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Trial registered on ANZCTR


Registration number
ACTRN12611000433909
Ethics application status
Approved
Date submitted
27/04/2011
Date registered
27/04/2011
Date last updated
27/04/2023
Date data sharing statement initially provided
27/04/2023
Date results information initially provided
27/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of ropivacaine concentration on duration for interscalene blocks given for arthroscopic shoulder surgery: a prospective randomised controlled trial
Scientific title
Effect of ropivacaine concentration on duration for interscalene blocks given for arthroscopic shoulder surgery: a prospective randomised controlled trial
Secondary ID [1] 260065 0
Nil
Universal Trial Number (UTN)
U1111-1120-9031
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder arthroscopic surgery analgesia 265733 0
Condition category
Condition code
Anaesthesiology 265871 265871 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing elective arthroscopic shoulder surgery will receive an ultrasound guided interscalene nerve block with 20mls of a randomly allocated ropivacaine concentration.

Arm 1
0.1% ropivacaine

Arm 2
0.2% ropivacaine

Arm 3
0.375% ropivacaine

Arm 4
0.75% ropivacaine
Intervention code [1] 264482 0
Treatment: Drugs
Comparator / control treatment
Active control - interscalene nerve block with 20mls of 0.75% ropivacaine
Control group
Dose comparison

Outcomes
Primary outcome [1] 266639 0
Duration before analgesic effect of block wears off as reported by the patient
Timepoint [1] 266639 0
Checked at day 1 and day 2 post-operatively.
Secondary outcome [1] 276124 0
Opioid usage (converted to oral oxycodone equivalent)
Timepoint [1] 276124 0
Within first 24 hours following surgery
Secondary outcome [2] 276125 0
Shoulder pain as assessed using numeric verbal rating score at rest and on movement
Timepoint [2] 276125 0
15 minutes, 60 minutes, and 24 hours following surgery
Secondary outcome [3] 276126 0
Nausea, vomiting and antiemetic usage
Timepoint [3] 276126 0
Within first 24 hours of surgery
Secondary outcome [4] 276127 0
Motor block assessed by hand grip dynamometer
Timepoint [4] 276127 0
pre-op, in post anaesthetic care unit and the next day
Secondary outcome [5] 276128 0
Respiratory function assessed by peak expiratory flow rate measured by a peak flow meter, and episodes of O2 saturation < 93% measured by a pulse oximeter
Timepoint [5] 276128 0
pre-op, in post anaesthetic care unit and the next day
Secondary outcome [6] 276129 0
Hoarse voice assessed clinically by anaesthetic nurse/doctor
Timepoint [6] 276129 0
pre-op, in post anaesthetic care unit and the next day
Secondary outcome [7] 276130 0
Horners syndrome assessed clinically by anaesthetic nurse/doctor
Timepoint [7] 276130 0
pre-op, in post anaesthetic care unit and the next day
Secondary outcome [8] 276131 0
Participant satisfaction with their analgesic care, scored with a verbal numeric scale 0-10.
Timepoint [8] 276131 0
before patient is discharged home

Eligibility
Key inclusion criteria
Elective arthroscopic shoulder surgery
Age 18-80 years
ASA 1-3
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal

Previous involvement in this study

Contraindication to interscalene block (patient refusal, coagulopathy, sepsis, local infection, severe respiratory disease, allergy to ropivacaine)

Upper limb neurological disease or deficits

Opioid tolerance (defined as use of >30mg oral morphine/day or equivalent – fentanyl patch 12mcg/hr, buprenorphine 20mcg/hr, oxycodone >20mg/day)

Contraindication to COX2 inhibitors/NSAIDs (renal impairment, NSAIDs/aspirin trigger asthma, active peptic ulcer disease, or allergy).

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)
Numbered syringes that were prepared with the randomly allocated ropivacaine concentration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using online computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A power analysis was performed using IBM SPSS SamplePower 3.0.1. with an oneway analysis of variance. We deemed that a 30% difference in block duration was clinically significant. Using Sharaf and Davis (2010) unpublished pilot study’s mean duration of block (14.86 hr) and SD (5.32), for a power of 80% to find a 30% change in block duration, a sample size of 29 in each group is required. Hence a sample size of 35 in each group was chosen to allow for patient withdrawals or block failure.

Time-to-event variables (block durations) were analysed using a Kaplan-Meier log-rank tests. Binary outcomes were analysed using Fischer’s Exact test. Normally distributed continuous variables were analysed using linear regression if measured on a single occasion (total opioid consumption) or Kruskall-Wallis tests if non-normally distributed despite transformation (Satisfaction). Grip strength was analysed using a Kruskall-Wallis-test at baseline and using pairwise van Elteren tests at each timepoint following intervention.

Reference:
Sharaf S, Davis N. Low concentration (0.2% ropivacaine) local anaesthetic interscalene brachial plexus block both facilitates early mobilisation and increases patient satisfaction following shoulder surgery: Flinders Medical Centre, Adelaide, Australia, 2010.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
24/01/2012
Date of last participant enrolment
Anticipated
Actual
22/12/2016
Date of last data collection
Anticipated
Actual
23/12/2016
Sample size
Target
140
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 24617 0
Repatriation Hospital - Daw Park
Recruitment postcode(s) [1] 3950 0
5041
Recruitment postcode(s) [2] 40228 0
5041 - Daw Park
Recruitment postcode(s) [3] 3951 0
5042
Recruitment postcode(s) [4] 3952 0
5168

Funding & Sponsors
Funding source category [1] 264957 0
Hospital
Name [1] 264957 0
Southern Adelaide Health Service
Country [1] 264957 0
Australia
Primary sponsor type
Individual
Name
Dr Jason Koerber
Address
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia
5042
Country
Australia
Secondary sponsor category [1] 264055 0
Individual
Name [1] 264055 0
Dr Nathan Davis
Address [1] 264055 0
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia
5042
Country [1] 264055 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266923 0
South Adelaide Health Service Research Ethics Committee
Ethics committee address [1] 266923 0
Research Ethics Office
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 266923 0
Australia
Date submitted for ethics approval [1] 266923 0
27/04/2011
Approval date [1] 266923 0
01/07/2011
Ethics approval number [1] 266923 0

Summary
Brief summary
Arthroscopic shoulder surgery may produce severe pain that is a challenge to control. Interscalene nerve blocks have been shown to be an excellent method of analgesia. It is not clear what concentration of local anaesthetic should be used for interscalene blocks to maximise pain relief and minimise side-effects. We aim to determine if lower compared to higher concentrations of ropivacaine (a local anaesthetic) can produce comparable pain relief duration with less side-effects.
Trial website
Trial related presentations / publications
The manuscript is presently undergoing journal submission.
Public notes

Contacts
Principal investigator
Name 32539 0
Dr Jason Koerber
Address 32539 0
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 32539 0
Australia
Phone 32539 0
+61 8 82045511
Fax 32539 0
Email 32539 0
jason.koerber@internode.on.net
Contact person for public queries
Name 15786 0
Dr Dr Jason Koerber
Address 15786 0
Anaesthetic Department
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia
5042
Country 15786 0
Australia
Phone 15786 0
+61 8 8204 5511
Fax 15786 0
+61 8 8204 5450
Email 15786 0
Jason.Koerber@health.sa.gov.au
Contact person for scientific queries
Name 6714 0
Dr Dr Jason Koerber
Address 6714 0
Anaesthetic Department
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia
5042
Country 6714 0
Australia
Phone 6714 0
+61 8 8204 5511
Fax 6714 0
+61 8 8204 5450
Email 6714 0
Jason.Koerber@health.sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No


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.