Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000637640
Ethics application status
Approved
Date submitted
6/06/2014
Date registered
17/06/2014
Date last updated
17/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of deep neuromuscular paralysis on the force required during dissection of the latissimus dorsi muscle for reconstructive breast surgery: a randomized blinded trial.
Scientific title
Effect of deep muscle relaxation with rocuronium versus administration of saline on the force required during dissection of the latissimus dorsi muscle for reconstructive breast surgery: a randomized blinded trial
Secondary ID [1] 284755 0
none
Universal Trial Number (UTN)
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
force required to lift a latissimus dorsi muscle flap during dissection of the muscle 292122 0
anaesthesia during breast reconstructive surgery 292123 0
Condition category
Condition code
Anaesthesiology 292456 292456 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous administration of a single dose of the muscle relaxant rocuronium (0.6 mg/kg) or 5 ml normal saline during latissimus dorsi flap dissection and measurement of force (N) required to lift the muscle a specific distance off its bed. The order of drug administration (rocuronium or saline) follows a randomization protocol, but requires no washout phase.
Intervention code [1] 289546 0
Treatment: Drugs
Comparator / control treatment
Normal saline is administered as control - intervention and control treatment will be administered sequentially (random order) to all participating subjects.
Control group
Placebo

Outcomes
Primary outcome [1] 292319 0
Force (N) required to lift the latissimus dorsi flap vertically off its surface during flap dissection. The force is measured using a commercially available sterile strain gauge mounted on a horizontal metal rod which allows positioning over the patient.
Timepoint [1] 292319 0
Specified by surgeon: time at which the muscle flap has been suficiently dissected to sling a sterile cotton tape round its circumference in order to lift the muscle slightly in vertical direction.
Secondary outcome [1] 308712 0
nil
Timepoint [1] 308712 0
nil

Eligibility
Key inclusion criteria
Female patients scheduled for elective breast reconstructive surgery with a latissimus dorsi flap.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
incapacity to or declining to consent, allergy to rocuronium, neuromuscular disorder or stroke with ongoing paralysis, ongoing treatment with muscle relaxing substances.

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)
Consent of participant prior to surgery.
Both treatment with rocuronium as well as the control (saline) treatment will be administered sequentially to all participants within a 5 minute time interval during surgery. The sequence of administration is subject to randomization and blinding.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomization sequence is generated via randomly permuted blocks. The allocation to "rocuronium first" or "saline first" is placed in a sealed envelope and each envelope his handed to the attending anaesthetist in theatre who will administer treatment and placebo in the allocated order with the researcher as well as the surgeon to remain blinded to this allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Treatment (rocuronium) and control (saline) will be administered in a random order (as allocated per randomization protocol) by the attending anaesthetist. The researcher and surgeon assessing the outcomes will be blinded by being positioned on the surgical side of the horizontally positioned surgical drape (separating the patients head zone from the surgical field).
Phase
Not Applicable
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
A sample size calculation was not performed as no related data is available. Hence the study is a pilot study by design.
Analysis of primary outcome parameter via t-test for related samples. Data will be displayed as mean (SD) or median (25%/75% percentile) as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2013
Actual
25/06/2013
Date of last participant enrolment
Anticipated
20/05/2014
Actual
20/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2609 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 8282 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 289370 0
Self funded/Unfunded
Name [1] 289370 0
Thomas ledowski
Country [1] 289370 0
Australia
Primary sponsor type
Individual
Name
Thomas ledowski
Address
Dept of Anaesthesia
Royal Perth Hospital
197 Wellington Street
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 288055 0
None
Name [1] 288055 0
Address [1] 288055 0
Country [1] 288055 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291136 0
Ethics Committee of the Royal Perth Hospital
Ethics committee address [1] 291136 0
Wellington Street
Perth WA 6000
Ethics committee country [1] 291136 0
Australia
Date submitted for ethics approval [1] 291136 0
Approval date [1] 291136 0
13/06/2012
Ethics approval number [1] 291136 0
12-060

Summary
Brief summary
The effect of muscle relaxation on latissimus dorsi ease of flap dissection are unknown though the technique has frequently ben recommended. The purpose of the trial is to measure the facilitation of flap dissection by means of assessing the force (N) required to lift the flap a few centimetres off its surface, thus mimicking surgical handling of the flap. The measurement is done with a sterile scale. 3 measurements will be done: 1. baseline, 2. after either rocuronium or saline administration intravenously, and 3. after administration of the drug (rocuronium or saline) not yet given at 2..
The measurement will be done by a researcher blinded to the administration sequence of the drugs.
Trial website
none
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 49046 0
Prof Thomas ledowski
Address 49046 0
Dept. of Anaesthesia
Royal Perth Hospital
197 Wellington Street
Perth WA 6000
Country 49046 0
Australia
Phone 49046 0
+61 8 9224 2244
Fax 49046 0
Email 49046 0
[email protected]
Contact person for public queries
Name 49047 0
Prof Thomas ledowski
Address 49047 0
Dept. of Anaesthesia
Royal Perth Hospital
197 Wellington Street
Perth WA 6000
Country 49047 0
Australia
Phone 49047 0
+61 8 9224 2244
Fax 49047 0
Email 49047 0
[email protected]
Contact person for scientific queries
Name 49048 0
Prof Thomas ledowski
Address 49048 0
Dept. of Anaesthesia
Royal Perth Hospital
197 Wellington Street
Perth WA 6000
Country 49048 0
Australia
Phone 49048 0
+61 8 9224 2244
Fax 49048 0
Email 49048 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
EmbaseThe effect of deep muscle relaxation on the force required during Latissimus Dorsi dissection for breast reconstructive surgery: Results of a prospective, double-blinded observational pilot study.2017https://dx.doi.org/10.1186/s12871-017-0315-5
N.B. These documents automatically identified may not have been verified by the study sponsor.