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Trial registered on ANZCTR

Registration number

ACTRN12616000919415

Ethics application status

Approved

Date submitted

3/04/2016

Date registered

11/07/2016

Date last updated

16/06/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Use of Patient Controlled Analgesics in the management of pain in Orthognathic Surgery – A randomised controlled trial pilot study

Scientific title

Use of Patient Controlled Analgesics in the management of pain in Orthognathic Surgery – A randomised controlled trial pilot study

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1181-3681

Trial acronym

Linked study record

Health condition

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

Post surgery pain management

Condition category

Condition code

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Following orthognathic surgery (corrective jaw surgery), patients are randomised into control group and exposure group.
The exposure group will be administered a Patient Controlled Analgesics (PCA) on top of their regular pain relief.
The patients in the PCA group will follow the PCA protocol of 100microgram of fentanyl per delivery with a lock out time of 5 minutes. The patient will be given a push button which is connected to the PCA machine. At each press of the button, the machine will deliver 100micrograms of fentanyl. with a lock out time of 5 minutes. This means that patient will receive 12 doses of 100 micrograms of fentanyl per hour. There are no limits on the dosing per day.
The regular pain medications will be Paracetamol 1g every 6 hours, Ibuprofen 400mg every 6 hours or Celebrex 100mg every 12 hours. These medications will be given as tablets.
The PCA and oral pain relief will be administered until patient is discharged

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Following orthognathic surgery (corrective jaw surgery), patients are randomised into control group and exposure group.
The control group will only receive oral pain relief administered orally by the nursing staff.
This includes Paracetamol 1gram every 6 hourly, Ibuprofen 400mg every 8 hourly or Celebrex 100mg every 12 hours, Tramadol immediate release 100mg every 6 hours (with maximum of 400mg per 24hr) as required (PRN), and Oxynorm 5mg every 4 hours as requried (PRN).
These medications will be given until discharge. These patients will be discharged on Paracetamol 1g every 6 hours for 7 days, Ibuprofen 400mg every 8 hours for 7 days and oxynorm 5mg every 4 hours for 3 days.

Control group

Active

Outcomes

Primary outcome [1]

Length of hospital stay from the day of surgery to discharge from hospital.
This outcome is assessed by the way of review of medical records

Timepoint [1]

The outcome is assessed after the patient is discharge from the hospital

Primary outcome [2]

Visual analogue pain score

Timepoint [2]

Pain score is measured from 8am the day after surgery and is measured every hour until patient is discharged

Secondary outcome [1]

Health economics - the cost of hospital stay for each patient, cost of using patient controlled analgesias. This will involve the review of medical records on how many days patient has stayed post surgery and the amount of patient controlled analgesics used during the post operative period.
The analysis required for the health economics will involve cost-minimization analysis, cost–benefit analysis and cost-effectiveness analysis

Timepoint [1]

Assessed after the patient is discharged

Eligibility

Key inclusion criteria

Sample group will be ASA 1 or 2 patients who have no significant prior medical problems (including any cardiac history, respiratory disease, chronic pain issues or on any regular pain relief for chronic pain or arthritic pains) and are having Orthognathic surgery will be recruited for this study. All ages and genders are included. They will be fully informed and given the option to agree or deny participation into the study and will be consented for this study.

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

ASA 3, ASA 4, ASA 5
Chronic pain
Fibromyalgia
Syndromic

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 not concealed

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

Simple randomisation using a randomisation table created by computer software from https://www.sealedenvelope.com

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data will be analysed with Intention to treat analysis
This is a pilot study, therefore will fulfil ethics approval requirement of involving 40 patients in the trial.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

23/04/2015

Date of last participant enrolment

Anticipated

1/08/2017

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Royal Perth Hospital - Perth

Recruitment hospital [2]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

6000 - Perth

Recruitment postcode(s) [2]

6150 - Murdoch

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Perth Hospital

Address [1]

197 Wellington St
Perth 6000
Western Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Perth Hospital

Address

197 Wellington St
Perth 6000
Western Australia

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Fiona Stanley Hospital

Address [1]

Department of Oral and Maxillofacial Surgery
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch 6150
Western Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Government of Western Australia Department of Health South Metropolitan Health Service Human Research Ethics Committee

Ethics committee address [1]

Research and Governance and Ethics Office
Fremantle Hospital
PO Box 480 
Fremantle, WA, 6959

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/10/2013

Approval date [1]

16/10/2013

Ethics approval number [1]

13/88

Summary

Brief summary

The aim of this project is to show whether if there is a difference in the length of hospital stay and effect on health economics for patients who are using ‘patient controlled analgesics’ (PCA) compared to those patients who are on conventional oral or intravenous pain relief administered by nurse. 
The significance of this project is that, if there is a difference between the two groups, PCA and conventional pain relief group, this can help improve the cost of service to the patient. Reduced length of hospital stay means earlier discharge for the patients to their own environment for recovery and prevents nosocomial infections, this will also free up hospital bed for other patients and reduce the cost of administering PCA. 
The research question is whether there is a difference in the length of hospital stay for patients who are using PCA compared to conventional analgesics after orthognathic jaw surgery. 
Our hypothesis is that, those patients who are on PCA will have prolonged hospital stay compared to those who are on conventional oral or intravenous analgesics.

Trial website

Trial related presentations / publications

Public notes

Orthognathic surgery (jaw corrective surgery) is carried out for patients who have jaw (maxilla and/or mandible) size/length/width or relationship discrepancy or masticatory function problem or obstructive sleep apnoea. These patients require orthodontic treatment combined with Orthognathic surgery that could involve one jaw or both jaws. In most cases post operative pain is controlled with routine regular simple analgesics orally. However there are cases where patient would be prescribed with ‘patient controlled analgesics’, that are self-administered morphine or fentanyl via a pump, controlled by patient with a lockout time. Clinical observations showed that when patients are prescribed the PCA, it increased the length of hospital stay due to prolonged immobility and side effects from the use of PCA medication such as nausea, vomiting and decreased sensorium and also the use of indwelling catheter which also delays the discharge of patient from the hospital.

This project is to compare the length of hospital stay for patients using PCA versus conventional analgesics and the effectiveness of pain control during the recovery period, side effects and impact on health economics for those patients who are on PCA versus those on conventional analgesics (oral or iv administered by nurse). The oral analgesics will be of same action and class as the intravenous pain relief given in the PCA pump, therefore the practice of pain relief remains the same but via a different route of administration.

Attachments [1]

/AnzctrAttachments/370417-Pain flowchart 4.3.jpg

Contacts

Principal investigator

Name

Dr Frank Chang

Address

Department of Oral and Maxillofacial Surgery
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch 6150
Western Australia

Country

Australia

Phone

+61405981551

Fax

[email protected]

Contact person for public queries

Name

Frank Chang

Address

Department of Oral and Maxillofacial Surgery
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch 6150
Western Australia

Country

Australia

Phone

+61405981551

Fax

[email protected]

Contact person for scientific queries

Name

Frank Chang

Address

Department of Oral and Maxillofacial Surgery
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch 6150
Western Australia

Country

Australia

Phone

+61405981551

Fax

[email protected]

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		RESULTS: Randomization resulted in approximately ... [More Details]
Study results article	Yes		Chang FS, Burrows SA, Gebauer DP. Patient-Controll... [More Details]	370417-(Uploaded-09-05-2020-19-42-04)-Journal results publication.pdf

Documents added automatically

No additional documents have been identified.

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