ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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]

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

Condition category

Condition code

Anaesthesiology

Anaesthetics

Surgery

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]

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]

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]

Start of surgery, at time of initial approach to the femoral neck.

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Royal Perth Hospital - Perth

Recruitment postcode(s) [1]

6000 - City Delivery Centre

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Thomas Ledowski

Address [1]

University of Western Australia
35 Stirling HWY
Crawley
WA 6009

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Perth Hospital

Ethics committee address [1]

Wellington Street
Perth WA 6000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/11/2012

Ethics approval number [1]

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

Prof Thomas Ledowski

Address

School of Medicine and Pharmacology
University of Western Australia
35 Stirling Hwy
Crawley WA 6009

Country

Australia

Phone

+61 8 92240210

Fax

thomas.ledowski@health.wa.gov.au

Contact person for public queries

Name

Thomas Ledowski

Address

School of Medicine and Pharmacology
University of Western Australia
35 Stirling Hwy
Crawley WA 6009

Country

Australia

Phone

+61 8 92240210

Fax

thomas.ledowski@health.wa.gov.au

Contact person for scientific queries

Name

Thomas Ledowski

Address

School of Medicine and Pharmacology
University of Western Australia
35 Stirling Hwy
Crawley WA 6009

Country

Australia

Phone

+61 8 92240210

Fax

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

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically