Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001131943
Ethics application status
Approved
Date submitted
7/08/2020
Date registered
30/10/2020
Date last updated
4/08/2023
Date data sharing statement initially provided
30/10/2020
Date results information initially provided
22/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of methadone as pain relief in day-surgery patients undergoing a laparascopic gynaecological procedure
Scientific title
Investigating the post-operative opioid use of patients who received intraoperative methadone compared with those who received conventional potent opioids during laparoscopic gynaecological surgery - a double blind randomised controlled trial.
Secondary ID [1] 301968 0
Nil known
Universal Trial Number (UTN)
U1111-1256-5554
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain management 318527 0
Gynaecological laparoscopic surgery
 318945 0
Condition category
Condition code
Anaesthesiology 316531 316531 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intervention drug: Methadone (0.15mg/kg, up to 10mgs) as compared to standard care using morphine or fentanyl during laparoscopic procedure. this will be a single intra-operative dose administered via intravenous infusion. methadone will be administered at the time of incision closure.
Intervention code [1] 318256 0
Treatment: Drugs
Comparator / control treatment
methadone will be compared to standard care pain management procedures - intraoperative fentanyl (200microgram single dose intraoperatively through intravenous infusion)
Control group
Active

Outcomes
Primary outcome [1] 324666 0
Primary outcome
Opioid dose (in morphine equivalents) administered in the PACU
Assessed via recorded opioid use in PACU
Timepoint [1] 324666 0
- Opioid dose (in morphine equivalents) consumed in PACU
Secondary outcome [1] 385367 0
- Opioid dose (in morphine equivalents) administered prior to discharge from hospital
will be assessed from participant medical records
Timepoint [1] 385367 0
- Pain scores on arrival in PACU, every 15 min for the first hour, hourly for the next 4h, and prior to discharge.
Secondary outcome [2] 387488 0
- Pain scores on arrival in PACU, every 15 min for the first hour, hourly for the next 4 h, and prior to discharge
will be assessed by research team present in PACU
Timepoint [2] 387488 0
every 15 min for the first hour, hourly for the next 4 h, and prior to discharge
Secondary outcome [3] 387489 0
- Respiratory complications in PACU (e.g. respiratory depression, oxygen desaturation)
Will be assessed by research team present in PACU
Timepoint [3] 387489 0
Throughout time in PACU
Secondary outcome [4] 387490 0
Rate of admission to hospital for analgesia
will be assessed from participant medical records,
Timepoint [4] 387490 0
whether patient represents to hospital for pain complaints within 1 week post-procedure
Secondary outcome [5] 387491 0
- Opioid dose (in morphine equivalents) consumed after discharge, at one week
will be assessed by phone follow up at one week post-discharge
Timepoint [5] 387491 0
one week post-discharge

Eligibility
Key inclusion criteria
- Adults undergoing general surgery laparoscopy as well as gynaecology laparoscopy at Albury and Wodonga Hospitals
- Planned same-day discharge
- Able to speak and read English
Minimum age
18 Years
Maximum age
78 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Morbid obesity
- Obstructive sleep apnoea, treated with CPAP, or diagnosed but untreated
- Significant renal or liver dysfunction
- Pregnant or breastfeeding women
- Preoperative opioid dependence
- Known or suspected allergy to methadone
- Anaesthetist wish to avoid methadone administration for any reason
- Undergoing laparoscopic bowel resection or laparoscopic nephrectomy
- Undergoing emergency laparoscopic operations (e.g. appendicectomy, ectopic pregnancy)
- Patients with long QT syndrome, and any on whom a preop ECG reveals a long QT interval
- Anyone already on an SSRI (serotonin syndrome risk)

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)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
utilising local hospital records and previous studies, the power of the study and sample size was estimated

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/12/2020
Actual
13/01/2021
Date of last participant enrolment
Anticipated
2/02/2022
Actual
11/05/2022
Date of last data collection
Anticipated
9/02/2022
Actual
18/05/2022
Sample size
Target
70
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 17206 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [2] 17207 0
Albury Wodonga Health - Wodonga campus - Wodonga
Recruitment postcode(s) [1] 30914 0
2640 - Albury
Recruitment postcode(s) [2] 30915 0
3690 - Wodonga

Funding & Sponsors
Funding source category [1] 306660 0
Self funded/Unfunded
Name [1] 306660 0
Country [1] 306660 0
Primary sponsor type
University
Name
University of New South Wales
Address
Street Address
559 East Street,
Albury,
NSW, 2640

Mailing Address
PO Box 3004,
Albury,
NSW, 2640
Country
Australia
Secondary sponsor category [1] 307208 0
None
Name [1] 307208 0
Address [1] 307208 0
Country [1] 307208 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306590 0
The Albury Wodonga Health Human Research Ethics Committee
Ethics committee address [1] 306590 0
559 East Street,
Albury,
NSW, 2640
Ethics committee country [1] 306590 0
Australia
Date submitted for ethics approval [1] 306590 0
12/08/2020
Approval date [1] 306590 0
13/10/2020
Ethics approval number [1] 306590 0
66418

Summary
Brief summary
Methadone is an opioid medication used as a pain reliever medication and as a way of reducing withdrawal symptoms for those patients addicted to opioids. It is in the same class of drugs as codeine, oxycodone, morphine and fentanyl. These drugs are commonly employed to manage acute pain, such as that inflicted by surgery. Due to opioids having significant side effects alongside addictive properties, reducing the dose of such potent drugs is important, especially to avoid patients becoming dependent on them. Such adverse effects range from nausea, constipation and sedation to respiratory suppression, overdose and death.

Laparoscopic surgery is a minimally invasive, moderately painful procedure commonly employed in general and gynaecological cases. Such procedures, especially gynaecological surgeries can be notoriously difficult to manage post-operative pain where no ideal analgesic regimen has been established. Conventionally, potent opioids like fentanyl and morphine are employed during surgery with patients frequently requiring opioids in both the PACU, and after discharge. This carries substantial risks and adverse effects.

Methadone may offer an appealing alternative to current strategies. If the amount of post-operative opioid required can be reduced, not only will patients benefit in terms of greater comfort and fewer dose-related opioid adverse effects, but recent concerns about overprescribing of discharge opioids may be alleviated

Hypothesis
This study hypothesises that intraoperative methadone use will reduce PACU opioid consumption. As a result, we also predict that we will be able to reduce opioid dose (in morphine equivalents) consumed after discharge, at one week.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104390 0
Mr Kyle Green
Address 104390 0
University of New South Wales, 559 East St, East Albury NSW 2640
Country 104390 0
Australia
Phone 104390 0
+61 400639923
Fax 104390 0
Email 104390 0
[email protected]
Contact person for public queries
Name 104391 0
Mr Kyle Green
Address 104391 0
University of New South Wales

559 East Street,
Albury,
NSW, 2640
Country 104391 0
Australia
Phone 104391 0
+61 400639923
Fax 104391 0
Email 104391 0
[email protected]
Contact person for scientific queries
Name 104392 0
Dr Luke Baitch
Address 104392 0
Albury Wodonga Health

559 East Street,
Albury,
NSW, 2640
Country 104392 0
Australia
Phone 104392 0
+61 408586318
Fax 104392 0
Email 104392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The consent obtained for patients in this trial has precluded data sharing of individual patient data. Aggregate data will be available for use in further investigation.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19033Study protocol  [email protected]
19034Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.