Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000103561
Ethics application status
Approved
Date submitted
14/01/2015
Date registered
5/02/2015
Date last updated
5/02/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of neuromuscular blocking agents on traction forces during total hip replacement surgery
Scientific title
Patients undergoing hip replacement surgery: impact of neuromuscular blockade on the forces required for visualization of the femoral neck.
Secondary ID [1] 285972 0
none
Universal Trial Number (UTN)
U1111-1166-0962
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pulling force in Newton reqired to visualize the femoral neck during hip replacement surgery 293911 0
Condition category
Condition code
Anaesthesiology 294215 294215 0 0
Anaesthetics
Surgery 294384 294384 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients scheduled for elective hip replacement surgery under general anaesthesia will be included. At the start of surgery, at the time the surgeon request a pulling force (via traction table) on a patients leg to expose the femoral neck, the previously non-paralysed patient will receive rocuronium 0.6 mg/kg intravenously. Traction forces will be measured in Newton via an electronic strain gauge build into the traction system and connected to a laptop pc.
Intervention code [1] 290950 0
Treatment: Drugs
Comparator / control treatment
Traction forces required for visualization of the femoral neck before vs. after intravenous administration of rocuronium 0.6 mg/kg.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294002 0
Change of traction forces required to visualize the femoral neck before and after paralysis with rocuronium.
Assessment via a custom-made strain gauge inserted between the "shoe"-part (fixation of patient foot) and the "handle"-part (tractioning device applying force to leg). Strain gauge conected via 2 input cables to laptop PC showing and recording all changes in force (N) "online".
Timepoint [1] 294002 0
Start of surgery, at time of initial approach to the femoral neck.
Secondary outcome [1] 312336 0
Change of traction forces with onset of paralysis after rocuronium administration (from no to full paralysis)
Assessment via a custom-made strain gauge inserted between the "shoe"-part (fixation of patient foot) and the "handle"-part (tractioning device applying force to leg). Strain gauge conected via 2 input cables to laptop PC showing and recording all changes in force (N) "online".
Assessment of neuromuscular blockade via NMT module for ulnar nerve stimulation (GE Healthcare, Helsinki, Finland).
Timepoint [1] 312336 0
As timepoint 1: at the start of surgery at the time of femoral neck approach.

Eligibility
Key inclusion criteria
scheduled for hip replacement surgery under general anaesthesia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
neuromuscular disease, regional or spinal anaesthesia, paralysis at start of surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Identifying inclusion criteria, written informed consent prior to surgery. No treatment allocation as all subjects willl receive same treatment (control is the pre-treatment traction force).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
The study is planned as pilot project. No formal sample size calculation has been performed.


Analysis of data:
KS-test for normal distribution. Comparison of forces pre- vs post paralysis with either paired t-test or wilcoxon rank sum test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2014
Actual
31/10/2014
Date of last participant enrolment
Anticipated
30/10/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3332 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 9112 0
6000 - City Delivery Centre

Funding & Sponsors
Funding source category [1] 290559 0
Self funded/Unfunded
Name [1] 290559 0
Thomas Ledowski
Country [1] 290559 0
Australia
Primary sponsor type
Individual
Name
Thomas Ledowski
Address
University of Western Australia
35 Stirling HWY
Crawley
WA 6009
Country
Australia
Secondary sponsor category [1] 289251 0
None
Name [1] 289251 0
Address [1] 289251 0
Country [1] 289251 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292203 0
Royal Perth Hospital
Ethics committee address [1] 292203 0
Wellington Street
Perth WA 6000
Ethics committee country [1] 292203 0
Australia
Date submitted for ethics approval [1] 292203 0
Approval date [1] 292203 0
15/11/2012
Ethics approval number [1] 292203 0
2012-144

Summary
Brief summary
Orthopaedic surgeons frequently claim that the administration of muscle relaxants (NMBA) in patients under general anaesthesia facilitate surgery, especially when significant forces may be required (e.g. dislocation of hip joint, femoral realignment during operation of femoral fractures). However, despite the fact that NMBA are frequently used during general anaesthesia for orthopaedic surgery, no evidence for their benefit on operating conditions exists. Therefore, this trial aims to investigate the influence of NMBA on traction forces during hip replacement surgery.
20 Patients scheduled for hip replacement surgery under general anaesthesia will be included in this trial. Patients will receive a standard general anaesthetic. Patients for this form of hip replacement surgery are generally operated on a special operating table with the patients feet placed in shoe-like brackets. This allows the application of significant tension and torque to the patients operated leg in order to enable the surgical preparation of the hip joint for the prosthesis. With the help of a measurement instrument (Newton Meter installed within the traction mechanic of the operating table) we will measure the forces required to extend a patient's leg to facilitate surgery. Thereafter, an NMBA (rocuronium = most often used NMBA at RPH) will be slowly administered to finally achieve muscle paralysis. During the time of paralysis development, traction forces on the leg will be measured.
Aim is to investigate whether NMBA can significantly reduce the forces required during hip replacement surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54050 0
Prof Thomas Ledowski
Address 54050 0
School of Medicine and Pharmacology
University of Western Australia
35 Stirling Hwy
Crawley WA 6009
Country 54050 0
Australia
Phone 54050 0
+61 8 92240210
Fax 54050 0
Email 54050 0
thomas.ledowski@health.wa.gov.au
Contact person for public queries
Name 54051 0
Prof Thomas Ledowski
Address 54051 0
School of Medicine and Pharmacology
University of Western Australia
35 Stirling Hwy
Crawley WA 6009
Country 54051 0
Australia
Phone 54051 0
+61 8 92240210
Fax 54051 0
Email 54051 0
thomas.ledowski@health.wa.gov.au
Contact person for scientific queries
Name 54052 0
Prof Thomas Ledowski
Address 54052 0
School of Medicine and Pharmacology
University of Western Australia
35 Stirling Hwy
Crawley WA 6009
Country 54052 0
Australia
Phone 54052 0
+61 8 92240210
Fax 54052 0
Email 54052 0
thomas.ledowski@health.wa.gov.au

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
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