Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000201077
Ethics application status
Approved
Date submitted
1/03/2010
Date registered
10/03/2010
Date last updated
11/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound guided interscalene catheter placement effectiveness: the optimum distance for catheter advancement in patients requiring continuous interscalene analgesia following elective shoulder surgery.
Scientific title
Ultrasound guided interscalene catheter placement effectiveness: the optimum distance for catheter advancement in patients requiring continuous interscalene analgesia following elective shoulder surgery
Secondary ID [1] 1472 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia following shoulder surgery 256855 0
Condition category
Condition code
Anaesthesiology 257002 257002 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single operator will place all interscalene catheters in the operating room. 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 administration of a superficial cervical plexus block. Superficial cervical plexus blocks will be performed by the infiltration of 5-10 mL 1% lidocaine with epinephrine (1/200,000) along the posterior border of the sternomastoid muscle midway between the cricoid cartilage and mastoid process. Using a random number generator, patients will be randomized to one of 3 groups: An insulated Tuohy needle) will be inserted at a point approximately 3 cm cephalad to the level of sixth cervical vertebra at the posterior border of sternomastoid muscle. The bevel of the needle will be orientated laterally throughout. A 10-5 MHz linear ultrasound probe will then be placed in the axial plane. The needle will be advanced superficially in a caudal and peripheral direction until tissue displacement is observed just lateral to the 2 most superficial elements of the brachial plexus. Saline 10 mL will be injected down the needle to observe for appropriate fluid spread adjacent to the brachial plexus trunks, and a non-stimulating catheter advanced either 5 or 2.5 cm past the needle tip. If ultrasound imaging proves difficult, a brief appropriate muscle twitch will be sought with a nerve stimulator set to 0.8 mA to confirm brachial plexus position. The skin will be prepared with tincture of benzoin, and then approximately 1 mL of medical cyanoacrylate will be applied to the catheter entry site. An epidural catheter-locking device will secure the catheter to the skin. General anesthesia will then be administered without prior motor or sensory testing. Following standard intravascular injection precautions, ropivacaine 0.75% 10m/lidocaine 1% 10 will be administered via the catheter. All 3 groups will receive their treatments just once only. Duration of treatments 48 hours
Intervention code [1] 256038 0
Treatment: Devices
Comparator / control treatment
As per intervention group. Ropivacaine injected via the catheter advanced 0.25 cm beyond needle tip.
Control group
Active

Outcomes
Primary outcome [1] 257901 0
Primary outcome endpoint to be assessed is catheter effectiveness as measured by the proportion of patients reporting pain in the recovery room during the first 2 hours post surgery as assessed by nursed assessed patient numerical rating pain scale.
Timepoint [1] 257901 0
During the first 2 postoperative hours.
Secondary outcome [1] 263358 0
Secondary outcome endpoint to be measured is postoperative pain (self report numerical rating pain scale) during the first 48 hours after surgery as assessed by a blinded research assistant
Timepoint [1] 263358 0
During the first 48 postoperative hours.

Eligibility
Key inclusion criteria
Patients requiring continuous interscalene analgesia following elective shoulder surgery under the care of the Principal Investigator.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include patient refusal for interscalene block, severe respiratory disease or ischaemic heart disease, known neuropathy involving the arm 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)
Subjects will be recruited from/by: 1. Surgeon in his rooms. 2. By selection from the operation list. 3. By Participant Information Sheet mailed approximately 2 weeks prior to surgery. 4. By phone call during the week prior to surgery. 5. With informed consent in consultation with the Principal Investigator (PI). Allocation of treatment by randomised number generator will be used to assign the patient to one of the 3 groups. Allocation is concealed in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number.
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
28/05/2010
Actual
28/05/2010
Date of last participant enrolment
Anticipated
Actual
8/02/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 2498 0
New Zealand
State/province [1] 2498 0
Auckland

Funding & Sponsors
Funding source category [1] 256551 0
Commercial sector/Industry
Name [1] 256551 0
I-Flow Corporation
Country [1] 256551 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] 255851 0
None
Name [1] 255851 0
Address [1] 255851 0
Country [1] 255851 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258592 0
Northern Y Regional Ethics Commitee
Ethics committee address [1] 258592 0
Ethics committee country [1] 258592 0
New Zealand
Date submitted for ethics approval [1] 258592 0
Approval date [1] 258592 0
02/03/2010
Ethics approval number [1] 258592 0
NTY/10/EXP/007

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30853 0
Dr Michael Fredrickson
Address 30853 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 30853 0
New Zealand
Phone 30853 0
+6495221117
Fax 30853 0
Email 30853 0
[email protected]
Contact person for public queries
Name 14100 0
Dr Michael Fredrickson
Address 14100 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 14100 0
New Zealand
Phone 14100 0
+64 9 522 1117
Fax 14100 0
+64 9 522 1127
Email 14100 0
[email protected]
Contact person for scientific queries
Name 5028 0
Dr Michael Fredrickson
Address 5028 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 5028 0
New Zealand
Phone 5028 0
+64 9 522 1117
Fax 5028 0
+64 9 522 1127
Email 5028 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
No additional documents have been identified.