Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000155998
Ethics application status
Approved
Date submitted
7/02/2011
Date registered
9/02/2011
Date last updated
14/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of local anaesthetic volume and concentration on the duration of peripheral nerve blockade in patients having shoulder surgery
Scientific title
The effect of local anaesthetic volume and concentration on the duration of peripheral nerve blockade in patients having shoulder surgery
Secondary ID [1] 253555 0
No secondary I.D.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Time to first pain after shoulder surgery 261115 0
Condition category
Condition code
Anaesthesiology 259262 259262 0 0
Anaesthetics
Musculoskeletal 259281 259281 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An experienced operator will place all interscalene catheters (ISCs). Patients will be premedicated with oral acetaminophen 1 g one hour before surgery. 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). General anesthesia will then be administered. Patients will then be randomized (using a computerised random number generator) to one of 5 bolus doses of ropivacaine: 1. 5 mL 0.75% 2. 10 mL 0.75% 3. 20 mL 0.375% 4. 20 mL 0.75% 5. 40 mL 0.375%

Due to unanticipated block failure in 2 of the 5 groups (5mL/0.75% and 10mL/0.75%), as of patient I.D 130 onwards, randomisation is now to 1 of 7 groups as follows:

1 = 5mL/0.75%
2 = 5mL/0.75%
3 = 10mL/0.75%
4 = 10mL/0.75%
5 = 20mL/0.375%
6 = 20mL/0.75%
7 = 40mL/0.375%

At the end of surgery, an ambulatory infusion of ropivacaine 0.2% at 2 mL/h with PRN “on demand” 5 mL boluses will be connected but the background infusion will remain clamped off. Patients will be instructed to turn it on (and to give the first bolus) as soon as they experience shoulder pain. The infusion will be continued for > 48 hours after surgery (Total duration = 2-5 days).
Intervention code [1] 257986 0
Treatment: Drugs
Comparator / control treatment
See intervention group.
Control group
Dose comparison

Outcomes
Primary outcome [1] 262076 0
Time to first pain as measured by patient documentation and research assistant interrogation on postoperative day 1
Timepoint [1] 262076 0
24 hours postoperatively, and again at 48 hours postoperatively for patients who have not experienced pain on postoperative day 1.
Secondary outcome [1] 273101 0
Postoperative pain as assessed by patient questionnaire using numerical rating pain score (0-10).
Timepoint [1] 273101 0
24 hours postoperatively
Secondary outcome [2] 273102 0
Tramadol consumption (number of tabs)
Timepoint [2] 273102 0
24 hours postoperatively
Secondary outcome [3] 273103 0
Hand numbness/weakness score as assessed by patient questionnaire using numerical rating score (0-10).
Timepoint [3] 273103 0
24 hours postoperatively
Secondary outcome [4] 273104 0
Dyspnoea as assessed by the presence (yes/no) of the subjective sensation of difficulty taking a breath.
Timepoint [4] 273104 0
24 hours postoperatively
Secondary outcome [5] 273105 0
Patient satisfactionas assessed by patient questionnaire using numerical rating score (0-10).
Timepoint [5] 273105 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 5 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 5 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
10/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 3169 0
New Zealand
State/province [1] 3169 0

Funding & Sponsors
Funding source category [1] 258440 0
Self funded/Unfunded
Name [1] 258440 0
Dr Michael Fredrickson
Country [1] 258440 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] 257586 0
None
Name [1] 257586 0
Address [1] 257586 0
Country [1] 257586 0
Secondary sponsor category [2] 284102 0
Commercial sector/Industry
Name [2] 284102 0
Kimberley Clark Corporation
Address [2] 284102 0
PO Box 2020, Neenah, USA
Country [2] 284102 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260428 0
Northern Y Regional Ethics Commitee
Ethics committee address [1] 260428 0
P O Box 1031
Hamilton
Waikato Mail Centre 3240
Ethics committee country [1] 260428 0
New Zealand
Date submitted for ethics approval [1] 260428 0
Approval date [1] 260428 0
28/09/2010
Ethics approval number [1] 260428 0
NTY/10/09/072

Summary
Brief summary
We intend to compare 5 different doses (by varying volume and concentration) of local anaesthetic administered for nerve block for pain relief after shoulder surgery. We will be primarily assessing the duration of the block as measured by the time to first pain. 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 32179 0
Address 32179 0
Country 32179 0
Phone 32179 0
Fax 32179 0
Email 32179 0
Contact person for public queries
Name 15426 0
Dr Michael Fredrickson
Address 15426 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 15426 0
New Zealand
Phone 15426 0
+64 9 522 1117
Fax 15426 0
+64 9 522 1127
Email 15426 0
[email protected]
Contact person for scientific queries
Name 6354 0
Dr Michael Fredrickson
Address 6354 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 6354 0
New Zealand
Phone 6354 0
+64 9 522 1117
Fax 6354 0
+64 9 522 1127
Email 6354 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.