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Trial registered on ANZCTR


Registration number
ACTRN12617000191392
Ethics application status
Approved
Date submitted
2/02/2017
Date registered
6/02/2017
Date last updated
16/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the use of muscle relaxants during anaesthesia for hip arthroscopies influence the pressure on the perineum?
Scientific title
Influence of deep muscle relaxation on the pudendal nerve by the perineal post of a traction table during hip arthroscopic surgery
Secondary ID [1] 291056 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pressure on the pudendal nerve 301852 0
Anaesthesia for hip arthroscopic surgery 301861 0
Condition category
Condition code
Surgery 301532 301532 0 0
Other surgery
Anaesthesiology 301541 301541 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297045 0
Treatment: Drugs
Comparator / control treatment
no control group; patients act as own control (before and after administration of the muscle relaxant)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300936 0
Pressures on the participants' perineum by the perineal post of a traction table by means of a pressure sensor mat built into the perineal post of the traction table.
Timepoint [1] 300936 0
intra-operatively; directly before and 90 seconds after intravenous administration of rocuronium 0.6 mg/kg, as well as after reducing traction on the leg (in order to reduce hip joint width to pre-paralysis status).
Primary outcome [2] 303673 0
Width of the hip joint before and after neuromuscular paralysis in patients undergoing hip arthroscopic surgery on a traction table. The width of the joibt is measured via xrays taken during and after the traction.
Timepoint [2] 303673 0
Before and after paralysis at the begining of surgery.
Secondary outcome [1] 331243 0
none
Timepoint [1] 331243 0
none

Eligibility
Key inclusion criteria
40 patients (male and female), ASA 1-2, aged 18-60 years scheduled for elective hip arthroscopic surgery deemed appropriate (by attending anaesthetist) under relaxant general anaesthesia with propofol/opioid.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
allergy to rocuronium or sugammadex, neuromuscular disorder, severe peripheral neuropathy or anatomy excluding neuromuscular monitoring at the ulnar nerve, neuraxial anaesthesia or a femoral/sciatic nerve block prior to observation interval, age < 18 > 60 years, incapacity to consent.

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)
none
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
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All data will be checked for normal distribution (Komogorov-Smirnov Test) and will be displayed as either mean (SD) or median (percentiles). Data comparing numerical values (i.e. pre- and post- paralysis pressures) will be compared using either students t-test or a non-parametric alternative, as appropriate. Relationships between categorical parameters may be explored using the chi-square or Fishers exact tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7423 0
Joondalup Health Campus - Joondalup
Recruitment hospital [2] 7424 0
Glengarry Private Hospital - Duncraig
Recruitment postcode(s) [1] 15228 0
6027 - Joondalup
Recruitment postcode(s) [2] 15229 0
6023 - Duncraig

Funding & Sponsors
Funding source category [1] 295496 0
Hospital
Name [1] 295496 0
Royal Perth Hospital
Address [1] 295496 0
Level 2 RPH MRF Building
Rear 50 Murray Street
Perth WA 6000
Country [1] 295496 0
Australia
Primary sponsor type
Individual
Name
Prof. Thomas Ledowski
Address
Royal Perth Hospital
Medical REsearch Foundation
Level 2 RPH MRF Building
Rear 50 Murray Street
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 294315 0
None
Name [1] 294315 0
Address [1] 294315 0
Country [1] 294315 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296826 0
Ethics Committee of the Joondalup Health Campus
Ethics committee address [1] 296826 0
Corner Grand Blvd and Shenton Ave
Joondalup WA 6919
Ethics committee country [1] 296826 0
Australia
Date submitted for ethics approval [1] 296826 0
01/09/2016
Approval date [1] 296826 0
27/10/2016
Ethics approval number [1] 296826 0
1628

Summary
Brief 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
Trial website
none
Trial related presentations / publications
none yet
Public notes

Contacts
Principal investigator
Name 72142 0
Prof Thomas Ledowski
Address 72142 0
Royal Perth Hospital
Medical Research Foundation
Level 2 RPH MRF Building
Rear 50 Murray Street
Perth WA 6000
Country 72142 0
Australia
Phone 72142 0
+61892240210
Fax 72142 0
Email 72142 0
thomas.ledowski@health.wa.gov.au
Contact person for public queries
Name 72143 0
Prof Thomas Ledowski
Address 72143 0
Royal Perth Hospital
Medical Research Foundation
Level 2 RPH MRF Building
Rear 50 Murray Street
Perth WA 6000
Country 72143 0
Australia
Phone 72143 0
+61892240210
Fax 72143 0
Email 72143 0
thomas.ledowski@health.wa.gov.au
Contact person for scientific queries
Name 72144 0
Prof Thomas Ledowski
Address 72144 0
Royal Perth Hospital
Medical Research Foundation
Level 2 RPH MRF Building
Rear 50 Murray Street
Perth WA 6000
Country 72144 0
Australia
Phone 72144 0
+61892240210
Fax 72144 0
Email 72144 0
thomas.ledowski@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results