RecruitingACTRN12615000103561

The impact of neuromuscular blocking agents on traction forces during total hip replacement surgery

Patients undergoing hip replacement surgery: impact of neuromuscular blockade on the forces required for visualization of the femoral neck.


Sponsor

Thomas Ledowski

Enrollment

20 participants

Start Date

Oct 31, 2014

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating whether muscle relaxant drugs given during general anaesthesia can reduce the amount of physical force needed during hip replacement surgery. Orthopaedic surgeons often use these drugs hoping they will make surgery easier, but this has never been properly measured. This study will use a special instrument on the operating table to record the forces needed at different stages of the operation. You may be eligible if: - You are 18 years of age or older - You are scheduled for hip replacement surgery under general anaesthesia You may NOT be eligible if: - You have a neuromuscular disease - You are having regional or spinal anaesthesia instead of general anaesthesia - You will already be paralysed (on muscle relaxants) at the start of the surgery Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 p

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.


Locations(1)

Royal Perth Hospital - Perth

WA, Australia

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ACTRN12615000103561