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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blinded, randomised control trial to compare intraoperative morphine and methadone on the post-operative pain scores and analgesic requirements after shoulder arthroscopic surgery
Scientific title
In patients undergoing elective arthroscopic shoulder surgery, is a single intraoperative dose of intravenous morphine more effective than a single intraoperative dose of intravenous methadone in reducing post-operative analgesic patient-controlled-analgesia (PCA) requirements and visual analogue pain score (VAS)? A double-blinded, randomised control trial.
Secondary ID [1] 285428 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain 293187 0
Condition category
Condition code
Anaesthesiology 293461 293461 0 0
Pain management

Study type
Description of intervention(s) / exposure
Intravenous methadone will be injected at dose of 0.15mg/kg (0.1mg/kg if age >70) after induction and before initial incision
Intervention code [1] 290353 0
Treatment: Drugs
Comparator / control treatment
Intravenous morphine will be injected at a dose of 0.15mg/kg (0.1mg/kg if age >70) after induction and before initial incision
Control group

Primary outcome [1] 293281 0
Difference between total fentanyl PCA (patient-controlled analgesia) requirements. This is the total fentanyl requirements of participant after transfer from recovery and placed on PCA. This will be measured in micrograms.

Timepoint [1] 293281 0
Discharge home (day 1 post-operatively)
Secondary outcome [1] 310708 0
Difference between visual analogue scale scores post-operatively in recovery and 12 hours post-operatively (measuring post-operative pain)
Timepoint [1] 310708 0
In recovery and at 12 hours post-op
Secondary outcome [2] 310918 0
Difference in post-operative opiate related adverse events. This will be measured using a checklist by nursing staff who will tick whether or not the participants suffered from any of the following adverse effects:
-Post-operative nausea and vomiting
-Respiratory depression
Nursing staff will also detail in the questionnaire whether the participants required treatment for any of these (including anti-emetics, anti-histamines, opioid antagonists etc)
Timepoint [2] 310918 0
Up until 1 day post-op (discharge)
Secondary outcome [3] 314280 0
Difference between recovery fentanyl usage. Participants will be prescribed a total 100 micrograms of fentanyl (4x 25micrograms) on a as required basis (PRN). Total recovery fentanyl required in recovery before transfer to ward and placed on PCA will be recorded).
Timepoint [3] 314280 0
In recovery and before transfer to ward (immediately post-operatively- hours)

Key inclusion criteria
Consecutive patients admitted to Nepean Private Hospital during the study period who are undergoing shoulder arthroscopy
Able to give consent for procedure
Minimum age
18 Years
Maximum age
85 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Chronic opiate use (taken opiates regularly in the month before procedure)
Opiate use in previous 48 hours
History of drug abuse
Psychiatric history
Age under 18 and over 85
Chronic renal failure (eGFR < 30mL/min/1.73m^2)
Chronic liver failure (cirrhosis/fulminant liver failure)
Weight >120kg
Allergies to study drugs (morphine/methadone)
Known contraindications to methadone (hypothyroidism, Addison’s disease, prostatic hypertrophy, urethral stricture)
Taking medications known to induce or inhibit cytochrome p450 (antifungals, macrolide antibiotics, SSRIs, antivirals)
Individuals known to be pregnant
Those who are not suitable for PCA

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutive patients undergoing shoulder arthroscopy at Nepean Private Hospital by Dr Warren Kuo will be invited to participate in the study. They will receive a letter of invitation and patient information and consent form. If they are interested in participating in the study, the procedure and requirements will be explained to them and the consent form will be signed. Participant will be assigned a number generated from a random number table. This will be used to randomise the participant into each group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Numbers generated from a random number table will be placed into sealed, opaque envelopes by an investigator not involved with recruitment. When a participant in recruited, the investigator involved with recruitment will assign them with an envelope and hence a number. This number will be used to to randomise the participant into each group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis
Sample size calculation based on:
Retrospective audit data showing post-operative PCA fentanyl after intraoperative morphine procedures is 590 +/- 215 micrograms. Expected clinically relevant 25 percent reduction in post-operative PCA fentanyl after use of intraoperative methadone. Expected 5 patient in each group lost to follow up. Power and significance level for calculation: 0.05 (significance level), 0.80 (power).

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 3033 0
Nepean Private Hospital - Kingswood
Recruitment postcode(s) [1] 8753 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 290034 0
Self funded/Unfunded
Name [1] 290034 0
Address [1] 290034 0
Country [1] 290034 0
Primary sponsor type
Dr Edwin Khoo
Nepean Private Hospital
19 Barber Ave, Kingswood NSW 2747
Secondary sponsor category [1] 288725 0
Name [1] 288725 0
Address [1] 288725 0
Country [1] 288725 0

Ethics approval
Ethics application status
Ethics committee name [1] 291742 0
Nepean/Blue Mountains Health District Human Research Ethics Commitee
Ethics committee address [1] 291742 0
Ethics committee country [1] 291742 0
Date submitted for ethics approval [1] 291742 0
Approval date [1] 291742 0
Ethics approval number [1] 291742 0
HREC 14/50- HREC/14/NEPEAN/101

Brief summary
To assess the perioperative analgesic requirements of single dose intraoperative, intravenous methadone versus single dose, intraoperative, intravenous morphine during shoulder arthroscopy.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 51822 0
Dr Edwin Khoo
Address 51822 0
Nepean Private Hospital
19Barber Ave, Kingswood NSW 2747
Country 51822 0
Phone 51822 0
Fax 51822 0
+6129876 8655
Email 51822 0
Contact person for public queries
Name 51823 0
Dr Ravin Malinka Hettiarachchi
Address 51823 0
Concord Repatriation General Hospital, Hospital Road, Concord NSW 2139
Country 51823 0
Phone 51823 0
Fax 51823 0
Email 51823 0
Contact person for scientific queries
Name 51824 0
Dr Ravin Malinka Hettiarachchi
Address 51824 0
Concord Repatriation General Hospital, Hospital Road, Concord NSW 2139
Country 51824 0
Phone 51824 0
Fax 51824 0
Email 51824 0

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