ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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

ACTRN12619001140145

Ethics application status

Approved

Date submitted

2/08/2019

Date registered

15/08/2019

Date last updated

21/04/2021

Date data sharing statement initially provided

15/08/2019

Date results provided

21/04/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Patient-controlled transcutaneous electrical nerve stimulation for postoperative pain after abdominal surgery: a randomized pilot trial in an enhanced recovery after surgery hospital

Scientific title

Patient-controlled transcutaneous electrical nerve stimulation for postoperative pain after abdominal surgery: a randomized pilot trial in an enhanced recovery after surgery hospital

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1232-8888

Trial acronym

Linked study record

Health condition

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

Postoperative pain

Condition category

Condition code

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients will be allocated into 2 groups, both receiving the intervention at different intensities. Group 1 will have TENS applied and titrated to a stimulation intensity that is the maximal tolerable by the patient without being painful or inducing muscle contraction. Stimulation intensity set by each individual patient at the start of each session whereby patients will titrate it up. Once patients are satisfied with intensity, patients will be instructed not to change it for the rest of the session. It is anticipated final intensity will be approximately 30mA based on previous studies but this will vary depending on what the patient deems non-painful. There is no minimum/maximum intensity provided.

After the patient is taught how to administer the treatment by a study investigator, the patient will self-administer the treatment postoperatively. Patients will receive a TENS unit providing an asymmetric square biphasic wave form at a frequency of 80 pulses/s and a pulse width of 250 µs. TENS will be applied starting 1 hour post-surgery once patients are awake and alert, with each session applied for a duration of 30 minutes for the first 48hours postoperatively. Patients will be instructed to apply the TENS when they feel pain for pre-set 30-minute durations. Patients can terminate the session early if they experience discomfort or want to; we will ask patients to record events like this. The intervention will occur on the hospital recovery ward. Patients will be given a written form to track the intensity, timing and duration of each application. The TENS machine will be modified so only intensity can be changed to prevent tampering. Patients and the TENS unit will be checked on twice daily to monitor adherence.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Group 2 will have TENS applied and titrated to a stimulation intensity that is at the minimal sensory threshold where patients feel a faint tingling sensation from TENS application.
The use of a control group using a sham (inactive) TENS unit was decided against as previous attempts to blind TENS have been unable to produce reliable patient blinding in sham groups - we will attempt to investigate if a dose-dependent relationship can be shown.

Stimulation intensity set by each individual patient at the start of each session whereby patients will titrate it up. Once patients are satisfied with intensity (just above sensory threshold for Group 2), patients will be instructed not to change it for the rest of the session. It is anticipated final intensity will be approximately 5mA based on previous studies but this will vary depending on what the patient deems non-painful. There is no minimum/maximum intensity provided.

After the patient is taught how to administer the treatment by a study investigator, the patient will self-administer the treatment postoperatively. Patients will receive a TENS unit providing an asymmetric square biphasic wave form at a frequency of 80 pulses/s and a pulse width of 250 µs. TENS will be applied starting 1 hour post-surgery once patients are awake and alert, with each session applied for a duration of 30 minutes for the first 48hours postoperatively. Patients will be instructed to apply the TENS when they feel pain for pre-set 30-minute durations. Patients can terminate the session early if they experience discomfort or want to; we will ask patients to record events like this. The intervention will occur on the hospital recovery ward. Patients will be given a written form to track the intensity, timing and duration of each application. The TENS machine will be modified so only intensity can be changed to prevent tampering. Patients and the TENS unit will be checked on twice daily to monitor adherence.

Control group

Dose comparison

Outcomes

Primary outcome [1]

Tolerability of patient-controlled TENS use measured by incidence of side effects: skin irritation - skin irritation will be patient reported. A case of skin irritation will be defined as skin discomfort requiring the patient to terminate their 30-min TENS treatment session prematurely.

Timepoint [1]

Measured on discharge/48-hours postoperatively

Primary outcome [2]

Adequacy of patient blinding to their group allocation measured by a post-study questionnaire. This questionnaire is a yes/no questionnaire to determine what the group allocation the patient thought they were in and will be compared to their actual allocation.

Timepoint [2]

48 hours/On discharge

Secondary outcome [1]

Postoperative opioid use

Timepoint [1]

On postoperative day 0, postoperative day 1 (morning and evening), postoperative day 2 (morning and evening). This will be assessed from the medical records.

Secondary outcome [2]

Pain scores measured by numerical rating 0-10 scale (NRS)

Timepoint [2]

On postoperative day 0, postoperative day 1 (morning and evening), postoperative day 2 (morning and evening). This will be verbally assessed.

