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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

pressure on the pudendal nerve

Anaesthesia for hip arthroscopic surgery

Condition category

Condition code

Surgery

Other surgery

Anaesthesiology

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]

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]

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]

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]

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]

Before and after paralysis at the begining of surgery.

Secondary outcome [1]

none

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

3/04/2017

Actual

1/05/2017

Date of last participant enrolment

Anticipated

29/12/2017

Actual

Date of last data collection

Anticipated

29/12/2017

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Joondalup Health Campus - Joondalup

Recruitment hospital [2]

Glengarry Private Hospital - Duncraig

Recruitment postcode(s) [1]

6027 - Joondalup

Recruitment postcode(s) [2]

6023 - Duncraig

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Perth Hospital

Address [1]

Level 2 RPH MRF Building
Rear 50 Murray Street
Perth WA 6000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of the Joondalup Health Campus

Ethics committee address [1]

Corner Grand Blvd and Shenton Ave
Joondalup WA 6919

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/09/2016

Approval date [1]

27/10/2016

Ethics approval number [1]

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

Prof Thomas Ledowski

Address

Royal Perth Hospital
Medical Research Foundation
Level 2 RPH MRF Building
Rear 50 Murray Street
Perth WA 6000

Country

Australia

Phone

+61892240210

Fax

thomas.ledowski@health.wa.gov.au

Contact person for public queries

Name

Thomas Ledowski

Address

Royal Perth Hospital
Medical Research Foundation
Level 2 RPH MRF Building
Rear 50 Murray Street
Perth WA 6000

Country

Australia

Phone

+61892240210

Fax

thomas.ledowski@health.wa.gov.au

Contact person for scientific queries

Name

Thomas Ledowski

Address

Royal Perth Hospital
Medical Research Foundation
Level 2 RPH MRF Building
Rear 50 Murray Street
Perth WA 6000

Country

Australia

Phone

+61892240210

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

Source	Title	Year of Publication	DOI
Embase	Deep neuromuscular paralysis during hip arthroscopic surgery: Influence on perineal tissue pressures and hip joint width.	2020	https://dx.doi.org/10.1093/jhps/hnaa049

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically