Trial Review

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
ACTRN12609000770268
Ethics application status
Approved
Date submitted
25/08/2009
Date registered
4/09/2009
Date last updated
31/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of continuous and one-off interscalene block for pain relief following minor shoulder surgery - for fractured clavicle.
Scientific title
A comparison of continuous and one -off interscalene block for pain relief following minor shoulder surgery - for fractured clavicle
Secondary ID [1] 283494 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients requiring postoperative analgesia following minor shoulder surgery (open reduction and internal fixation (ORIF) for fractured clavicle) 237058 0
Analgesia following minor shoulder surgery 243541 0
Condition category
Condition code
Anaesthesiology 237377 237377 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interscalene block
A single operator Dr Michael Fredrickson (MF) will place all interscalene catheters (ISCs) in the operating room. Patients will be premedicated with oral acetaminophen 1g, diclofenac SR 75mg and omeprazole 20mg one hour before surgery. Intravenous midazolam 2mg, alfentanil 0.5mg and cephazolin 1g 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 anaesthesia depending on patient preference. ISCs will be placed using a combination of ultrasound and nerve stimulation.

General anaesthesia will then be administered and ropivacaine 0.5% 0.5mL/kg to a maximum of 30 mL will be administered through the ISC.

Patients with a continuous interscalene block (CISB) will then receive an ambulatory infusion of ropivacaine 0.2% at the end of surgery.
Intervention code [1] 236776 0
Treatment: Devices
Comparator / control treatment
Patients receiving the one-off interscalene block would receive identical treatment, except no ambulatory infusion of ropivacaine would be administered at the end of surgery.
Control group
Active

Outcomes
Primary outcome [1] 238181 0
Postoperative pain as assessed by patient interrogation regarding oral analgesic consumption and pain scores using numerical rating pain score (NRPS).
Timepoint [1] 238181 0
1-2 days post operatively. Numerical rating pain score (NRPS) and Oral analgesic consumption measured in the afternoon of Day 1 and Day 2 following surgery.
Secondary outcome [1] 242483 0
Arm numbness/weakness measured by patient numerical rating scale (0-10) on post operative day 2 questionnaire.
Timepoint [1] 242483 0
First 48 hours postoperatively.

Eligibility
Key inclusion criteria
Patients undergoing elective minor shoulder surgery (open fixation for fractured clavicle) under the anaesthetic care of the principal investigator
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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. Patients intolerant 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)
An invitation to participate in the study will be posted to patients identified from the operating list. One preoperative phone call will be made by the research assistant to assess patient's suitability for the study. At this stage participation in this study would be discussed with the patient. Post operatively, patients will be questioned by phone for some simple data for the first 2 days following surgery.
Patients will be assigned to one of the two groups by random number generator, and assignments 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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
10/06/2009
Actual
11/06/2009
Date of last participant enrolment
Anticipated
Actual
9/12/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1841 0
New Zealand
State/province [1] 1841 0
Auckland

Funding & Sponsors
Funding source category [1] 237176 0
Self funded/Unfunded
Name [1] 237176 0
Dr Michael Fredrickson
Country [1] 237176 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] 4669 0
None
Name [1] 4669 0
Address [1] 4669 0
Country [1] 4669 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239267 0
Northern X Regional Ethics Committee
Ethics committee address [1] 239267 0
Private Bag 92 522
Wellesley Street
Auckland 1141
Ethics committee country [1] 239267 0
New Zealand
Date submitted for ethics approval [1] 239267 0
Approval date [1] 239267 0
10/06/2009
Ethics approval number [1] 239267 0
NTX/08/04/027

Summary
Brief summary
Continuous interscalene block (CISB) has been shown to provide better analgesia and patient satisfaction than opioids for rotator cuff surgery. Although CISB has been shown to provide better analgesia and patient satisfaction than opioids for rotator cuff repair, it is unknown whether these benefits apply to less painful procedures such as open reduction internal fixation (ORIF) clavicle. For this procedure randomized trials comparing CISB with traditional opioid analgesia have not been conducted.
The purpose of the current study is to determine whether CISB provides better analgesia and patient satisfaction than traditional single shot interscalene block (the community standard) following minor shoulder procedures (ORIF clavicle).
If the primary hypothesis is confirmed, this study will provide evidence supporting the use of continuous interscalene block for this surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29766 0
Dr Michael Fredrickson
Address 29766 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 29766 0
New Zealand
Phone 29766 0
+64 9 522 1117
Fax 29766 0
Email 29766 0
[email protected]
Contact person for public queries
Name 13013 0
Dr Dr Michael Fredrickson
Address 13013 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 13013 0
New Zealand
Phone 13013 0
+64 9 522 1117
Fax 13013 0
+64 9 522 1127
Email 13013 0
[email protected]
Contact person for scientific queries
Name 3941 0
Dr Dr Michael Fredrickson
Address 3941 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 3941 0
New Zealand
Phone 3941 0
+64 9 522 1117
Fax 3941 0
+64 9 522 1127
Email 3941 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.