Secondary outcome [3]

Time to first stool

Timepoint [3]

Postoperatively - depending on surgical recovery. This will be assessed by asking the patient to report the approximate hour of first stool each time they are assessed for other outcomes.

Secondary outcome [4]

Time to tolerance of an oral diet

Timepoint [4]

Postoperatively - timepoint depending on surgical recovery. Will be defined as first intake of solid fool tolerated without nausea or vomiting. This will be assessed by asking the patient to report the approximate hour of first stool each time they are assessed for other outcomes.

Secondary outcome [5]

Surgical complications such as postoperative nausea and vomiting, reoperation, wound infection.

Timepoint [5]

Will be recorded as incidence postoperatively and based on medical notes. Complications will be classified via Clavien-Dindo scoring

Eligibility

Key inclusion criteria

- Patients undergoing open or laparoscopic (with an extraction site via a mini-laparotomy) abdominal surgery at Auckland District Health Board
- Able to understand risks and benefits of participating in the study
- Ability to provide informed consent

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Prior TENS use preventing adequate study group blinding
- Current pregnancy
- Epilepsy or prior history of seizures
- History of cardiac disease
- Implantable medical device such as pacemaker or implantable defibrillator
- ASA Grade IV or greater
- Inability to participate in post-operative assessments due to dementia, cognitive impairment, language difficulties, delirium
- Inability to operate TENS device by themselves

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation sequence will be concealed from the study team and kept in opaque numbered envelops in a secure central location. Assignment will be completed on the day of surgery.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer-randomization will be used to generate a number list.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

As this is a pilot trial not powered to show differences in endpoints, a qualitative analysis of primary outcomes will be completed. Statistical analysis will not be conducted on secondary outcomes.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

27/09/2019

Actual

15/10/2019

Date of last participant enrolment

Anticipated

27/04/2020

Actual

14/01/2020

Date of last data collection

Anticipated

18/05/2020

Actual

15/01/2020

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health and Research Council New Zealand

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Auckland

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

10/05/2019

Approval date [1]

11/06/2019

Ethics approval number [1]

19/CEN/80

Summary

Brief summary

The main aim of this study is to perform a pilot trial to determine if patient-controlled TENS applied in the immediate postoperative period is feasible and tolerable for patients undergoing major abdominal surgery within an ERAS protocol for the reduction of opioid use, pain, and the improvement of surgical recovery outcomes. Our hypothesis is that TENS is a patient-tolerable intervention with little to no side effects. We predict TENS will be easy and safe for patients to use. Although this study will not be powered for testing efficacy of TENS, we hypothesise that TENS when applied with enough stimulation intensity will be effective in reducing postoperative opioid use.

Trial website

Public notes

Contacts

Principal investigator

Name

A/Prof Greg O'Grady

Address

Department of Surgery University of Auckland ACH Support Building Level 12, Room 087 Park Road, Grafton 1145

Country

New Zealand

Phone

+64 274 222 989

Fax

greg.ogrady@auckland.ac.nz

Contact person for public queries

Name

William Xu

Address

Department of Surgery University of Auckland ACH Support Building Level 12, Room 087 Park Road, Grafton 1145

Country

New Zealand

Phone

+64 220720818

Fax

wxu958@aucklanduni.ac.nz

Contact person for scientific queries

Name

William Xu

Address

Department of Surgery University of Auckland ACH Support Building Level 12, Room 087 Park Road, Grafton 1145

Country

New Zealand

Phone

+64 220720818

Fax

wxu958@aucklanduni.ac.nz

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Will be available to other researchers/clinicians on request

Conditions for requesting access:
• -

What individual participant data might be shared?

• Quantitative results will be available. Qualitative surveys of patient tolerability will be deidentified first

What types of analyses could be done with individual participant data?

• Quantitative analysis

When can requests for individual participant data be made (start and end dates)?

From:
IPD will be available from 01/07/2020 to 01/07/2022

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• On request from authors via email
(wxu958@aucklanduni.ac.nz
OR greg.ogrady@auckland.ac.nz)

Are there extra considerations when requesting access to individual participant data?

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	Patient-Administered Transcutaneous Electrical Nerve Stimulation for Postoperative Pain Control After Laparoscopic Cholecystectomy: A Randomized, Sham-Controlled Feasibility Trial.	2020	https://dx.doi.org/10.1111/ner.13242

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

Trial Review

Documents added manually

Documents added automatically