RecruitingPhase 4ACTRN12617000191392

Does the use of muscle relaxants during anaesthesia for hip arthroscopies influence the pressure on the perineum?

Influence of deep muscle relaxation on the pudendal nerve by the perineal post of a traction table during hip arthroscopic surgery


Sponsor

Prof. Thomas Ledowski

Enrollment

40 participants

Start Date

May 1, 2017

Study Type

Interventional

Conditions

Summary

Many types of surgery, such as some types of hip replacement surgery, hip arthroscopies or the re-alignment of femoral fractures need to be performed on a traction table. In order to not pull the patient off the operating table when pulling on the leg, a padded perineal post is used. However, once traction is applied, the patient’s pudendal nerve region is pressurized by the post and the nerve can subsequently be damaged. This can result in significant nerve dysfunction which may be short-lived, but can also last for years after surgery. Sexual dysfunction after operations on a traction table is a long-known, but difficult to avoid problem (1-3). Mallet et al.(1) studied 168 patients after either operations on a traction table or a normal (non-traction) operating table. They found a 40.5% rate of erectile dysfunction (ED) in otherwise young, healthy males even years after operations on a traction table. Investigating potential influencing factors, the dose of the muscle relaxant administered during the anaesthetic was the only modifiable factor, with higher doses likely to prevent ED. The authors concluded that good relaxation leading to lower traction forces required and consequentially lower pressures on the pudendal nerve explained the superior outcome after deeper muscle relaxation (1). Though this theory seems logical, it has actually never been proven. Aim of this study is to determine the effect of deep muscle relaxation on the pressure on the perineum by the perineal post during operations on a traction table. Using an ultra-thin (approx.1 mm) pressure sensor foil embedded into the perineal post, we propose to measure the changes in pressures on the pudendal nerve after muscle relaxation. Fourty patients scheduled for elective hip arthroscopic surgery at Joondalup Health Campus and Glengarry Private Hospital will be included in this study. All patients will receive a standard general anaesthetic. After traction is applied on the operated leg, the resulting pressure on the perineum will be recorded. With the applied traction unchanged, the patient then receives a dose of the muscle relaxant rocuronium and the resulting change in pressure will be monitored. This concludes the study. The proposed project will close a significant gap of knowledge and, in a simple and risk-free approach, may lead to a change in anaesthesia practice. In addition, the joint width (hip) wil be measured before and after apralysis using portable xrays. If the joint width increases after the paralysis, the traction on the patients's leg will be reduced until the joint width is back to pre-paralysis status. At this stage the pressure on the pudendal nerve will be recorded again. References 1. Mallet R, et al. Urology. 2005;65(3):559-63. 2. Brumback RJ, et al. The Journal of bone and joint surgery American volume. 1992;74(10):1450-5. 3. Chan PT, et al.The Journal of trauma. 1999


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates whether using a stronger dose of muscle relaxant during general anaesthesia for hip arthroscopy surgery can reduce pressure on a sensitive nerve in the groin (the pudendal nerve) that can be damaged when the leg is pulled during surgery. Nerve damage from this procedure can cause sexual and bladder problems. The study measures pressure through a thin sensor placed around the surgical support post, before and after the muscle relaxant is given. You may be eligible if: - You are between 18 and 60 years old - You are classed as ASA 1 or 2 (generally healthy or with mild medical conditions) - You are scheduled for elective hip arthroscopic surgery at Joondalup Health Campus or Glengarry Private Hospital - You will have a general anaesthetic using propofol and opioid (relaxant anaesthesia) You may NOT be eligible if: - You are allergic to rocuronium or sugammadex (the muscle relaxant and reversal agent) - You have a neuromuscular disorder or severe peripheral nerve damage - You will have spinal or regional nerve block anaesthesia before the observation period - You are under 18 or over 60 years old - You cannot give informed consent Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Muscle relaxation after induction of anaesthesia in patients undergoing hip arthroscopic surgery on a traction table. Relaxation will be achieved by intravenous administration of rocuronium 0.6 mg/kg

Muscle relaxation after induction of anaesthesia in patients undergoing hip arthroscopic surgery on a traction table. Relaxation will be achieved by intravenous administration of rocuronium 0.6 mg/kg (by the attending anaesthetist) approx. 5 minutes after traction has been applied to the operated leg. The pressure of the perineal post of the traction table on the patients' perineum will be measured by means of a pressure sensor mat build into the post before and 90 s after the muscle relaxant is applied. In addition, the width of the hip joint will be measured via xray before and after paralysis. In case the width of the hip joint increases after paralysis, the traction on the patient's leg will be decreased until the width of the joint is as before paralysis. At this stage, another pressure measurement at the pudendal nerve will be performed.


Locations(2)

Joondalup Health Campus - Joondalup

WA, Australia

Glengarry Private Hospital - Duncraig

WA, Australia

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ACTRN12617000191392