intravenous midazolam 2 mg, alfentanil 0.5 mg and cephazolin 1 g will be administered 5 min prior to interscalene catheter placement. Catheters will be placed following either the administration of a superficial cervical plexus block (SCPB) or after the induction of general anesthesia depending on patient preference. ISCs will be placed using a combination of ultrasound and nerve stimulation as previously described (Fredrickson et al. Anesthesiology 2010; 112:1374-1381, ANZCTR—12609000347268). Patients will then be randomised (using a computerised random number generator) to an single hole, triple hole or 6 hole perineural catheter. 15 mL ropivacaine 0.375% will be administered via the catheter. At the end of surgery under general anaesthesia, an ambulatory infusion of ropivacaine 0.2% at 2 mL/h with PRN “on demand” 5 mL boluses. The infusion will be continued for > 48 hours after surgery (Total duration = 2-5 days).
Intervention code [1] 284101 0
Treatment: Devices
Comparator / control treatment
See intervention group. The control group will be the triple hole group.
Control group
Active

Outcomes
Primary outcome [1] 286348 0
Proportion of patients of patients reporting pain the recovery room as assessed by patient interrogation by recovery room nurse
Timepoint [1] 286348 0
Within 1 hour after surgery
Secondary outcome [1] 295641 0
Time to first pain as measured by patient documentation and research assistant interrogation on postoperative day 1
Timepoint: 24 hours postoperatively, and again at 48 hours postoperatively for patients who have not experienced pain on postoperative day 1.
Timepoint [1] 295641 0
24 hours postoperatively, and again at 48 hours postoperatively for patients who have not experienced pain on postoperative day 1.
Secondary outcome [2] 295642 0
Postoperative pain as assessed by patient questionnaire using numerical rating pain score (0-10).
Timepoint: 24 hours postoperatively
Timepoint [2] 295642 0
24 hours postoperatively
Secondary outcome [3] 295643 0
Tramadol consumption (number of tabs) as assessed by patient interrogation by research assistant
Timepoint [3] 295643 0
24 hours postoperatively
Secondary outcome [4] 295644 0
Hand numbness/weakness score as assessed by patient questionnaire using numerical rating score (0-10).
Timepoint [4] 295644 0
24 hours postoperatively

Eligibility
Key inclusion criteria
Patients requiring anaesthesia for shoulder surgery under the care of the principal and co-investigators.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include patient refusal for upper limb block, severe respiratory disease, known neuropathy involving the limb undergoing surgery, and known allergy to amide local anaesthetic drugs.

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)
Initial invitation to participate in the study will occur one week prior to surgery, where patients will be contacted by a research assistant and invited to participate. Written informed consent will be obtained from all patients. Assignment of the patient to one of the 3 groups will be delivered in sealed opaque envelopes.
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 3 groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/01/2012
Actual
24/01/2012
Date of last participant enrolment
Anticipated
Actual
13/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 4073 0
New Zealand
State/province [1] 4073 0

Funding & Sponsors
Funding source category [1] 284560 0
Self funded/Unfunded
Name [1] 284560 0
Dr Michael Fredrickson
Country [1] 284560 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] 283482 0
None
Name [1] 283482 0
Address [1] 283482 0
Country [1] 283482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286543 0
Northern Y Regional Ethics Commitee
Ethics committee address [1] 286543 0
P O Box 1031
Hamilton
Waikato Mail Centre 3240
Ethics committee country [1] 286543 0
New Zealand
Date submitted for ethics approval [1] 286543 0
Approval date [1] 286543 0
19/10/2012
Ethics approval number [1] 286543 0
NTY/10/Exp007

Summary
Brief summary
We intend to compare 3 different orifice configurations for perineural catheters administered for nerve block for pain relief after shoulder surgery. We will be primarily assessing the frequency of pain in recovery. We will also assess the effectiveness of the pain relief, analgesic consumption, side effects and patient satisfaction.
Trial website
None
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 33669 0
Dr Michael Fredrickson
Address 33669 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 33669 0
New Zealand
Phone 33669 0
+649521 1117
Fax 33669 0
Email 33669 0
[email protected]
Contact person for public queries
Name 16916 0
Dr Dr Michael Fredrickson
Address 16916 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 16916 0
New Zealand
Phone 16916 0
+64 9 522 1117
Fax 16916 0
+64 9 522 1127
Email 16916 0
[email protected]
Contact person for scientific queries
Name 7844 0
Dr Dr Michael Fredrickson
Address 7844 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 7844 0
New Zealand
Phone 7844 0
+64 9 522 1117
Fax 7844 0
+64 9 522 1127
Email 7844 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
Dimensions AIRandomised Comparison of an End-Hole, Triple-Hole and Novel Six-Hole Catheter for Continuous Interscalene Analgesia2014https://doi.org/10.1177/0310057x1404200108
N.B. These documents automatically identified may not have been verified by the study sponsor.